Eli Lilly is launching a clinical trial of lepodisiran for people with high Lipoprotein(a)—an inherited risk factor for heart attacks and strokes. Researchers aim to find out if the new drug can do more than just lower blood test numbers by actually impacting coronary plaques.

Most people associate cholesterol management with diet, weight, and lifestyle changes. But there is another metric that patients often only discover by accident: Lipoprotein(a), or Lp(a). It is frequently referred to as a "hidden" cardiovascular risk because Lp(a) levels are largely determined by genetics and remain virtually unaffected by exercise or a healthy diet.

Now, this inherited risk factor is the focus of a new clinical trial by Eli Lilly. The trial, registered in the ICH GCP database under the identifier NCT07613294 and known as ACCLAIM-CTA, will test the experimental drug lepodisiran in adults with elevated Lp(a) who already have atherosclerotic cardiovascular disease or are at high risk for a first major cardiovascular event.

What is Lp(a) and why is it making headlines?

Lp(a) is a particle in the blood similar to "bad" LDL cholesterol, but it carries an additional protein component. When Lp(a) levels are consistently high, the risk of developing atherosclerosis, heart attacks, and strokes increases significantly. A person can feel perfectly healthy and have no idea there is a problem unless a doctor specifically orders this blood test.

The American Heart Association (AHA) notes that Lp(a) levels are primarily inherited. According to their data, approximately one in five people has elevated Lp(a). This makes the topic highly relevant to a broad audience: a person might lead an ideal, active lifestyle but still carry this hidden genetic burden.

What exactly will the trial test?

ACCLAIM-CTA is a Phase 3, randomized, double-blind, placebo-controlled trial. According to the ICH GCP registry, it plans to enroll 252 adult participants.

Patients will receive subcutaneous injections of either lepodisiran or a placebo. The primary goal is to evaluate how the drug affects the volume and type of plaque in the coronary arteries compared to the placebo. To measure this, researchers will use CCTA (Coronary Computed Tomography Angiography), an advanced imaging technique for the heart's blood vessels.

The primary endpoint of the study is the percentage change in non-calcified plaque volume from baseline to week 104. Simply put, scientists want to see more than just a drop in Lp(a) on a lab report; they want to observe real, positive changes in the structure of atherosclerosis inside the arteries.

Why is this more important than just "lowering a number"?

For a patient, a perfect lab result is not the ultimate goal. The crucial clinical question is: if we lower Lp(a) with medication, will it actually reduce the risk of heart attacks, strokes, or plaque progression?

Early studies of lepodisiran have already demonstrated its ability to cause deep and prolonged reductions in Lp(a). For instance, data shared by the Cleveland Clinic from a Phase 2 trial showed that a single 400 mg dose lowered median Lp(a) levels by about 94% between days 60 and 180. However, lowering a blood marker does not automatically prove that a drug prevents heart attacks or clears dangerous plaques.

This is why ACCLAIM-CTA is so compelling. It looks directly at the heart's arteries using precise imaging. This represents a vital intermediate step between "the blood number went down" and "fewer people are having severe heart attacks."

What cannot be claimed yet

At this stage, it absolutely cannot be stated that lepodisiran prevents heart attacks, stops strokes, or "cleans out arteries." The ACCLAIM-CTA trial has not produced any results yet. In fact, according to the ICH GCP registry, its status is currently "not yet recruiting."

Furthermore, lepodisiran should not be viewed as an available treatment for high Lp(a). It remains an investigational drug, and its actual clinical benefit in preventing real-world cardiovascular events must be rigorously proven in large, multi-year outcome trials.

The strength of this news lies in how it addresses a very common human question: why do some people suffer from heart disease despite eating right and having normal standard cholesterol? Lp(a) is a crucial part of that answer, and science is now actively testing tools to manage this specific risk.

Primary source: ICH GCP: NCT07613294.
Additional context: American Heart Association: Lipoprotein(a); Cleveland Clinic: phase 2 lepodisiran trial; JAMA: phase 1 lepodisiran trial.

Eli Lilly is launching a clinical trial of lepodisiran for people with high Lipoprotein(a)—an inherited risk factor for heart attacks and strokes. Researchers aim to find out if the new drug can do more than just lower blood test numbers by actually impacting coronary plaques.

Most people associate cholesterol management with diet, weight, and lifestyle changes. But there is another metric that patients often only discover by accident: Lipoprotein(a), or Lp(a). It is frequently referred to as a "hidden" cardiovascular risk because Lp(a) levels are largely determined by genetics and remain virtually unaffected by exercise or a healthy diet.

Now, this inherited risk factor is the focus of a new clinical trial by Eli Lilly. The trial, registered in the ICH GCP database under the identifier NCT07613294 and known as ACCLAIM-CTA, will test the experimental drug lepodisiran in adults with elevated Lp(a) who already have atherosclerotic cardiovascular disease or are at high risk for a first major cardiovascular event.

What is Lp(a) and why is it making headlines?

Lp(a) is a particle in the blood similar to "bad" LDL cholesterol, but it carries an additional protein component. When Lp(a) levels are consistently high, the risk of developing atherosclerosis, heart attacks, and strokes increases significantly. A person can feel perfectly healthy and have no idea there is a problem unless a doctor specifically orders this blood test.

The American Heart Association (AHA) notes that Lp(a) levels are primarily inherited. According to their data, approximately one in five people has elevated Lp(a). This makes the topic highly relevant to a broad audience: a person might lead an ideal, active lifestyle but still carry this hidden genetic burden.

What exactly will the trial test?

ACCLAIM-CTA is a Phase 3, randomized, double-blind, placebo-controlled trial. According to the ICH GCP registry, it plans to enroll 252 adult participants.

Patients will receive subcutaneous injections of either lepodisiran or a placebo. The primary goal is to evaluate how the drug affects the volume and type of plaque in the coronary arteries compared to the placebo. To measure this, researchers will use CCTA (Coronary Computed Tomography Angiography), an advanced imaging technique for the heart's blood vessels.

The primary endpoint of the study is the percentage change in non-calcified plaque volume from baseline to week 104. Simply put, scientists want to see more than just a drop in Lp(a) on a lab report; they want to observe real, positive changes in the structure of atherosclerosis inside the arteries.

Why is this more important than just "lowering a number"?

For a patient, a perfect lab result is not the ultimate goal. The crucial clinical question is: if we lower Lp(a) with medication, will it actually reduce the risk of heart attacks, strokes, or plaque progression?

Early studies of lepodisiran have already demonstrated its ability to cause deep and prolonged reductions in Lp(a). For instance, data shared by the Cleveland Clinic from a Phase 2 trial showed that a single 400 mg dose lowered median Lp(a) levels by about 94% between days 60 and 180. However, lowering a blood marker does not automatically prove that a drug prevents heart attacks or clears dangerous plaques.

This is why ACCLAIM-CTA is so compelling. It looks directly at the heart's arteries using precise imaging. This represents a vital intermediate step between "the blood number went down" and "fewer people are having severe heart attacks."

What cannot be claimed yet

At this stage, it absolutely cannot be stated that lepodisiran prevents heart attacks, stops strokes, or "cleans out arteries." The ACCLAIM-CTA trial has not produced any results yet. In fact, according to the ICH GCP registry, its status is currently "not yet recruiting."

Furthermore, lepodisiran should not be viewed as an available treatment for high Lp(a). It remains an investigational drug, and its actual clinical benefit in preventing real-world cardiovascular events must be rigorously proven in large, multi-year outcome trials.

The strength of this news lies in how it addresses a very common human question: why do some people suffer from heart disease despite eating right and having normal standard cholesterol? Lp(a) is a crucial part of that answer, and science is now actively testing tools to manage this specific risk.

Primary source: ICH GCP: NCT07613294.
Additional context: American Heart Association: Lipoprotein(a); Cleveland Clinic: phase 2 lepodisiran trial; JAMA: phase 1 lepodisiran trial.

Pfizer is launching a study to evaluate the safety of taking a second dose of rimegepant during a migraine attack if the pain does not fully resolve or returns. While this addresses a highly practical question for patients, medical experts emphasize that it is not yet an approved treatment rule.

A migraine is rarely just a standard headache. An attack can be accompanied by nausea, sensitivity to light and sound, and the feeling that normal life has come to a complete halt. For patients, the question isn't just "is there a medication?", but a more practical one: what should be done if the first dose doesn't completely work?

This exact scenario is the focus of a new Pfizer clinical trial, registered in the ICH GCP database under the identifier NCT07609914. Researchers aim to assess the safety, tolerability, and efficacy of redosing rimegepant during an acute migraine attack in adults.

What is rimegepant?

Rimegepant belongs to a class of drugs known as gepants. It specifically blocks the CGRP receptor—a molecule that plays a significant role in the mechanisms of migraine pain. In the U.S., the drug is marketed under the brand name Nurtec ODT and is approved for adults both to treat acute migraine attacks and to prevent episodic migraines.

It is neither a triptan nor a traditional painkiller. Gepants emerged as a distinct class of medication targeting one of the key biological pathways of a migraine. This is particularly important for patients who cannot tolerate classic triptans or for whom they are ineffective.

What exactly will be tested?

According to the ICH GCP registry, this is a Phase 4 study. This means it is not the initial testing of a brand-new compound, but rather a deeper, supplementary investigation of an already approved drug in a specific clinical situation.

The trial plans to enroll 400 adult patients with migraines. Participants will take rimegepant 75 mg in the form of an orally disintegrating tablet (ODT) to treat attacks of moderate or severe intensity.

The key aspect of the trial is the option to redose. If a participant is not pain-free approximately two hours after the initial dose, or if the headache returns after initial relief, the protocol allows for a second 75 mg dose of rimegepant within 24 hours of the first.

Why does this matter?

For people living with migraines, an incomplete response to treatment is a frequent and very real problem. Sometimes a medication reduces the intensity of the pain but fails to restore the person to normal activity. Other times, the pain subsides only to return later the same day. In these situations, patients and doctors are forced to look for additional relief options.

This is why the study is of broad interest. It does not promise a "stronger" migraine cure, but rather tests a narrow, highly relevant question: how safe and effective is taking a second dose of rimegepant during a single attack if the first dose fell short?

Why caution is needed with this topic

Currently, according to the official FDA prescribing information for Nurtec ODT, the maximum allowed dose of rimegepant in a 24-hour period is 75 mg (one tablet). The label also notes that the safety of using more than 18 doses in a 30-day period has not been established.

Therefore, this new study must not be interpreted as permission to take a second pill on your own. On the contrary, its purpose is to rigorously test an approach that should not yet be adopted as everyday advice. Redosing is being studied exclusively within a clinical protocol, with strict inclusion criteria and medical oversight.

What cannot be claimed yet

At this stage, it cannot be claimed that taking two doses of rimegepant in 24 hours is safe for general use or works better for migraines than the currently approved regimen. The study has yet to gather reliable data on tolerability, potential side effects, and the actual clinical benefit of this approach.

The strength of this news is that it directly addresses everyday patient experiences. Many have faced a situation where an attack seemed to weaken but didn't end. Now, this scenario is being studied officially—not as an internet forum tip, but as a serious clinical question requiring evidence-based answers.

Primary source: ICH GCP: NCT07609914.
Additional context: FDA prescribing information for Nurtec ODT; The Journal of Headache and Pain: safety study of once-daily rimegepant 75 mg.

Yale University is launching a clinical trial of psilocybin-assisted therapy for patients with Parkinson’s disease and depression. Interest in the approach has surged following a recent pilot study, but experts warn this is an early stage of research and it is still too soon to call it a proven treatment.

Parkinson’s disease is traditionally associated with tremors, stiffness, and slowed movements. However, for many patients, the non-motor symptoms—such as deep depression, anxiety, sleep disturbances, apathy, and a sharp decline in overall quality of life—are just as debilitating a part of the diagnosis.

This is why the medical community's attention has been drawn to a new Yale University clinical trial, registered in the ICH GCP database under the identifier NCT07610369. Researchers aim to determine whether therapy utilizing psilocybin can safely and effectively alleviate symptoms of depression in people living with this neurodegenerative condition.

What exactly will be studied?

Psilocybin is a psychoactive substance that is currently being heavily researched under strictly controlled clinical conditions for various psychiatric disorders. It is crucial to understand that this trial is not about recreational use or finding a "natural remedy." Participants will receive the drug exclusively in a medical setting, under constant clinical supervision, and in combination with professional psychotherapeutic support.

According to the registry, this is a Phase 2 randomized controlled trial. It plans to enroll 40 participants with clinically confirmed early to moderate-stage Parkinson’s disease who also have at least moderate depression.

Patients will undergo two dosing sessions: starting with a low dose (often referred to as a "microdose") and progressing to a higher dose. Mandatory psychotherapy sessions are scheduled before and after each drug administration. Medical observation of the participants will continue for up to three months following the second session.

Why is this particularly important for Parkinson's?

Depression in Parkinson’s disease is not simply a psychological reaction to a severe diagnosis. It is often an organic part of the disease itself, directly linked to structural and chemical changes in the brain. Because of this, standard antidepressants and conventional treatment approaches do not always work as effectively as desired.

For patients, this is a highly practical issue. Even if motor symptoms are partially controlled by medication, depression can devastate daily life: it saps motivation, exacerbates physical fatigue, and hinders effective rehabilitation and communication with loved ones.

Why is this topic emerging now?

The surge of interest in this trial is largely due to the results of a previous, smaller study. In an open-label pilot trial, 12 participants with Parkinson’s disease and symptoms of depression or anxiety received psilocybin alongside psychotherapy. The authors reported no serious adverse effects and noted signs of improved mood, reduced anxiety, as well as some positive shifts in cognitive and motor metrics.

However, that pilot had significant limitations: a very small sample size (only 12 people), an open-label design (meaning participants knew what they were taking), and no placebo group. Under such conditions, science cannot confidently separate the drug's actual biological effect from the placebo effect, patient expectations, and the benefits of talking with a therapist.

The new Yale University study, conducted in partnership with the University of California, San Francisco (UCSF), is designed to be a much more rigorous test. Researchers intend not only to evaluate the dynamics of depressive symptoms using clinical scales but also to attempt to understand what specific changes are occurring in the patients' brains.

What cannot be claimed yet

At this stage, it absolutely cannot be stated that psilocybin cures depression in Parkinson’s disease, improves motor functions, or slows the progression of the disease. Furthermore, the encouraging results of a small pilot study cannot be automatically generalized to all patients with this diagnosis.

Serious safety questions also remain. Psilocybin can profoundly affect perception, emotions, blood pressure, and overall mental state. For individuals with neurodegenerative changes, this is a high-risk zone, which is exactly why such trials are conducted exclusively in tightly controlled environments with strict candidate screening.

The primary value of this news does not lie in the promise of a quick, "magical" cure. Rather, it is that depression in Parkinson’s is finally being addressed as an independent, severe clinical problem that requires fundamentally new approaches and high-quality, evidence-based research.

Primary source: ICH GCP: NCT07610369.
Additional context: Yale School of Medicine: New Clinical Trial Aims to Treat Depression in People with Parkinson’s Disease; Neuropsychopharmacology: Psilocybin therapy for mood dysfunction in Parkinson’s disease.

Novo Nordisk is launching a trial of cagrilintide for individuals with obesity who had to stop GLP-1 therapy due to gastrointestinal side effects. This is not a ready-made "Ozempic alternative," but rather an early tolerability test for a medication with a completely different mechanism of action.

GLP-1 medications have transformed the treatment of obesity and type 2 diabetes, but they are not suitable for everyone. A significant number of patients are forced to discontinue therapy due to severe gastrointestinal side effects, such as nausea, vomiting, diarrhea, constipation, or pronounced discomfort.

For this specific group, Novo Nordisk is initiating a new clinical trial for the drug cagrilintide. The trial is registered on the ICH GCP portal under the identifier NCT07607587. The full title reflects its primary objective: to evaluate the tolerability of cagrilintide in people with obesity who have previously discontinued GLP-1 receptor agonists due to gastrointestinal adverse events.

What is cagrilintide?

It is important to note that cagrilintide is not another GLP-1 drug. It is a long-acting analogue of amylin—a hormone naturally involved in regulating appetite and the feeling of fullness. In simple terms, this medication operates through a different biological pathway than semaglutide and similar drugs.

This is precisely why the topic is highly relevant. While there is currently a lot of hype surrounding GLP-1s, real-world clinical practice faces a much more grounded and pressing question: what options are available for people with obesity who simply cannot tolerate these popular medications?

What exactly will be tested?

According to the ICH GCP registry, this is a randomized, double-blind trial. Participants will be randomly assigned to receive either cagrilintide or a placebo. The medication is administered subcutaneously. The treatment period is set for 26 weeks, with the entire clinical observation lasting approximately eight months.

The study plans to enroll 114 adults with obesity. Key inclusion criteria require a body mass index (BMI) of 30 kg/m² or higher, along with a documented history of GLP-1 treatment that was stopped specifically because of stomach or intestinal issues.

Notably, this trial is not designed for people with diabetes. The exclusion criteria clearly rule out individuals with type 1 or type 2 diabetes, elevated HbA1c levels in the diabetic range, and recent use of glucose-lowering medications.

Why does this matter?

The main intrigue of this study is not whether cagrilintide will prove "stronger" than current weight-loss blockbusters. Instead, the focus is on quality of life: will people who could not tolerate GLP-1 therapy be able to remain on a standard or higher dose of cagrilintide by week 26?

This makes the news less sensational, but far more meaningful for actual patients. For an individual, the abstract percentage of weight lost is often secondary to the ability to undergo treatment without debilitating side effects that disrupt daily life.

What cannot be claimed yet

At this stage, it cannot be stated that cagrilintide is a proven alternative to GLP-1s for patients with obesity. Furthermore, there are no guarantees that it will definitely be better tolerated by those who have already quit GLP-1s due to GI distress.

Cagrilintide already has published early data regarding its efficacy in obesity, including a study in The Lancet. However, this new trial is designed to answer a distinct question: not just whether the drug can induce weight loss, but whether it serves as a viable "backup plan" when first-line therapy is intolerable.

An honest takeaway is that this research should not be viewed as a promise of a "perfect weight-loss injection," but as an important step toward personalized medicine. Not all patients respond to the same mechanisms, and medical science is gradually exploring more individualized treatment options.

Primary source: ICH GCP: NCT07607587.
Additional context: The Lancet: once-weekly cagrilintide for weight management.

A new clinical trial, FAVES-B, is preparing to launch in the U.S. to determine whether the non-hormonal drug fezolinetant—currently used for hot flashes—impacts vascular and cognitive health. While this explores a crucial question, experts emphasize that it does not yet prove the treatment protects the heart or brain.

Menopause hot flashes are often described as a sudden wave of heat, sweating, facial flushing, and nighttime awakenings. For many women, this is not merely a "minor discomfort," but a disruptive symptom that interferes with sleep, work, and daily life.

Now, researchers are looking at this issue through a broader lens. A clinical trial, NCT07606664 (also known as FAVES-B), has been registered in the U.S. Its goal is to determine whether fezolinetant impacts vascular and cognitive health in women experiencing moderate to severe menopausal hot flashes and night sweats.

What is this drug?

Fezolinetant is a non-hormonal medication. In the U.S., it is marketed under the brand name Veozah and is FDA-approved for the treatment of moderate to severe vasomotor symptoms due to menopause—namely, hot flashes and night sweats.

It does not function like traditional hormone therapy. Instead, the drug blocks the neurokinin 3 (NK3) receptor, which plays a role in the brain's thermoregulation mechanisms. Simply put, it intervenes in the system that can easily trigger a "heat signal" during menopause.

What exactly will the new study test?

FAVES-B is a Phase 3, randomized, double-blind, placebo-controlled trial. According to the registry, it plans to enroll 220 women with moderate to severe hot flashes and night sweats.

Participants will be randomly assigned to one of two groups: one will take 45 mg of fezolinetant once daily for 12 weeks, while the other will receive a placebo. Neither the participants nor the research team will know who is receiving the active drug and who is getting the placebo tablet.

The primary interest of the study goes beyond just the frequency of hot flashes. Researchers will evaluate vascular function and verbal memory—the ability to remember and recall words. They will also track sleep patterns and objective measures of hot flashes.

Why does this matter?

For a long time, hot flashes were viewed primarily as an unpleasant but temporary symptom of menopause. However, in recent years, there has been growing interest in whether severe and frequent vasomotor symptoms might be linked to broader health risks, such as declining vascular health, poor sleep quality, and cognitive changes.

This is why the trial is of interest to a wide audience. It does not promise that the drug will "protect the brain" or "prevent heart disease." But it asks a crucial question: if hot flashes are effectively reduced, will the metrics associated with vascular and brain health also improve?

What cannot be claimed yet

According to the trial registry, FAVES-B is not yet recruiting participants; the estimated start date is September 2026. This means there are no results yet.

It cannot be claimed that fezolinetant improves memory, protects blood vessels, or reduces the risk of dementia and cardiovascular diseases. So far, the drug has proven its efficacy specifically for moderate to severe menopausal hot flashes, and this new research is designed to explore these secondary questions.

There is also an important safety consideration. The current FDA prescribing information for Veozah includes a warning about the risk of liver damage and the need to monitor liver blood tests before starting and during treatment. Therefore, any discussions about the drug's expanded benefits must be accompanied by a careful review of its risks.

The core news here is not the arrival of a "memory drug for menopause." Rather, it is that a well-known non-hormonal treatment for hot flashes is now being studied in a much broader context—encompassing vascular health, brain function, sleep, and overall quality of life.

Primary source: ICHGCP: NCT07606664.
Additional context: FDA: approval of Veozah / fezolinetant; FDA prescribing information for Veozah.

A small trial of the drug HEC88473 in women with polycystic ovary syndrome (PCOS) has been registered in China. Researchers aim to discover if a dual GLP-1/FGF21 mechanism can address the metabolic imbalances of PCOS, though this remains an early-stage investigation, not a proven treatment.

Polycystic ovary syndrome (PCOS) is frequently viewed simply as a gynecological issue—marked by irregular cycles, acne, excess hair growth, or fertility challenges. But for many women, it is fundamentally a metabolic story. The condition is closely tied to insulin resistance, excess weight, lipid imbalances, and a higher risk of type 2 diabetes.

That is why a new clinical trial, registered on ClinicalTrials.gov under the identifier NCT07616037, has caught the medical community's attention. Hosted by Zhongshan Hospital at Fudan University in Shanghai, this Phase 2 study plans to enroll 30 women diagnosed with PCOS.

What exactly are they testing?

Researchers are evaluating HEC88473, a dual GLP-1 and FGF21 receptor agonist. Simply put, this compound targets two pathways simultaneously to regulate blood sugar, fat metabolism, and insulin sensitivity.

The term "GLP-1" is already widely recognized thanks to popular medications for type 2 diabetes and obesity. Consequently, any new research in this area quickly makes headlines. However, it is crucial to remain objective: HEC88473 is not an Ozempic clone, nor is it a ready-made cure for PCOS. It is an experimental drug just beginning its clinical evaluation in this specific patient group.

Why a metabolic approach matters for PCOS

According to the World Health Organization, PCOS affects approximately 10–13% of women of reproductive age. For a significant portion of these patients, the condition involves not only hormonal disruptions but serious metabolic dysfunctions.

Modern medicine is increasingly looking at PCOS through a broader lens. It is no longer seen solely as an ovarian problem, but as a complex condition where the hormonal and metabolic systems are deeply intertwined. The 2023 International Evidence-based Guideline for PCOS also places a strong emphasis on managing metabolic risks and personalizing patient care.

What we already know about HEC88473

HEC88473 has some early clinical data in another medical context. The drug was previously studied in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and type 2 diabetes. In those trials, it demonstrated an ability to influence liver fat, blood glucose levels, insulin resistance, and lipid profiles.

However, these findings cannot be automatically applied to PCOS. Women with polycystic ovary syndrome represent a distinct clinical group with unique goals: regulating the menstrual cycle, managing hyperandrogenism, preserving fertility, and achieving long-term weight control. The new Shanghai trial is designed precisely to determine whether the drug has clinical value in this complex context.

What doctors are warning against

At this stage, no one can claim that HEC88473 effectively treats PCOS. There is no proof yet that it improves cycles, lowers androgen levels, increases pregnancy chances, or is safe for broad use among these patients. Registering a trial and recruiting participants is not a guarantee of clinical efficacy.

The real value of this news lies elsewhere: it highlights a global shift in how science approaches PCOS. The condition is steadily moving beyond the confines of traditional gynecology. If new metabolically targeted therapies prove their worth in large, high-quality trials, it could radically change the standard of care for women. But reaching those conclusions will still take a significant amount of time.

Primary source: ICHGCP.NET: NCT07616037.
Additional context: WHO: Polycystic ovary syndrome; 2023 International Evidence-based Guideline for PCOS; Journal of Hepatology: HEC88473 in MASLD and type 2 diabetes.

04.06.2024                                                                                              

To apply for different types of peadiatric applications, such as PIP, starting from 4 June 2024, it is necessary to use the IRIS platform. IRIS is an online platform that securely handles regulatory and scientific procedures for pharmaceutical products. This platform should be used by any PIP applicant, even those not based in the European Union or without an authorized contact based in the EU. Before submission, it is necessary to request a research product identifier (RPI) through the IRIS system.

It is no longer necessary to send a letter of intent (LoI) to let EMA know about applicant’s intention to apply for a PIP.

It is possible to submit a single PIP for all corresponding marketing authorizations related to one medicinal product in case of a single applicant.

The list of paediatric submissions that can be done through IRIS is as follows:

• Initial Paediatric investigation plan (PIP)
• Updates to an approved PIP
• Waivers
• Check of compliance
• Annual reports on paediatric deferred measures
• Confirmation of applicability of a class waiver
• Discontinuation of a paediatric product development

An applicant may request from EMA a free of charge scientific advice on all appropriate tests and research studies to be conducted during a paediatric medicines’ development. This may also be done using the IRIS platform.

For innovative paediatric medicines applications, there is a pilot stepwise paediatric investigation plan (sPIP) programme that is applied in cases when there is limited crucial information available to outline certain parts of the PIP. This programme requires submission of a complete PIP as soon as necessary data becomes available.

Source: European Medicines Agency (EMA), summary by Nataliia Vietchinkina

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products.” FDA is issuing this guidance as part of its Real-World Evidence (RWE) Program for drugs and to satisfy, in part, the mandate under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to issue guidance about the use of RWE in regulatory decision making.

This guidance discusses the applicability of FDA’s investigational new drug application (IND) regulations to various clinical study designs that utilize real-world data (RWD) and clarifies the Agency’s expectations regarding clinical studies using RWD submitted to FDA in support of a regulatory decision regarding the effectiveness or safety of a drug that are not subject to the IND regulations.

This guidance finalizes the draft guidance of the same title issued on December 9, 2021.

Download a copy of the Guidance.

Source: the F.D.A.

PureTech is recruiting patients for the clinical trial of LYT-200 in patients with relapsed/refractory acute myeloid leukemia (AML), or with relapsed/refractory, high-risk myelodysplastic syndrome (MDS).

In Myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), immature blood cells are overproduced, leading to less mature blood cells.  This causes anaemia, with underlying increased risk for infection and bleeding (MD Anderson Cancer Center, 2023).  Chemotherapy, radiation and/or autologous treatments are among possible causes of MDS or AML in up to 10% of patients.

No available therapies can currently cure most of patients suffering from MDS and AML, which calls for urgent development of new medicines.

This  open-label, non-randomized, multi-center, phase 1, dose escalation study includes patients with AML relapsed/refractory to at least one line of prior therapy, with or without an allogeneic stem cell transplant, or in patients with a documented diagnosis of relapsed/refractory, high-risk myelodysplastic syndrome (MDS) post at least one line of treatment and for whom no standard therapy that may provide clinical benefit is available. 

The study commenced on December 12, 2022. The indicative completion of the clinical trial will be expected on May 1, 2025.

Among primary outcome measures are the Incidence of Treatment-Emergent Adverse Events [Safety and RP2D determination] and Evaluation of safety parameters including treatment emergent adverse events as detected by hematology, chemistry, coagulation safety labs, physical exams, vital signs, ECG, ECHO/MUGA, ECOG status.

The study will take place at several research sites in the United States: Baptist Health South Florida-Miami Cancer Institute, Miami; Cedars-Sinai Medical Center, Los Angeles; University of California Irvine Medical Center, Orange.

Among the inclusion criteria are

1. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2,

2. Patients are able and willing to comply with study procedures as per protocol, including bone marrowbiopsies,

3. Patients with a documented diagnosis of high-risk myelodysplastic syndrome (MDS), whose disease is relapsed/refractory, post at least one line of treatment based on the revised International Prognostic Scoring System (IPSS-R) and for whom no standard therapy that may provide clinical benefit is available and

4. Patients with morphologically documented primary or secondary AML by the World Health Organization(WHO) criteria, whose disease is relapsed/refractory to at least one line of prior therapy, with or without an allogeneic stem cell transplant and for whom no standard therapy that may provide clinical benefit is available or for patients who decline available standard of care can be enrolled into this research.

The page dedicated to this clinical trial that provides research sites contacts and more detailed information regarding the inclusion and the exclusion criteria can be found here: https://ichgcp.net/clinical-trials-registry/NCT05829226.

Cancer Research UK in collaboration with University of Manchester, University of Birmingham, Royal Marsden NHS Foundation Trust, and Hoffmann-La Roche are commencing recruitment into the clinical trial that is looking at a drug called entrectinib. The researchers plan that the study duration will be from April 2023 till October 2029.

Entrectinib is approved as standard of care treatment for adult patients with non-small cell lung cancer (NSCLC) which have a particular molecular alteration called ROS1-positive, and patients 12 years of age or older with solid tumours which have another type of change in the cancer cells.

This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. Investigators now wish to find out if it will be useful in treating patients with other cancer types which have the same molecular alteration (ROS1-positive).

If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future. This trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.

The study will take place at the several research sites around in the UK:

• Belfast City Hospital, Belfast, United Kingdom;
• University Hospital Birmingham, Birmingham, United Kingdom;
• Birmingham Children's Hospital, Birmingham, United Kingdom;
• Bristol Royal Hospital for Children, Bristol, United Kingdom;
• Bristol Haematology and Oncology Centre, Bristol, United Kingdom;
• Addenbrooke's Hospital, Cambridge, United Kingdom;
• Velindre Cancer Centre, Cardiff, United Kingdom;
• Western General Hospital, Edinburgh, United Kingdom;
• The Beatson Hospital, Glasgow, United Kingdom;
• Royal Hospital for Children Glasgow, Glasgow, United Kingdom;
• Leeds General Infirmary, Leeds, United Kingdom;
• Leicester Royal Infirmary, Leicester, United Kingdom;
• Alder Hey Hospital, Liverpool, United Kingdom;
• The Royal Marsden Hospital, London Borough of Sutton, United Kingdom;
• University College London Hospital, London, United Kingdom;
• Guy's Hospital, London, United Kingdom;
• Great Ormond Street Hospital, London, United Kingdom;
• Royal Manchester Children's Hospital, Manchester, United Kingdom;
• The Christie Hospital, Manchester, United Kingdom;
• Great North Children's Hospital, Newcastle, United Kingdom;
• Freeman Hospital, Newcastle, United Kingdom;
• Churchill Hospital, Oxford, United Kingdom;
• John Radcliffe Hospital, Oxford, United Kingdom;
• Weston Park Hospital, Sheffield, United Kingdom;
• Southampton General Hospital, Southampton, United Kingdom;
• Clatterbridge Cancer Centre, Wirral, United Kingdom.

The page dedicated to this clinical trial inclusion and exclusion criteria, as well as th esites' contacts can be found here: https://ichgcp.net/clinical-trials-registry/NCT05770544

This study will evaluate safety, tolerability, pharmacokinetic (PK) profile, and pharmacodynamic (PD) effects on GSBR-1290 in healthy overweight/obese volunteers (HOV). This study includes 3 planned cohorts. Participants will receive multiple-ascending doses of GSBR-1290 or Placebo from Day 1 to Day 28.

The clinical trial started in January 9, 2023 and will continue throughout September 21, 2023.

Incidence, severity and relationship of AE/SAE, vital signs, laboratory measures and ECG to assess safety and tolerability of multiple oral doses of GSBR-1290 in HOV.

Inclusion Criteria:

• Provided evidence of a signed consent.
• Age ≥ 18 and ≤ 75 years.
• Healthy overweight/obese adult men and women with body mass index ≥ 27. and ≤ 40 kg/m2.
• No nicotine use.
• Have a suitable venous access for blood sampling.

Exclusion Criteria:

1. History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic or neurological disease, including any acute illness or major surgery within the major 3 months
2. A sitting BP after resting for 5 minutes > 160mm Hg systolic or > 100 mm Hg diastolic or an apical pulse rate <50 or >100 beats per minute.
3. Evidence of abnormality on the screening visit ECG, or a history of known arrhythmia or prolonged QTcF pr prolonged QRS interval
4. Liver function test results elevated > 2.0-fold above the ULN for gamma gutamyl transferase, alkaline phosphatase, aspartate aminotransferase or alanine aminotransferase. Bilirubin above the ULN
5. Estimated glomerular filtration rate < 60mL/min/1.73 m2 body surface area
6. Known hypersensitivity to any of the study drug ingredients
7. Any other condition or prior therapy that would make the participant unsuitable for this study

The locations are the Anaheim Clinical Trials, Anaheim, California, United States; ProSciento, Inc, Chula Vista, California, United States; QPS Miami Research Associates, Miami, Florida, United States; Progressive Medical Research, Port Orange, Florida, United States. For contact details visit: https://ichgcp.net/clinical-trials-registry/NCT05762471

Areteia Therapeutics is commencing recruitment for the clinical trial of Dexpramipexole in adolescents and adults with severe eosinophilic asthma.

The trial officially began on the January 30, 2023 in several US research sites in California, Florida, Missouri, Oklahoma, and it is planned to complete by December 2025.

This study will assess the efficacy and safety of dexpramipexole as an adjunctive oral therapy in participants with inadequately controlled asthma with an eosinophilic phenotype and a history of asthma exacerbations.

The potential participants must be ≥12 years of age at randomization with documented physician diagnosis of asthma for ≥12 months. They must satisfy all the below (items a to c):

a). Participants who have received asthma controller medication with medium or high dose inhaled corticosteroids (ICS; ≥500 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per Global Initiative for Asthma (GINA) 2021) on a regular basis for at least 12 months prior to screening.

b). Documented treatment with a stable dose of either medium or high dose ICS for at least 3 months prior to Visit 1. The ICS may be contained within an ICS/LABA (long-acting β2 agonist) combination product. Daily oral corticosteroids are an allowed concomitant medication; participants on daily oral corticosteroids must be on a stable dose for 3 months before Screening Visit 1.

c) Use of one of more additional daily maintenance asthma controller medications according to standard practice of care is required. Use of a stable dose of any additional asthma controller medications must be documented for at least 3 months prior to screening.

For more detailed inclusion and exlcusion criteria, as well as for the research sites contact details, please visit: https://ichgcp.net/clinical-trials-registry/NCT05763121

DeuterOncology is recruiting patients for the clinical trial of Study to Determine the Safety and Pharmacokinetics of DO-2 in Patients With Advanced or Refractory Solid Tumours.

This study is a first-in-human, open-label, 2-part, Phase 1 dose escalation study of DO-2, administered orally to patients with advanced or refractory solid tumours, with MET aberrations, and no available, approved therapeutic alternative.

In Part 1, a Simon Design 3 accelerated titration design will be followed. One patient will be enrolled per cohort, until grade 2 toxicity is observed. Three sequential patients per cohort will be enrolled thereafter, with a minimum of 1 week between first dose administration in the first patient and the subsequent ones, in those latter cohorts.

The indicative duration of the clinical trial is from December 20, 2022 till June 2024.

Among primary outcome measures are the Determination of the Maximum Tolerated Dose (MTD) and The MTD in milligram is defined as the highest dose at which less than one third of the subjects in a dose level cohort experience DLT.

The study will take place at the Institut Roi Albert II - UC Louvain, Bruxelles, Belgium; UZA, Edegem, Belgium; Erasmus Medical Centre, Rotterdam, Netherlands.

Potential study participants must have:

• 18 years or older

• histologically or cytologically confirmed advanced or refractory solid tumour and no longer eligible for approved, available standard therapies. Tumour types must have:

  1. proven MET activating mutations, determined by previous next generation sequencing (NGS), whole exome sequencing (WES), whole transcriptome sequencing (WTS) or other genomic analysis methods, or
  2. proven amplification (≥ 10 copies) on archived tumour tissue. or
  3. Hereditary Renal Papillary Cancer
      
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• adequate bone marrow function, without the support of cytokines
• adequate liver function
• adequate renal function
• agree to follow the contraception requirements of the trial
• signed informed consent, indicating study patients understand the purpose of and procedures required for the study and are willing to participate in the study.

Whereas excluded from participation will be any patient who have any of the following:

• major surgery within 3 weeks before enrollment
• chemotherapy (in the case of nitrosoureas and mitomycin C within 6 weeks), radiotherapy, immunotherapy, or any other study drug within 3 weeks before study drug administration
• antibody based cancer therapy within 4 weeks before administration of the first dose of DO-2

• patients with brain metastases are excluded unless all of the following criteria are met:

  1. CNS lesions are asymptomatic and previously treated
  2. No ongoing requirement for corticosteroids as therapy for CNS metastases
  3. Imaging demonstrates stability of disease > 28 days from last treatment for CNS metastases
      
• leptomeningeal involvement (leptomeningeal carcinomatosis)
• history of uncontrolled heart disease including unstable angina, congestive heart failure, myocardial infarction within preceding 12 months, clinically significant rhythm or conduction abnormality, congenital long QT syndrome, obligate use of a cardiac pacemaker, QTc at screening greater than 450 milliseconds in males and greater than 470 milliseconds in females
• uncontrolled arterial hypertension despite appropriate therapy
• positive pregnancy test (urinary beta-hCG) at screening (applicable to women of child-bearing potential who are sexually active)
• mental status alteration or history of major psychiatric illness, which may potentially impair patient's compliance with study procedures
• signs and symptoms of active infection requiring systemic therapy
• other medical condition (e.g. pre-existing kidney dysfunction) that in the opinion of the investigator makes it undesirable for a patient to participate

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05752552

The company Arecor Limited is commencing recruitment for the clinical trial of the AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study. The location is Austria.

The trial officially began on the February 17, 2023 and is planned to complete on November 25, 2023.

This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.

The population that can be enrolled into this study includes:

• Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening 
• Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening.
• BMI within the range of 25 - 45 kg/m2 (both inclusive)
  
  Exclusion Criteria:
  - Known or suspected hypersensitivity to IMPs or related products
  - Clinically significant concomitant disease or abnormal lab values
  - Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05754424

The company Hong Kong Children's Hospital is enrolling patients into the clinical trial investigating Quadruple Immunotherapy for Neuroblastoma.

This is a single-arm clinical trial to evaluate the efficacy and safety of quadruple immunotherapy with natural killer (NK) cells, anti-GD2 antibody, cytokines (interleukin-2 (IL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF)) and retinoid X receptor gamma (RXRg) agonist spironolactone for paediatric patients with relapsed or refractory neuroblastoma.

The trial is designed to enroll male and female 18 Years and younger and is being conducted in the Hong Kong Children's Hospital. The study started on January 1, 2022.

The patients that can be enrolled into this study include:

• relapsed or refractory neuroblastoma
• Adequate organ function: creatinine clearance ≥40 ml/min/1.73m2, total bilirubin ≤3 times upper limit of normal and ALT ≤500 IU/L, left ventricular shortening fraction ≥25%, and oxygen saturation ≥92% in room air
• Karnofsky or Lansky performance status score ≥50
• Has an appropriate HLA-haploidentical NK-cell donor available.
  
  Exclusion Criteria:
  
  - Pregnant or lactating woman
  - HIV infection
  - Patients for whom conventional treatment is deemed more appropriate
  - Patients who are unlikely to benefit, e.g., terminal malignancy with life expectancy <1 month.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05754684

The research company EDAP TMS S.A is conducting the clinical trial Evaluation of the Efficacy of HIFU Treatment on Rectal Endometriosis Symptoms (ENDO-HIFU-R2).

Rectal endometriosis (RE) induces lesions associated with painful symptoms that can alter quality of life. High Intensity Focused Ultrasound (HIFU) is a non-invasive ablative procedure using a high-intensity ultrasound probe to induce tissue devitalization using acoustic cavitation and thermal ablation. Focal One® is a transrectal HIFU device, which is validated to treat prostatic cancer. In this comparative, randomized, double blind study , the primary objective is to evaluate the efficacy of the HIFU treatment of rectal endometriosis with Focal One® HIFU device on the Acute Pelvic Pain 3 months after HIFU treatment, in comparison to a Sham group.

It is planned to include 60 participants.

Actual study start date is February 3, 2023. The researchers expect to complete the study by February 1, 2024.

Inclusion criteria:

• Patient 18 years of age or older,
• Rectal endometriosis on preoperative imaging with no other digestive location,
• Symptomatic patient (Acute pelvic pain > 3), in failure of drug treatment,
• Endometriotic lesion visible on ultrasound and confirmed on MRI,
• Centralized MRI, reviewed and validated by the MRI review committee,
• No current pregnancy and no pregnancy plan during the study period,
• Patient agreeing not to change her hormonal treatment throughout the study period,
• Patient accepting the constraints of follow-up defined in the framework of the study,
• Patient affiliated to French health insurance.

Exclusion Criteria:

• Ongoing urogenital infection,
• Anorectal anatomy incompatible with HIFU treatment,
• Overall pain level considered intolerable by the patient and making a potential 3-months delay management impossible,
• History of segmental rectal resection or discoid resection,
• Patient with an implant located less than 1 cm from the treatment area,
• Inflammatory disease of the colon,
• Allergy to latex,
• No scheduled endometriosis procedures during study follow-up,
• Treatment of endometriosis in the context of pregnancy desire for which a 3-month delay is not appropriate
• Patient with contraindications to MRI,
• Patient who has already received HIFU treatment for a rectal endometriotic lesion,
• Patient who does not speak or read French,
• Patient deprived of liberty following a judicial or administrative decision,
• Patient in labor or nursing,
• Patient under guardianship or curatorship.

The study will take place in several research sites in the following locations: Aix-en-Provence, France; Angers, France; Bordeaux, France; Clermont-Ferrand, France; Le Kremlin-Bicêtre, France; Lille, France; Lyon, France; Paris, France; Strasbourg, France. For more details please visit: https://ichgcp.net/clinical-trials-registry/NCT05755958

The company Northwell Health is enrolling patients into the clinical trial investigating Changes in Penile Firmness With Low-Intensity Shockwave Therapy (LiST).

Patients presenting with erectile dysfunction are often found to have increased corporal firmness on elastography. We hypothesize that this corporal firmness reflects reversable changes that can be altered by Low-Intensity Shockwave Therapy (LiST). In this pilot study patients found to have increased corporal firmness will be treated with LiST.

The study is being done to find out if low-intensity shockwave therapy can improve penile blood flow and restore sexual function in men with impaired erectile function.

The trial is designed to enroll Male 18 Years to 64 Years and is being conducted in the Dr. Gilbert's Office, Great Neck, New York, United States; The Smith Institute for Urology, Lake Success, New York, United States.

The study start date is March 5, 2023.

Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Men aged 18-64 4. Sexually active men and evidence of increased firmness on elastography during their standard evaluation for erectile dysfunction.

Exclusion Criteria: 1. Within two weeks of Visit 1 using erectogenic medications including PDE5 inhibitors and/or penile injection therapy 2. Presence of a penile implant. 3. Presence of cardiac pacemaker or defibrillator 4. Patients who are using devices which are sensitive to electromagnetic radiation. 5. Screening ultrasound positive for testicular cancer 6. Presence of untreated prostate cancer 7. Patients with severe coagulation disorders 8. Patient that in the opinion of the Principal Investigator would be non-compliant with the study

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05756803

Aelis Farma is starting a new clinical trial of Phase 1/2 Trial of AEF0217 in Participants With Down Syndrome.

AEF0217-102 clinical trial assesses the safety, tolerability, plasma exposure and preliminary indications of pharmacodynamic activity of AEF0217 in female and male adult participants with Down syndrome between 18 and 35 years old. The trial AEF0217-102 is a double-blind, randomized, placebo-controlled, multiple-dose, 4-week phase 1/2 study. After a screening period, the participant will be randomised and will take an oral dose of AEF0217 0.2mg or placebo once a day for 28 days.

The clinical trial started in December 15, 2022 and will continue throughout June 2023.

The population that can be included into this trial is:

• Male or female of age ≥18 to ≤35 years, with weight ≥50 to ≤90 kg., with BMI ≥18.5 to ≤30 kg/m2, and having clinical diagnosis of Down syndrome (full trisomy 21 and translocations) documented by chromosomal analysis (karyotyping). Participants must understand and accept the trial procedures, shall be independently mobile and have sufficient vision and hearing to participate in the trial evaluations. 
• Clinical Evaluation of Language Fundamentals Preschool-2 (CELF Preschool-2) test score ≥7.
•  IQ >40 measured with the Kaufman Brief Intelligence Test (KBIT).
• Must have a parent or other reliable caregiver who agrees to accompany the participant to all clinic visits and be available for a telephone visit, provide information about the participant as required by the protocol, and ensure compliance with the medication schedule and protocol requirements.
• Vital signs, electrocardiogram (ECG), and safety laboratory parameters must be within normal ranges or without clinically relevant abnormalities except for: 1. Stable type 1 or type 2 diabetes, i.e., HbA1c level ≤6.5%, provided participants are monitored regularly prior to and during the trial to ensure adequate glucose control. 2. Hypothyroidism provided participants are euthyroid and stable on treatment for at least 6 weeks prior to screening.
  
  Excluded will be any patient with any of the following symptoms/states:
  - Pregnant or nursing female.
  - Mosaic Down syndrome.
  - Active or clinically relevant conditions that could, in the investigator's judgment, affect absorption, distribution, or metabolism of the trial intervention (e.g., inflammatory bowel disease, gastric or duodenal ulcers).
  - Clinically relevant obstructive pulmonary disease or asthma that is untreated or not controlled by treatment within 6 weeks of screening or being treated with oral steroids.
  - Severe obstructive sleep apnea. - Recent (≤1 year) or ongoing hematologic or oncologic disorders (mild anemia is allowed).
  - Personal history of infantile spasms/convulsions/epilepsy, severe head trauma, or CNS infections (e.g., meningitis), except for a single isolated febrile seizure.
  - Clinically relevant unstable gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease.
  - Current Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis including autism spectrum disorder or any primary psychiatric diagnosis.
  - Treatment with medication known to induce CYP3A4/5 P450 isozymes. - Intake of vitamin supplements, catechins, or products containing epigallocatechin gallate (EGCG) (e.g., TEAVIGO, Mega Green Tea Capsules Life Extension, or Font-UP Grand Fontaine Laboratories) currently or during the 3 months prior to the screening visit.
  - Symptoms of early dementia as assessed by the National Task Group-Early Detection Screen for Dementia (NTG-EDSD).
  - Disclosure of drug or alcohol abuse during medical interview/anamnesis at screening and/or positive urine test for alcohol or drugs of abuse at screening or/and baseline.
  - Epileptiform abnormalities (excluding isolated sharp waves and beyond those expected for age) in the screening EEG performed over 10 minutes with concurrent video recording and evaluated by an expert. - Participants with a history of suicide attempt or deliberate self-harm due to suicidal ideation. Suicidal ideation (even in the absence of suicide attempt or deliberate self-harm) during the 12 months prior to screening. Assessed by 3 specific questions on suicidal ideation, suicidal behavior, and any self-injurious behavior.
  - Known hypersensitivity to any drug.
  - Participants with clinically significant illness from 2 weeks prior to screening until Day -1.
  - Covid-19 positive PCR test and symptoms within the last 10 days prior to Day -1.
  - History of or current life-threatening disease.
  - Any other clinically relevant concomitant disease or condition or finding at screening that in the investigator's judgment could jeopardize the participant's safety or interfere with, or the treatment thereof might interfere with, the conduct of the trial and related procedures and/or might bias interpretation of the trial results.

The study location is the Hospital del Mar Medical Research Institute (IMIM), Barcelona, Catalonia, Spain. For more details: https://ichgcp.net/clinical-trials-registry/NCT05748405

The company Areteia Therapeutics is commencing recruitment for the clinical trial of the A 24-week Clinical Trial to Study the Effect of Dexpramipexole in Adolescents and Adults With Eosinophilic Asthma.

The trial that takes place in several serearch sites in the USA officially began on the January 30, 2023 and is planned to complete on July 2024.

The purpose of this study is to evaluate dexpramipexole as an add-on oral therapy in participants with inadequately controlled eosinophilic asthma to evaluate improvements in lung function, asthma control, and quality of life. In addition, the study will further evaluate the safety and tolerability of dexpramipexole in participants with eosinophilic asthma.

The population that can be enrolled into this study includes: 

1. Male or female ≥12 years of age at randomization who signed a written infromed consent to participate.

   Asthma-related criteria

2. Documented physician diagnosis of asthma for ≥12 months.
3. Participants requiring at a minimum daily low dose inhaled corticosteroids (ICS; ≥100 μg/day fluticasone propionate dry powder formulation daily or clinically comparable, per GINA 2021), plus one or more additional daily maintenance asthma controller medications, eg, long-acting β2 agonist (LABA), leukotriene antagonist, theophylline, long-acting muscarinic antagonists, cromolyn/nedocromil. Use of daily ICS must be for at least 12 weeks prior to Screening Visit 1 and the doses of all controller medications must be stable for at least 4 weeks prior to Screening Visit 1.
4. Pre-BD FEV1 ≥40% and <80% of predicted at Screening.
5. Bronchodilator reversibility, as evidenced by ≥12% and ≥200 mL improvement in FEV1, 15 to 30 minutes following inhalation of 400 μg (four puffs) of albuterol/salbutamol (≥12% and ≥160 mL for ages 12 to 17).Participants who do not meet the bronchodilator reversibility inclusion criterion but have ≥10% and ≥160 mL reversibility, may repeat the reversibility spirometry assessment once during the Screening Period, at an unscheduled visit at least 7 days prior to baseline.
6. ACQ-6 ≥1.5 at Screening.
7. Eosinophil count of ≥0.30x10⁹/L at Screening Visit 1. If the initial value is between 0.250x10⁹/L to 0.299x10⁹/L, then this may be repeated once at an unscheduled visit (prior to Screening Visit 2).
8. Negative urine pregnancy test for women of childbearing potential (WOCBP; after menarche) at Screening and Baseline.

For exclusion criteria and research sites contact details kindly follow the link: https://ichgcp.net/clinical-trials-registry/NCT05748600

The company NIZO Food Research in cooperation with Kappa Bioscience AS  is commencing recruitment for the clinical trial of the Antioxidant and Immune Effects of Vitamin K2. 

The conditions are Oxidative Stress, Inflammation. A new clinical trial is recruiting patients in the Netherlands. The trial officially began on the November 15, 2022 and is planned to complete on May 2023.

The aim of the study is to obtain insight into a dose-dependent effect of vitamin K2 on oxidative stress and specific markers of the immune system.

The population that can be enrolled into this study includes:

• Self-reported postmenopausal (at least one year after the final menstruation) - BMI ≥25 and ≤32 kg/m2;
• Plasma dp-ucMGP concentration in highest 50-66% of the screened population;
• Non-smoking, defined as not smoking currently and not having smoked (at all) in the year before study start;
• Healthy as assessed by the health questionnaire and according to the judgment of the study physician;
• Voluntary participation;
• Having given written informed consent;
• Willing to comply with study procedures.
  
  Exclusion Criteria:
  - Plasma dp-ucMGP concentration >1000 pmol/L at screening
  - Treatment with oral antibiotics within 2 months of the start of the study
  - Any vaccination in the month before study start or any scheduled vaccination during the study period
  - Use of antioxidant or vitamin K and D supplements in the month before the start of the study;
  - Use of aspirin or medication with established antioxidant or anti-inflammatory properties;
  - Use of medication that interferes with vitamin K or blood coagulation; - Use of statins to reduce level of low-density lipoprotein cholesterol in the blood;
  - Hyperlipidaemia, diabetes, hypertension, intestinal disease, diseases with an inflammation component;
  - Hormone replacement therapy in women;
  - Follow a vegetarian or vegan diet;
  - Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before day 1 of this study;
  - Alcohol consumption for men >28 units/week and >4/day; for women: >21 units/week and >3/day;
  - Reported unexpected weight loss or weight gain of >3 kg in the month prior to pre-study screening, or intention to lose weight during the study period;
  - Reported slimming or medically prescribed diet;
  - Recent blood donation (<1 month prior to Day 01 of the study); - Not willing to give up blood donation during the study.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05675163.

The company OM Pharma is commencing recruitment for the clinical trial of the OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness. This is a randomised, placebo-controlled, 3-Arm, double-blind, multicentre, phase 4 Study to Assess the Efficacy of OM-85 (Broncho-Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years With Wheezing Lower Respiratory Illness.

The conditions include respiratory tract infections and wheezing lower respiratory illness. The trial officially began on the December 12, 2022 and is planned to complete by June 30, 2025.

This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years.

The population that can be enrolled into this study:

• Children of either gender aged between 6 months and 5 years, inclusive.
• For children ≥1 year of age, ≥4 RTIs (as reported by parents or LAR of subject), including ≥2 episodes of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 12 months prior to enrolment. OR
• For children  <1 year of age, ≥2 RTIs (as reported by parents or LAR of subject), including ≥1 episode of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 6 months prior to enrolment.
• Parents or LAR of subject have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.
  
  The following patients cannot participate:
• With anatomic alterations of the respiratory tract.
• With other respiratory chronic diseases (e.g., tuberculosis, cystic fibrosis).
• With any autoimmune disease.
• Those having HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).
• With congenital heart disease.
• With haematologic diseases.
• With liver or kidney failure.
• New-borns before 34 weeks of gestational age.
• With malnutrition as per World Health Organization (WHO) definition.
• With any known neoplasia or malignancy.
• Undergoing treatment with the following medications:
  1. Systemic or oral steroids (e.g., oral prednisolone) within 4 weeks prior to study enrolment.
  2. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.
• With previous use within last 6 months of enrolment or ongoing use of bacterial lysates.
• Underwent any major surgery within the last 3 months prior to study enrolment.
• Having known allergy or previous intolerance to investigational medicinal products (IMP).
• Having any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.
• Whsose other household members have previously been randomised in this clinical study.
• Whose families expected to relocate out of study area within 24 months of the initiation of the study.
• Being currently enrolled in or has completed any other investigational device or drug study or receiving other investigational agent(s) within  <30 days 30 days prior to screening.
• With parents or legally acceptable representative (LAR) who do not have access to internet connection.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05677763.

Lo.Li.Pharma s.r.l is recruiting patients for the clinical trial of Inositol Treatment in Different Type of PCOS Phenotype.

Evaluation of the efficacy of inositol treatment in women with PCOS in relation to the phenotype (according to the Rotterdam Criteria)

The study start was in December 2022. The indicative completion of the clinical trial will be expected in May 2023.

Among primary outcome measures are the regularization of the menstrual cycle and number of women with regular/altered menstrual cycle.

The study will take place at the Clinica Alma Res, Roma, Italy.

Included will be women with PCOS of any phenotype. The patients receiving hormonal treatment (such as contraceptive pill), or who use supplements containing myo-inositol, or with severe co-morbidities cannot be enrolled into this research.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05678114

The company Clairvoyant Therapeutics is enrolling patients into the clinical trial investigating Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD).

The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question[s] it aims to answer are: - Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy? - Is treatment with psilocybin and therapy safe for participants? Participants will - Attend 13 study visits - Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo - Record their daily alcohol consumption on study specific device Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.

The trial is designed to enroll male and female 18 Years to 70 Years and is being conducted in the Sabi Mind, Calgary, Alberta, Canada; Okanagan Clinical Trials, Kelowna, British Columbia, Canada.

The study start date is November 2, 2022.

The patients that can be enrolled into this study include:

• Moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator.
• Expressed a wish to reduce or stop alcohol consumption. 
• Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.
  
  Exclusion Criteria: 
• Diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic episode.
• Recent (within last 12 months) diagnosis of a major depressive disorder (MDD) (HAM-D score >19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder, or eating disorders.
• Subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session.
• History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05646303.

National Cancer Center Hospital East is starting a new clinical trial of Total Neoadjuvant Therapy of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer (ENSEMBLE).

This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.

Total neoadjuvant therapy (TNT) for locally advanced rectal cancer (LARC) has the promise, which means non-operative management (NOM) enable more patients (pts) with a complete clinical response (cCR) or near-complete clinical responses (nCR) after TNT to avoid subsequent radical surgery, with potentially maintaining anorectal function and quality of life (QoL).

The aim of this randomized phase III trial is to test superiority of consolidation irinotecan, capecitabine and oxaliplatin (CAPOXIRI) vs. capecitabine and oxaliplatin (CAPOX) following SCRT as TNT in pts with LARC. Pts in both groups will be re-staged after completing TNT before radical surgery according to the Memorial Sloan Kettering Regression Schema; pts with incomplete response (iCR) will undergo total mesorectal excision (TME), cCR pts will receive NOM, and nCR pts will undergo TME or NOM by a physician discretion under the recommendation of blind assessment by the designated NOM central committee. Pts will be followed by CT, MRI, colonoscopy and liquid biopsy every 4 months for 2 years, and every 6 months thereafter up to 5 years. To detect a decrease in 3-year cumulative probability of organ preservation-adapted Disease free survival (DFS) from 75.0% to 81.7%, corresponding to a target hazard ratio of 0·70, a total of 608 pts (196 events) would achieve 70% power at a two-sided α significance level of 0.05.

The clinical trial started in November 21, 2022 and will continue throughout December 31, 2030.

For more details: https://ichgcp.net/clinical-trials-registry/NCT05646511.

The company 4D Molecular Therapeutics is enrolling patients into the clinical trial investigating 4D-310 in Adults With Fabry Disease and Cardiac Involvement.

This is a prospective multicenter, open-label, dose-escalation trial to assess the safety, tolerability, and pharmacodynamics of 4D-310 following a single IV administration. The study population is comprised of adult males and females with Fabry Disease and cardiac involvement

The trial is designed to enroll male and female 18 Years and older and is being conducted in the Royal Melbourne Hospital, Melbourne, Australia; Royal Perth Hospital, Perth, Australia; Taipei Veterans General Hospital, Taipei, Taiwan. The study started in October, 2022.

Included can be adult males and females with athogenic GLA mutation consistent with Fabry Disease; with confirmed diagnosis of classic or late-onset Fabry disease with cardiac involvement; individuals on ERT must be on a stable dose for at least 6 months (and a minimum of 12 months total exposure) prior to study enrollment; must agree to use highly effective contraception. 

Whereas the following population cannot be enrolled into this study: patients with presence of high titer neutralizing antibody to 4D-310 capsid, or presence of high antibody titer to AGA 2. eGFR <45 mL/min/1.73 m2; undergone kidney transplantation or currently on hemodialysis or peritoneal dialysis; have the diagnised HIV, active or chronic hepatitis B or C; with evidence of liver disease, severe pulmonary disease or diabetes with poor glycemic control; with history of stroke or transient ischemic attack within the last 12 months, or other significant thromboembolic disease history (e.g. pulmonary embolism); have contraindication to systemic corticosteroid therapy or immunosuppressive therapy; with chronic steroid use, defined as ≥ 3 months of oral corticosteroid use within the last 12 months; have moderately severe to severe cardiovascular disease or uncontrolled hypertension; have left ventricular ejection fraction of <45% on echocardiogram (ECHO); are currently receiving investigational drug, device or therapy or having ever received gene therapy; have history of infusion related response to ERT or any adverse reaction leading to ERT discontinuation; with history of cancer within 2 years (exceptions include non-melanoma skin cancer, localized prostate cancer treated with curative intent); are pregnant or breast-feeding.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05629559

Sanofi is recruiting patients for the clinical trial of A Study to Evaluate the Effect of SAR443820 on Serum Neurofilament Levels in Male and Female Adult Participants With Multiple Sclerosis.

This is a Phase 2, randomized, double-blind, placebo-controlled 2 parallel-arm study to assess the effect on serum neurofilament light chain (sNfL), safety and tolerability of oral SAR443820 compared to placebo in male and female participants aged 18 to 60 years with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) (relapsing or non-relapsing), or primary progressive multiple sclerosis (PPMS) followed by an open-label long-term extension period. The total study duration is approximately 100 weeks and includes the following: 4-week screening period 48-week double-blind treatment period (Part A) 48-week open-label long-term extension period (Part B)

The indicative completion of the clinical trial will be expected in August, 2025. The study will take place at the Investigational Site Number: 3800001, Pozzilli, Isernia, Italy.

Enrolled will be the adult patients up to 60 years (inclusive) of age, with diagnosis of RRMS, SPMS (relapsing or non-relapsing) or primary progressive subtype according to the 2017 revision of the McDonald diagnostic criteria (SPMS diagnostic criteria according to initial relapsing remitting disease course followed by progression with or without occasional relapses, minor remissions, and plateaus; progression denotes the continuous worsening of neurological impairment over at least 6 months). Participants with Expanded Disability Status Scale (EDSS) score of 26 inclusive at screening. Participants who are either untreated or in the opinion of the Investigator are stable on an allowed disease-modifying therapy (DMT) (interferons, glatiramer acetate, fumarates, or teriflunomide) for at least the past 3 months, AND not anticipated to require a change in multiple sclerosis (MS) treatment for the duration of Part A and Part B (through Week 96); in Part B changes in dose of allowed DMTs or transition to other allowed DMTs is permitted). Participants with body weight at least 45 kg and body mass index (BMI) at least 18.0 kg/m^2. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

The exclusion criteria and the contact details may be found here: https://ichgcp.net/clinical-trials-registry/NCT05630547.

CuraLife is starting a new clinical trial of Evaluation of Efficacy and Safety of Curalin As Add-On Therapy in Adults With Type 2 Diabetes Mellitus.

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Curalin As Add-On Therapy in Adults with Type 2 Diabetes Mellitus.

The clinical trial started in October 15, 2021 and will continue throughout June 30, 2023. The locations are the Soroka Medical Center, Be'er Sheva, Israel; Lin Medical Center, Haifa, Israel; Herzelia Diebetes Center, Herzliya, Israel; Ichilov Medical Center, Tel Aviv, Israel.

For the inclusion and exclusion criteria please follow the link: https://ichgcp.net/clinical-trials-registry/NCT05631431.

Danish Headache Center is recruiting patients for the clinical trial of Migraine Induction Properties of PACAP-38 After Eptinezumab in Migraine Without Aura Patients.

To investigate whether administration of calcitonin gene-related peptide (CGRP) binding monoclonal antibodies eptinezumab prevents pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) induced migraine attacks in migraine without aura patients.

The aim of the present study is to investigate whether - CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in migraine without aura patients. Clinical and basic research have established calcitonin gene-related peptide (CGRP) as central molecule in migraine pathophysiology, yet existing CGRP antagonizing therapies such as the CGRP and CGRP receptor binding monoclonal antibodies are only effective in 50-60% of migraine patients. PACAP-38 and CGRP colocalize in the trigeminovascular system, and both activate adenylate cyclase upon receptor binding which causes increased formation of cyclic AMP (cAMP). It is unknown if CGRP and PACAP-38 signaling pathways differ sufficiently for PACAP-38 to be an alternative treatment target to CGRP. Whether administration of CGRP binding monoclonal antibodies eptinezumab prevents PACAP-38 induced migraine attacks in migraine without aura patients is yet to be investigated.

The study starts in December 2022 at the Danish headache center, Glostrup, Denmark. The indicative completion of the clinical trial will be expected in July 30, 2023.

The following population may be enrolled into this study: healthy volunteers of both sexes from 18 to 60 years, of 50 to 100 kg, with the history of migraine without aura for ≥ 12 months according to the International Classification of Headache Disorders 3rd Edition (ICHD-3) criteria and with no migraine preventive treatment. Women of childbearing potential must use adequate contraception.

Excluded will be those havong a history of serious somatic disease; having more than 50 years of age at migraine onset; history of any other primary headaches disorder (except ≤ 5 monthly days with tension- type headache); with daily intake of any medication except contraceptives can be enrolled into this research.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT05634161.

Istituto Nazionale di Ricovero e Cura per Anziani is enrolling patients into the clinical trial investigating Psycho-social Intervention With Paro Robotic Seal Focused on Patients With Dementia (PARO).

The overall objective of the study is to evaluate the improvement in patient-perceived quality of life following the use of the Paro robot integrated with traditional intervention in the elderly with dementia.

PARO is an advanced interactive robot. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties. PARO has five kinds of sensors: tactile, light, audition, temperature, and posture sensors, with which it can perceive people and its environment. PARO can learn to behave in a way that the user prefers, and to respond to its new name.

The trial is designed to enroll male and female 65 Years and older and is being conducted in the IRCCS INRCA Hospital, Ancona, Italy, and it started on October 1, 2022.

The patients that can be enrolled into this study include must have the diagnosis of mild-moderate dementia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM V) with MMSE between 10 and 24. They must be attending the Alzheimer's Day Center since at least 3 months and have a caregiver.

Between the exclusion Criteria are severe sensory disabilities (visual and auditory), comprehension difficulties, history of syncopal episodes, epilepsy, and dizziness not controlled pharmacologically, severe autonomic system dysfunction, severe behavioral syndromes not compensated by medication.

This page provides a more detailed overview of this clinical trial:https://ichgcp.net/clinical-trials-registry/NCT01633268

The company Salubris Biotherapeutics Inc is commencing recruitment for the clinical trial of JK08, an IL-15 Antibody Fusion Protein Targeting CTLA-4, in Patients With Unresectable Locally Advanced or Metastatic Cancer (solid tumor, advanced solid tumor, metastatic cancer, melanoma, colorectal cancer, breast cancer). The study takes place in Belgium.

The trial officially began on the October 17, 2022 and is planned to complete on February 20, 2026. 

This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study.

The population that can be enrolled into this study includes:

- Non-small cell lung cancer (NSCLC). - Small cell lung cancer (SCLC). - Melanoma. - Clear cell or papillary renal cell carcinoma (RCC). - Urothelial cancer (UC). - Head and neck squamous cell cancer (HNSCC). - Luminal B (ER+, PR-, any HER2 status) or triple-negative breast cancer. - Gastric or gastro esophageal adenocarcinoma (GC/GEJ). - Esophageal squamous cell cancer. - Skin squamous cell carcinoma (SCC). - Pancreatic adenocarcinoma. - Hepatocellular carcinoma (Childs-Pugh A or B7 only). - Colorectal adenocarcinoma (CRC). - Epithelial ovarian cancer. - Cervical cancer. - Endometrial adenocarcinoma. - Thyroid cancer (follicular or papillary). For the escalation cohorts, patients must have experienced progressive disease on or be intolerant to an established standard systemic anti-cancer therapy for a given tumor type or have been intolerant to such therapy, or in the opinion of the Investigator have been considered ineligible for a particular form of standard therapy on medical grounds. Patients must have no available proven curative or life prolonging therapies. 

For the detailed inclusion and exclusion criteria, as well as to see the site location and address, please see the study profile: https://ichgcp.net/clinical-trials-registry/NCT05620134.

The research company Acrotech Biopharma Inc is conducting a Phase 3 Double Blind multi-center study conducted at 40 US investigational sites to assess the efficacy and safety of Difamilast Ointment 1% in subjects ≥2 years of age with mild to moderate atopic dermatitis.

The study sites are enrolling at multiple locations in the USA. It is planned to include 336 participants.

Actual study start date is October 1, 2022. The researchers expect to complete the study by December 30, 2023.

One primary outcome measure is To evaluate the efficacy of twice-daily topical application of difamilast ointment 1% compared to vehicle control in subjects ≥2 years of age with mild to moderate AD, The proportion of subjects achieving success on the the 5-point IGA of AD Severity score at Day 29, and the success is defined as as a score of Clear (0) or Almost clear (1), with at least a 2-grade improvement from Baseline on the 5-point IGA of AD Severity score at Day 29, who have no use of prohibited medication, and who do not discontinue treatment due to related AE or lack of efficacy.

The location of the study can be found here: https://ichgcp.net/clinical-trials-registry/NCT05608343.

University of Kansas Medical Center is starting a new clinical trial of Itraconazole to Prevent Recurrent Barrett's Esophagus.

Recurrent Barrett's esophagus (BE) that occurs at the rate of 12.4%/year is the Achilles heel of the endoscopic treatment of high-risk BE. Over time, after eradication, BE ultimately recurs in as many as 30-50% of the patients putting them at risk for esophageal adenocarcinoma (EAC), thereby undoing the benefits of an effective initial therapy.

Also, recurrences need retreatments that increase costs and complications including strictures and refractory ulcerations. A therapy to prevent recurrent BE does not currently exist. Itraconazole with its ability to inhibit important molecular pathways related to BE development could enhance the long-term effectiveness of endoscopic eradication of high-risk BE, thereby promoting a long-term cure

The clinical trial started on September 14, 2022 and will continue throughout December 2023.

Itraconazole drug and blood levels will be primary outcome measure. The primary endpoint will be the tissue (in esophageal biopsies) and blood concentrations of itraconazole.

Participants must have Barrett's esophagus with either confirmed low-grade dysplasia or high grade dysplasia or intramucosal/T1 adenocarcinoma (see histologic review) being considered for endoscopic treatment. Besides, patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Excluded from participation are any patients who are unable to provide informed consent, those with: New York Heart Association class III or IV congestive heart failure (CHF), liver function tests (LFT)>3X upper limit of normal, drug allergy to itraconazole, pregnancy, prolonged QTc (>450 ms for men and QTc>470 ms for women) or critical drug interactions with other medications metabolized by cytochrome P450(CYP)3A4.

The contacts and locations are the University of Kansas Medical Center, Kansas City, Kansas, United States. For more details: https://ichgcp.net/clinical-trials-registry/NCT05609253.

Vera Therapeutics, Inc is starting a new clinical trial of Atacicept in Subjects With Active Lupus Nephritis (COMPASS).

The objective of the study is to evaluate the effect of atacicept compared to placebo on changes to renal response in adult subjects with LN.

The study will assess atacicept vs. placebo on the impact of renal function. Safety and patient reported outcomes will be clinically assessed. The clinical study is comprised of a 104 week double-blind treatment period, followed by a 52 week open-label treatment period and a 26 week safety follow-up period.

The clinical trial started on November 2, 2022 and will continue throughout December 15, 2028.

The patients that can participate include adult male or female able to understand,sign and date a written informed consent form, with the diagnosis of SLE 4. Biopsy- Proven Active LN 5. that requires high-dose corticosteroids and immunosuppressive therapy for the treatment of active LN 6. Besides, subject must be willing to take oral MMF for the duration of the study.

Whereas excluded will be any patient with eGFR of ≤30 mL/min/1.73 m2; having sclerosis in 50% of glomeruli on renal biopsy; with evidence of rapidly progressive glomerulonephritis; those currently requiring renal dialysis or expected to require dialysis during the study; having serum igG <7 g/L 6; having active infection or at high infectious risk.

The locations of the Vera Sites are: Alabama, United States; California, United States; Connecticut, United States; Florida, United States; Georgia, United States; Illinois, United States; Las Vegas, Nevada, United States; New Jersey, United States; New York, United States; Ohio, United States; Tennessee, United States; Texas, United States; Puerto Rico; Spain.

For more details: https://ichgcp.net/clinical-trials-registry/NCT05609812.

The company Advanced BioDesign is commencing recruitment for the clinical trial of ABD-3001 in Refractory or Relapsed AML and High Risk MDS Adult Patients.

The conditions are Acute Myeloid Leukemia, Adult, Myelodysplastic Syndromes. The trial officially began in France in October 2022 and is planned to complete by December 2024.

This First In Human (FIH) study is a prospective, open-label, multicenter, Phase 1 study, with a dose escalation design, followed by an optimized design. It will consist in a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part followed by a "Regimen optimization" part with an extension cohort.

The population that can be enrolled into this study includes patients with relapsed/refractory Acute Myeloid Leukemia (AML) after failing at least one therapy regimen and a salvage treatment or are not eligible for salvage treatment regimens including targeted therapy; patients with relapsed/refractory Myelodysplastic syndrome (MDS) ineligible for salvage treatment who are diagnosed high-risk and very high-risk using Revised International Prognostic Scoring System (IPSS-R) prognostic risk categorization; patients not eligible to alloSCT; all female patients must have negative blood or serum/urine pregnancy test.

Excluded are any patients with acute myeloid leukemia (AML) with Inv(16) MYH11-CBF or t(8;21) AML-ETO RUNX1-RUNX1 or (PML/RARA) karyotype abnormalities and eligible to targeted therapies; participants with clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia; being on ongoing immunosuppressive treatment; having hematopoietic stem cell transplantation (HSCT) performed within 3 months prior to study Visit 1; having life-threatening illnesses other than the studied one, with uncontrolled medical conditions or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety or interfere with the patient's ability to comply with the study activities; patients on anti-tumor therapy within 14 days of study Visit 1 or with the history of prior participation in an interventional investigational clinical study (drug or medical device) within 21 days of study Visit 1; patients who underwent radiotherapy within 28 days prior to study Visit 1; having history of other malignancy in the last 12 months prior to study Visit; with other active solid tumor; patients taking medications that are known to prolong the QT interval; underwent major surgery within 4 weeks prior to study Visit 1 (Day 1, start of study therapy); having any condition deemed by the investigator to be likely to interfere with a subject's ability to participate in the clinical trial.

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05601726.

Beni-Suef University is enrolling patients into the clinical trial investigating Growth Hormone For Poor Ovarian Reserve Patients in ICSI Trials.

The trial is designed to enroll Female 20 Years to 40 Years and is being conducted in the Beni-suef university, Banī Suwayf, Beni Suef, Egypt.

The study start date is February 1, 2022, and it is planned to enroll 120 participants.

The patients that have antral follicle count (AFC)<7 or - anti-Müllerian hormone (AMH)<1.1ng/ml may be included into this study.

Whereas the following patients will be excluded from participation: with any known contraindications to the approved fertility drugs, any contraindications to growth hormone, pregnancy (to be ruled out and documented before GH treatment), Hydrosalpinx, uterine malformations or abnormal uterine cavity, basal FSH more than 17 IU, abnormal karyotyping, with partner with severe male factor, and/or with uncontrolled endocrinopathies (DM, hyperthyroidism, hypothyroidism).

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05602090.

Guerbet is starting a new clinical trial of gadopiclenol pharmacokinetics, safety and efficacy in children < 2 Years of Age.

This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm infants after the neonatal period), using a population PK approach. Primary objective is to evaluate the PK profile of gadopiclenol in plasma following single intravenous injection of 0.05 mmol/kg body weight (BW) in pediatric population aged up to 23 months (inclusive) scheduled for a contrast-enhanced MRI examination of any body region including central nervous system (CNS).

Inclusion will be performed using an age-down staggered approach. Three age groups will be defined: patients aged 3 to 23 months (inclusive); patients aged 28 days to less than 3 months; patients aged from birth to 27 days (term newborns). The inclusions will start with the oldest patients (Group 1) and end with the youngest patients (Group 3). A total of 3 blood samples per patient will be taken post-injection for PK analysis.

The clinical trial started in September 21, 2022 and will continue throughout July 31, 2023.

Simulated concentrations at 20 minutes post injection will be primary outcome measure. Determined from population PK.

The exclusion criteria, as well as contacts and locations can be found here: https://ichgcp.net/clinical-trials-registry/NCT05590884.

The University of California, Irvine is commencing recruitment for the clinical trial of the Treatment of Meniere's Disease With Migraine Medications.

The trial officially began on the August 1, 2022 and is planned to complete by August 2024.

Meniere's disease (MD) is a chronic disease with a variety of fluctuating signs and symptoms, which include vertigo, hearing loss, tinnitus (ringing noise in the ear), aural pressure (feeling of ear fullness), and disequilibrium (lack of stability). 

The following patients may be included into this study: those with active or frequent Meniere's Disease; Male or female between the ages of 25 to 85 years; participants must be able to read and write in the English language to provide consenting.

Whereas patients with history of surgery for Meniere's Disease are exluded. There is a number of other exclusion criteria that may be consulted here: profile: https://ichgcp.net/clinical-trials-registry/NCT05582837.

The company NextCure, Inc is enrolling patients into the clinical trial investigating A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors.

This is an open-label, non-randomized, Phase 1b/2 study that will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

The trial is designed to enroll male and female 18 Years and older and is being conducted in the Hackensack Meridian Health University Medical Center- John Theurer Cancer Center, Hackensack, New Jersey, United States; University of Cincinnati Cancer Center, Cincinnati, Ohio, United States; MD Anderson Cancer Center, Houston, Texas, United States.

The study start date is October 6, 2022.

The patients that can be enrolled into this study include participants from 18 years of age on day of signing informed consent, with histologically or cytologically confirmed diagnosis of advanced unresectable and/or metastatic solid tumors, such as solid tumors that are known to be associated as MSS/MSI-low in the majority including: CRC, Gastric including GE junction, Esophageal, Ovarian, and H&amp;N cancer (regardless of prior treatment with ICIs), who have had disease progression after at least one line of systemic standard of care therapy prior to enrollment.

Participants who discontinue standard treatment due to intolerance or refuse standard treatment will also be eligible to enroll.

For the phase 2 may be enrolled participants who have ICI Refractory Solid Tumors (Cohort 1), including CRC, Gastric including GE junction, Esophageal, Endometrial, and H&amp;N cancer.Participants must have progressed on treatment with an anti-PD1/L1 monoclonal antibody (mAb) administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies. PD-1 treatment progression is defined by meeting all of the following criteria: - Has received at least 2 doses of an approved anti-PD-1/L1 mAb. - Has demonstrated disease progression after PD-1/L1 as defined by RECIST v1.1.

This page provides a more detailed overview of the inclusion and exclusion criteria, as well contact details of investigators of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05572684.

The research company AstraZeneca is conducting a 12-week (with an extension to 52 weeks in a subset of participants) study comparing the safety of BGF MDI HFO twice daily (BID) with BGF MDI HFA BID in participants with moderate to very severe COPD.

It is planned to include 542 participants. Actual study start date is September 27, 2022. The researchers expect to complete the study by June 21, 2024.

Among patients who can be enrolled are participants from 40 to 80 years of age inclusive, who have a documented history of physician-diagnosed COPD as defined by the ATS/ERS (Celli et al 2004) or by locally applicable guidelines;  who have been regularly using dual ICS/LABA, LAMA/LABA, or ICS/LAMA/LABA (open or fixed-dose combinations) inhaled maintenance therapies for the management of their COPD for at least 6 weeks prior to Screening.

The study will be conducted in several investigational sites in the following countries: the USA, Argentina, Bulgaria, Canada, Germany, Mexico, Poland, Turkey, the United Kingdom.

For more complete list of the inclusion and exclusion criteria, and for the sites contact details, please visit: https://ichgcp.net/clinical-trials-registry/NCT05573464.

Rigicon, Inc is recruiting patients for the clinical trial of Rigicon Infla10® Three-Piece Inflatable Penile Prosthesis (ERASE ED).

This study evaluates the long-term safety and efficacy of the use of the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis in patients with erectile dysfunction. This study follows patients implanted with the Rigicon Infla 10® Three-Piece Inflatable Penile Prosthesis for up to 3 years after implantation. This study will take approximately 6 months to enroll all subjects. (14 days, 1 month, 6 months, 12 months,18 months, 24 months, and 36 months, post-procedure. ) Subjects will be followed per protocol and institutional standard of care for ED and comorbidities.

A patient-activated inflatable penile prosthesis (IPP) provides patients a means to achieve dependable spontaneity for intercourse. Rigicon has developed a three-piece inflatable penile prosthesis (IPP) (Infla10®) for the treatment of ED. This proposed study is to assess the safety and effectiveness of the Rigicon IPP in treating ED. Clinical literature and preclinical testing, including biocompatibility, device validation and verification, and animal studies support the safety and efficacy of this device for the intended therapy.

Among primary outcome measures are the Survival at 12 months and Freedom from surgical revision at 12 months post-procedure.

The study will take place at the Dr. Paul Perito / Perito Urology, Coral Gables, Florida, United States; University of Health Sciences,Turkey Haydarpasa Numune Research and Training Hospital, Istanbul, Tıbbiye Cad. No: 23, Turkey.

Included will be male ≥21 years of age diagnosed with erectile dysfunction (impotence) that will agree to receive Infla10® three-piece IPP as an ED treatment and are willing to complete all protocol required follow-up visits and tests, without contraindication to general anesthesia.

The following page providea a detailed overview of the inclusion and exclusion criteria, and the contact details of study centers: https://ichgcp.net/clinical-trials-registry/NCT05574868.

The company ModernaTX, Inc is enrolling patients into the clinical trial investigating A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age.

The main purpose of study is to evaluate the safety and immunogenicity of different dose levels of mRNA-1647 versus control in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive female and male participants 9 to 15 years of age. In addition,mRNA-1647 will be evaluated in female participants 16 to 25 years as a comparator cohort.

The study start date is October 10, 2022.

The patients that can be enrolled into this study include a female or male 9 to 15 years of age or is a female 16 to 25 years of age at the time of consent, who are in good general health and is capable of complying with study procedures. Whereas, for the CMV-seronegative cohorts: at the Screening visit, a participant is CMV IgG-negative and CMV immunoglobulin M (IgM)-negative, and for CMV-seropositive cohorts, a participant is CMV IgG-positive and CMV IgM-negative, CMV IgG-positive and CMV IgM-positive, or CMV IgG-positive and CMV IgM-indeterminate. 

This page provides a more detailed overview of this clinical trial, icluding the exclusion and inclusion criteria in detail, and the investigational sites locations and contact details: https://ichgcp.net/clinical-trials-registry/NCT05575492.

Yuhan Corporation is conducting the clinical trial of YH35324 in Atopic Healthy Subjects or Subjects With Mild Allergic Diseases.

This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with mild allergic diseases, who have atopy. It is planned to include 34 participants.

It is planned to start enrollment on October 21, 2022. The researchers expect to complete the study by December 31, 2023.

One primary outcome measure is Occurrence and severity of adverse events (AEs), To evaluate the safety and tolerability following multiple administrations of YH35324.

Participants must be male or female adults aged ≥ 19 to ≤ 55 years with serum total IgE level ≥ 30 IU/mL and without any pathological symptoms or findings from medical examination, or subjects with a history of mild allergic diseases (allergic rhinitis, atopic dermatitis, food allergy, urticaria, or allergic asthma).

Whereas subjects with history of malignancy, those with positive drug screen result, having aspartate transaminase (AST) or alanine transaminase (ALT) level > 2 X the upper limit of normal, or with estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, or with allergy immunotherapy initiated or changed within 6 months prior to randomization, or with history of participation in another clinical trial within 6 months prior to randomization - will not be included into this study.

The location of the study and further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05564221.

The company Ionis Pharmaceuticals, Inc is enrolling patients into the clinical trial investigating A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia. The study start date is August 31, 2022.

The purpose of this study is to evaluate the efficacy of olezarsen as compared to placebo on the percent change in fasting triglycerides (TG) from baseline.

The trial is designed to enroll male and female 18 Years and older and is being conducted in the Louisville Metabolic and Atherosclerosis Research Center (L-MARC), Louisville, Kentucky; Pioneer Research Solutions, Inc, Houston, Texas; FMC Science, Lampasas, Texas; Texas Institute of Cardiology, McKinney, Texas, United States.

Patients that may be enrolled must have Fasting TG ≥ 500 mg/dL (5.65 mmol/L) at Screening and Qualification visits, be on lipid-lowering therapy that should adhere to standard of care (SOC) per local guidelines, and they must be willing to comply with diet and lifestyle recommendations as able.

Among the exclusion Criteria are Hemoglobin A1c (HbA1c) ≥ 9.5% at Screening;  Alanine aminotransferase or aspartate aminotransferase > 3.0 × upper limit of normal; Total bilirubin > 1.5 ULN unless due to Gilbert's syndrome; Estimated GFR < 30 mL/min/1.73 m^2

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05552326.

The company Small Pharma Ltd is commencing recruitment for the clinical trial of the SPL026 With or Without SSRIs in Participants With MDD.

The trial will start in October 2022 and is planned to complete by February 2023.

The main aim of the study is to test the safety and tolerability of single doses of SPL026 (N,N-dimethyltryptamine [DMT] fumarate, a psychedelic tryptamine) in patients currently taking a selective serotonin reuptake inhibitor (SSRI) for their depression, but for whom the SSRI is not fully relieving their depression.

Patients with MDD diagnosis  who previously tried at least one approved method of treatment for their depression and have not  received any monoamine oxidase-inhibitor class antidepressants for at least 3 months. The eligible participants shall be deemed healthy on the basis of a clinical history, physical examination, ECG, vital signs, laboratory tests of blood and urine, without psychedelic drug use in the 6 months before dosing until the end of the study. 

The link to the complete study profile, including the exclusion criteria and the study location can be found here: https://ichgcp.net/clinical-trials-registry/NCT05553691.

This study aims to obtain data on the potential influence of Vine to Bar product(s) containing Chardonnay marc on cardiometabolic health. These initial studies will inform the design and timing of data collection for future dietary intervention trials that will examine the influence of Chardonnay marc intake on outcomes/biomarkers of both cardiometabolic health and the gut microbiome. This includes collecting data on the potential differences in response to the products based on the unique food matrix for each of the products that will be tested. Moreover, as there is a paucity of data on the influence of cocoa flavanol intake on vascular function beyond 4 hours post intake, the response of the selected outcomes will be assessed after 6 hours of flavanol intake. This is a time point that captures the increased circulating presence of microbial derived flavanol metabolites.

The trial is designed to enroll Male 30 Years to 50 Years and is being conducted in the Academic Surge, University of California, Davis, California, United States.

The patients that can be enrolled into this study include those having at screening or Visit 1 Reactive Hyperemia Index (RHI; EndoPAT 2000)  < 2.0; willing and able to comply with the study protocols; willing to participate in all study procedures, and having BMI 25.0 - 35 kg/m2.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05545865.

The company Pardes Biosciences, Inc is commencing recruitment for the clinical trial of the PBI-0451 Phase 2 Study in Nonhospitalized Symptomatic Adults With COVID-19. The study will take place at several investigational sites in Florida, the USA.

PBI-0451 is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. This study is designed to evaluate the antiviral activity, safety, and efficacy of orally administered PBI-0451 compared with placebo.

Among the primary inclusion criteria are:

1. Can understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of any study procedures.
2. Onset of COVID-19 symptoms ≤ 5 days prior to randomization with a positive SARS-CoV-2 test ≤ 24 hours prior to randomization. Authorized NAAT or antigen tests that detect viral RNA or protein, respectively, are allowed.
3. Received primary vaccination series as defined by Centers for Disease Control and Prevention (CDC). Subjects should be advised during informed consent that alternate therapies may be available outside of study participation.

The link to the complete list of the inclusion/excluison criteria, and the sites contact details: https://ichgcp.net/clinical-trials-registry/NCT05543707.

Northumbria University, Newcastle upon Tyne, United Kingdom, is conducting the clinical trial Immediate and Residual Effects of Functional Chewing Gum on Concentration.

Previous research suggests that chewing gum may influence several functions including attention and alertness. Gum can also be used as a vehicle for delivering ingredients that have the ability to modulate attention and mood.

This study will explore the effects of a functional gum containing a proprietary composition of a herbal extract and vitamins. These effects will be compared to the effects of a basic sugar-free gum and to a tablet which will include the same ingredients as the basic sugar-free gum. Effects will be explored on computerised measures of attention/concentration and via ratings of current mood. The study will assess the immediate effects of chewing gum as well as the effects 1 hour later. There will be an initial remote screening session followed by visits to the laboratory on 4 separate occasions: an introductory/training visit and three active study days.

It is planned to include 40 participants. The researchers expect to complete the study by January 4, 2023.

One primary outcome measure is Simple Reaction Time, Cognitive Function - attention.

Participants must self-assess themselves as being in good health and be 18 to 35 years at the time of giving consent, with chewing ability and proficient in English.  They cannot participate if have any pre-existing medical condition/illness which will impact taking part in the study.

Further details can be found here: https://ichgcp.net/clinical-trials-registry/NCT05544500.

The Department of Neurology, Semmelweis University, Budapest, Hungary is enrolling patients into the clinical trial investigating the prognostic value of biomarkers and the effect of tolperisone in acute low back pain and sciatic pain "BETA".

The main purpose of the trial is to identify biomarkers from the blood as well as electrophysiologic and morphometric features (chemical, electrophysiologic and ultrasound biomarkers) that reflect the intensity of pain and/or foretell the efficacy of pharmacological (non-surgical) treatment in patients with acute low back pain. The trial is designed to enroll male and female 18 to 80 years who are healthy pain-free volunteers (n=30) without pain or inflammation outside of the randomized study, to establish normal values of blood biomarkers. 

Patients with acute (less than 1-month) low back pain with or without radicular signs, who do not have severe diseases (abscess, tumor, etc) in the background, already had CT or MRI scan during routine workup will also be included.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT05544656.

Pusan National University Yangsan Hospital is conducting the clinical trial Ice Plant (Mesembryanthemum Crystallinum) Extract in Patients With Impaired Fasting Glucose.

The investigators will conduct a randomized, double-blind, placebo-controlled study to investigate the effects and tolerability of ice plant (Mesembryanthemum crystallinum) extract in patients with impaired fasting glucose for 12 weeks. It is planned to include 40 participants. The researchers expect to complete the study by December 31, 2022.

Patients with with fasting blood glucose of 100 mg/dL or more and less than 140 mg/dL may participate. There is a number of exclusion criteria, such as suffering from type 1 or type 2 diabetes, previous history of drugs that may affect blood glucose within 3 months, taking health functional food that can affect blood glucose within 1 month or health functional food can affect the interpretation of the results of this study, taking systemic steroids within 1 month, having lost in weight within the last 3 months, suffering form severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.) within the last 6 months), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia that needs to be treated), or a malignant tumor, local or systemic inflammatory diseases, renal disease such as hereditary hyperlipidemia, acute/chronic renal failure, nephrotic syndrome. The complete list of the exlcusion criteria, as well as the location of the study can be found here: https://ichgcp.net/clinical-trials-registry/NCT05544825.