- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04019197
Effects of Semaglutide in HIV-Associated Lipohypertrophy
March 20, 2024 updated by: Allison Eckard, Case Western Reserve University
Effects of GLP-l Receptor Agonists on Cardiometabolic Alterations in HIV-associated Lipohypertrophy
This is a randomized, double-blinded, placebo-controlled trial designed to assess the effect of the GLP-1 receptor agonist, semaglutide, on visceral and ectopic fat, insulin resistance, inflammation markers, and the downstream effect of cardiovascular risk in people with HIV.
The primary endpoints will be visceral and ectopic fat changes over the study period.
The secondary endpoints will include changes in markers of inflammation, immune activation, gut integrity, and cardiovascular disease risk assessment.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This study is a phase IIb, randomized, double-blinded, placebo-controlled clinical trial of semaglutide in people with HIV-associated lipohypertrophy.
Participants will be recruited from 1 site (Cleveland, OH).
The duration of the study will be 56 weeks.
The interventional phase will last 32 weeks, followed by a 24-week observational phase to assess the sustainability of the intervention.
Participants will be randomized 1:1 to receive semaglutide by subcutaneous injection once weekly for 32 weeks (8-week dose escalation phase followed by full-dose for 24 weeks) or matching placebo.
The primary objective of this clinical trial is to determine the efficacy of semaglutide in treating lipohypertrophy among non-diabetic people living with HIV by reducing fat accumulation and ectopic fat deposition, altering adipokine levels, improving endothelial function and arterial stiffness, down-regulating key pro-inflammatory cytokines and immune activation without modifying microbial translocation and gut integrity markers.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Grace A McComsey, MD
- Phone Number: 216-844-5936
- Email: grace.mccomsey@uhhospitals.org
Study Contact Backup
- Name: Allison R Eckard, MD
- Phone Number: 843-876-4541
- Email: eckarda@musc.edu
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- Case Western Reserve University
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Male or female, aged ≥18 years.
- HIV-1 infection as documented by any licensed ELISA test kit and confirmed by Western blot at any time prior to study entry. HIV-1 culture, HIV-1 antigen, plasma HIV-1 RNA, or a second antibody test by a method other than ELISA is acceptable as an alternative confirmatory test.
- Body mass index ≥25 kg/m2.
- Waist circumference and waist-to-hip ratio >95 cm and >0.94 cm, respectively, for men, and >94 cm and >0.88 cm, respectively, for women occurring in the context of HIV treatment.
- Subjective evidence of increased abdominal girth occurring after initiation of HIV treatment.
- HIV-1 RNA <400 copies/mL for ≥6 months.
- Receiving a stable antiretroviral regimen for at least the last 12 weeks prior to study entry with cumulative duration of 1 year of treatment at the time of study entry.
- Provision of signed and dated informed consent form and is capable of reading and comprehending the informed consent.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- All women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to start of study medication. WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who is not postmenopausal (defined as amenorrhea 12 consecutive months), or is on hormone replacement therapy (HRT) with documented plasma follicle-stimulating hormone level 35 mIU/mL. Women who are using oral, implanted, or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered of child-bearing potential.
- Female subjects who are not of reproductive potential (have reached menopause or undergone hysterectomy, bilateral oophorectomy or tubal ligation) or whose male partner has undergone successful vasectomy with resulting azoospermia or has azoospermia for any other reason, are eligible without requiring the use of contraception. Patient-reported history of menopause, sterilization, and azoospermia is considered acceptable documentation.
- All subjects must not participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the female subject/male partner must use condoms (male or female) in addition to one of the following forms of contraception while on study: either a spermicidal agent, diaphragm, cervical cap, IUD, or hormonal-based contraception.
- Have no plans to alter antiretroviral therapy, or to undergo any weight loss program, formal exercise training or surgery during the study period, or initiate structured/strategic antiretroviral treatment interruptions.
Exclusion Criteria:
- Known cardiovascular disease or diagnosed diabetes. If on metformin without a diabetes diagnoses metformin use has to be constant, uninterrupted for 6 months prior to entry.
- Any active or chronic uncontrolled inflammatory condition, infection or cancer.
- Women who are pregnant or breastfeeding.
- Women with a positive pregnancy test on enrollment or prior to study drug administration.
- A clinically-relevant illness within 14 days prior to study entry not explicitly excluded by the protocol, a physical or psychiatric disability, or a laboratory abnormality that might place the subject at increased risk by being exposed to the medications in this study or which might confound the interpretation of this investigation.
- Active gastrointestinal symptom Grade >1 within the last month.
- Regular use of immunomodulators/agents which could impact inflammation. Regular use of NSAIDS allowed if constant, uninterrupted for 6 months and no plans to alter. Statin use must also be constant, uninterrupted for 6 months prior to study entry. Thyroid medication allowed unless diagnosed with uncontrolled thyroid disease.
- Inability to communicate effectively with study personnel.
- Use of megestrol acetate, testosterone, or any steroid use beyond normal amounts found in the body within 6 months of study, or intend to start.
- Glomerular filtration rate <50 cc/min/1.73 m2.
- Hemoglobin <10 g/dL.
- Elevated lipase level >1.5 upper limit of normal
- AST AND ALT >2.5x upper limit of normal.
- Use of growth hormone or growth hormone-releasing hormone in the last year, or intent to start.
- History of excessive alcohol use (on average 2 or more drinks a day) , pancreatitis, thyroid cancer, or a diagnosis of multiple endocrine neoplasia (MEN) syndrome type 2.
- History of lactose intolerance or inability to consume milk products will be exclusionary for participation in the mixed-meal tolerance test portion of the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Participants with HIV and lipohypertrophy: semaglutide arm
Participants with HIV/lipohypertrophy will receive semaglutide 0.25 mg x4 weeks, then semaglutide 0.5 mg x4 weeks, then semaglutide 1.0 mg x24 weeks, then no drug x24 weeks.
|
semaglutide subcutaneous injection
Other Names:
|
Placebo Comparator: Participants with HIV and lipohypertrophy: placebo arm
Participants with HIV/Lipohypertrophy will receive placebo x32 weeks, then no placebo for 24 weeks.
|
placebo injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of semaglutide on quantity of abdominal fat (total, subcutaneous, visceral)
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of abdominal fat (total, subcutaneous, visceral) as measured in area via abdominal CT scan.
|
32 weeks
|
Effects of semaglutide on quantity of fat (total body fat, limb fat, trunk fat)
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of abdominal fat (total, subcutaneous, visceral) as measured in mass via whole-body DXA scan.
|
32 weeks
|
Effects of semaglutide on quantity of pericardial fat
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of pericardial fat as measured in volume by chest CT scan.
|
32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of semaglutide on liver fat
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on liver fat as measured by density via abdominal CT scan.
|
32 weeks
|
Effects of semaglutide on quantity of lean body mass
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of lean body mass as measured by whole-body DXA scan.
|
32 weeks
|
Effects of semaglutide on quantity of total right psoas muscle
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the amount of total right psoas muscle as measured in area via CT scan.
|
32 weeks
|
Effects of semaglutide on quality of abdominal fat (total, subcutaneous, visceral)
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the quality of abdominal fat (total, subcutaneous, visceral) as measured by density via CT scan.
|
32 weeks
|
Effects of semaglutide on quality of pericardial fat
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the quality of pericardial fat (total, subcutaneous, visceral) as measured by density via abdominal CT scan.
|
32 weeks
|
Effects of semaglutide on quality of total right psoas muscle
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on the quality/intermuscular fat content of total right psoas muscle as measured by density via CT scan.
|
32 weeks
|
Effects of semaglutide on anthropometric measurements (weight, waist circumference, waist-to-hip ratio)
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on anthropometric measurements.
|
32 weeks
|
Effects of semaglutide on glucose metabolism
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.
|
32 weeks
|
Effects of semaglutide on lipoprotein profiles
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on lipoprotein profiles and oxidized LDL levels.
|
32 weeks
|
Effects of semaglutide on systemic inflammation
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on soluble markers of inflammation and immune activation to assess overall level of systemic inflammation.
|
32 weeks
|
Effects of semaglutide on systemic immune activation
Time Frame: 32 weeks
|
Effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on cellular markers of inflammation and immune activation markers to assess overall level of systemic immune activation.
|
32 weeks
|
Effects of semaglutide on insulin sensitivity/resistance
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on insulin sensitivity/insulin resistance by assessing insulin levels, HOMA-IR (calculated based on insulin levels and glucose levels), and timed insulin levels as part of a 4-hour mixed meal tolerance test.
|
32 weeks
|
Effects of semaglutide on gut hormones
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, in the gut hormones, GIP and GLP-1 levels, by means of a 4-hour mixed-meal tolerance test.
|
32 weeks
|
Effects of semaglutide on gut integrity
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, in select measures of gut integrity and microbial translocation (e.g., I-FABP, zonulin-1, LPS).
|
32 weeks
|
Effects of semaglutide on resting energy expenditure
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, in resting energy expenditure by means of indirect calorimetry.
|
32 weeks
|
Effects of semaglutide on pulse wave velocity
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, in pulse wave velocity, a measure of arterial stiffness, as a surrogate measure of cardiovascular disease risk.
|
32 weeks
|
Effects of semaglutide on EndoPat
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, in EndoPat, a measure of endothelial function, as a surrogate measure of cardiovascular disease risk.
|
32 weeks
|
Effects of semaglutide on coronary artery calcium (CAC) score
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, in coronary artery calcium (CAC) score as measured by chest CT scan.
|
32 weeks
|
Effects of semaglutide on overall cardiovascular disease (CVD) risk
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, in overall cardiovascular disease (CVD) risk.
|
32 weeks
|
Effects of semaglutide on bone
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on bone markers and total bone mineral content as measured by whole-body DXA scan.
|
32 weeks
|
Effects of semaglutide on dietary intake
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on dietary intake via comprehensive dietary intake assessments.
|
32 weeks
|
Effects of semaglutide on physical activity
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on physical activity status via comprehensive physical activity assessments.
|
32 weeks
|
Safety analyses
Time Frame: 32 weeks
|
Safety of semaglutide in HIV will be investigated, including a comparison between participants receiving semaglutide vs. placebo, on adverse events, side effects, and related safety endpoints.
|
32 weeks
|
Sustainability of effects of semaglutide on quantity of abdominal fat (total, subcutaneous, visceral)
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of abdominal fat (total, subcutaneous, visceral) as measured in area via abdominal CT scan.
|
56 weeks
|
Sustainability of effects of semaglutide on quantity of fat (total body fat, limb fat, trunk fat)
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of total fat, limb fat, and trunk fat as measured in mass via whole-body DXA scan.
|
56 weeks
|
Sustainability of effects of semaglutide on quantity of pericardial fat
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of pericardial fat as measured in volume by chest CT scan.
|
56 weeks
|
Sustainability of effects of semaglutide on liver fat
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on liver fat as measured by density via abdominal CT scan.
|
56 weeks
|
Sustainability of effects of semaglutide on quantity of lean body mass
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of lean body mass as measured by whole-body DXA scan.
|
56 weeks
|
Sustainability of effects of semaglutide on quantity of total right psoas muscle
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the amount of total right psoas muscle as measured in area via CT scan.
|
56 weeks
|
Sustainability of effects of semaglutide on quality of abdominal fat (total, subcutaneous, visceral)
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality of abdominal fat (total, subcutaneous, visceral) as measured by density via CT scan.
|
56 weeks
|
Sustainability of effects of semaglutide on quality of pericardial fat
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality of pericardial fat as measured by density via chest CT scan.
|
56 weeks
|
Sustainability of effects of semaglutide on quality of total right psoas muscle
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on the quality/intermuscular fat content of total right psoas muscle as measured in density via CT scan.
|
56 weeks
|
Sustainability of effects of semaglutide on anthropometric measurements (weight, waist circumference, waist-to-hip ratio)
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on anthropometric measurements.
|
56 weeks
|
Sustainability of effects of semaglutide on glucose metabolism
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on glucose metabolism by assessing oral glucose tolerance, fasting glucose levels, and HgbA1C.
|
56 weeks
|
Sustainability of effects of semaglutide on lipoprotein profiles
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on lipoprotein profiles and oxidized LDL levels.
|
56 weeks
|
Sustainability of effects of semaglutide on systemic inflammation
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on soluble markers of inflammation and immune activation markers to assess overall level of systemic inflammation.
|
56 weeks
|
Sustainability of effects of semaglutide on systemic immune activation
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on cellular markers of inflammation and immune activation markers to assess overall level of systemic immune activation.
|
56 weeks
|
Sustainability of effects of semaglutide on insulin sensitivity/resistance
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on soluble markers of inflammation and immune activation markers by assessing insulin levels, HOMA-IR (calculated based on insulin levels and glucose levels), and timed insulin levels as part of a 4-hour mixed meal tolerance test.
|
56 weeks
|
Sustainability of effects of semaglutide on gut hormones
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on gut hormones, GIP and GLP-1 levels, by means of a 4-hour mixed-meal tolerance test.
|
56 weeks
|
Sustainability of effects of semaglutide on gut integrity
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on gut integrity and microbial translocation (e.g., I-FABP, zonulin-1, LPS).
|
56 weeks
|
Sustainability of effects of semaglutide on resting energy expenditure
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on resting energy expenditure by means of indirect calorimetry.
|
56 weeks
|
Sustainability of effects of semaglutide on pulse wave velocity
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on pulse wave velocity, a measure of arterial stiffness, as a surrogate measure of cardiovascular disease risk.
|
56 weeks
|
Sustainability of effects of semaglutide on EndoPat
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on EndoPat, a measure of endothelial function, as a surrogate measure of cardiovascular disease risk.
|
56 weeks
|
Sustainability of effects of semaglutide on coronary artery calcium (CAC) score
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on coronary artery calcium (CAC) score as measured by chest CT scan.
|
56 weeks
|
Sustainability of effects of semaglutide on overall cardiovascular disease (CVD) risk
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on overall cardiovascular disease (CVD) risk.
|
56 weeks
|
Sustainability of effects of semaglutide on bone
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on bone markers and total bone mineral content as measured by whole-body DXA scan.
|
56 weeks
|
Sustainability of effects of semaglutide on dietary intake
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on dietary intake via comprehensive dietary intake assessments.
|
56 weeks
|
Sustainability of effects of semaglutide on physical activity
Time Frame: 56 weeks
|
Sustainability of effects of semaglutide after treatment discontinuation will be investigated, including a comparison of changes over time between participants who received semaglutide vs. placebo, on physical activity status via comprehensive physical activity assessments.
|
56 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes over time in HIV-associated lipohypertrophy
Time Frame: 56 weeks
|
All outcome measures will be assessed for changes over time among participants receiving placebo to help determine the natural course of lipohypertrophy in HIV.
|
56 weeks
|
Effects of semaglutide on adipokines and natriuretic peptides
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on adipokines and natriuretic peptides to help elucidate the potential mechanism by which GLP-1 may affect metabolic endpoints.
|
32 weeks
|
Exploratory investigation of mechanisms of semaglutide effects on outcome measures
Time Frame: 32 weeks
|
Outcome measures will be evaluated for possible mechanisms/pathways that help elucidate causal effects of semaglutide in people with HIV/HIV-associated lipohypertrophy.
|
32 weeks
|
Effects of semaglutide on neurocognitive scores
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on neurocognitive scores assessed using Cognivue test.
|
32 weeks
|
Effects of semaglutide on skin AGE measurements
Time Frame: 32 weeks
|
Effects of semaglutide will be investigated, including a comparison of changes over time between participants receiving semaglutide vs. placebo, on skin AGE measurements via AGE Reader instrument.
|
32 weeks
|
Sustainability of effects of semaglutide on natriuretic peptides
Time Frame: 56 weeks
|
A comparison of changes over time will be made between participants receiving semaglutide vs. placebo in adipokines and natriuretic peptides to help elucidate the potential mechanism by which GLP-1 may affect metabolic endpoints.
|
56 weeks
|
Sustainability of effects of semaglutide on neurocognitive scores
Time Frame: 56 weeks
|
A comparison of changes over time will be made between participants receiving semaglutide vs. placebo in neurocognitive scores assessed using Cognivue test.
|
56 weeks
|
Sustainability of effects of semaglutide on skin AGE measurements
Time Frame: 56 weeks
|
A comparison of changes over time will be made between participants receiving semaglutide vs. placebo in skin AGE measurements via AGE Reader instrument.
|
56 weeks
|
Investigation of mechanisms of semaglutide effects and sustainability of effects on outcome measures
Time Frame: 56 weeks
|
Outcome measures will be evaluated for possible mechanisms/pathways that help elucidate causal effects of semaglutide in people with HIV.
|
56 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Grace A McComsey, MD, Case Western Reserve University
- Principal Investigator: Allison R Eckard, MD, Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 16, 2019
Primary Completion (Actual)
September 30, 2023
Study Completion (Estimated)
March 31, 2025
Study Registration Dates
First Submitted
July 1, 2019
First Submitted That Met QC Criteria
July 11, 2019
First Posted (Actual)
July 15, 2019
Study Record Updates
Last Update Posted (Actual)
March 21, 2024
Last Update Submitted That Met QC Criteria
March 20, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY20190121
- R01DK121619 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Sharing of data generated by this project is an essential part of our proposed activities and will be carried out to comply with the NIH policy on Sharing Research Data.
We wish to make our results available both to the community of scientists interested in HIV infection, immune activation and co-morbidities, as well as to people living with HIV infection.
The data generated in this project will be presented at local, national and international conferences and published in peer-reviewed journals in a timely fashion.
All final peer-reviewed manuscripts that arise from this project will be submitted to PubMed Central.
The PI will work to facilitate any request made for data produced under this proposal upon publication of data, using standard, university-approved material/data transfer agreements.
IPD Sharing Time Frame
after publication
IPD Sharing Access Criteria
individual requests will be reviewed by study PIs.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
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Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
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Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
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Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
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Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
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Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
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Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
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Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
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University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Semaglutide Injectable Product
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Amir MoheetCystic Fibrosis FoundationRecruiting
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Qilu Pharmaceutical Co., Ltd.Not yet recruiting
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University College DublinUniversity of Copenhagen; Rush University Medical CenterRecruitingObesity | HIV-1-infectionIreland
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University of HullNot yet recruitingPolycystic Ovary SyndromeUnited Kingdom
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Axel BrandesHillerod Hospital, Denmark; Herlev and Gentofte Hospital; Svendborg Hospital; Hospital...WithdrawnAtrial Fibrillation | Overweight and Obesity
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The University of Texas Health Science Center at...National Institute on Aging (NIA)Active, not recruitingDiabetes Mellitus, Type 2 | PreDiabetes | Aging | Overweight and ObesityUnited States
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University of California, Los AngelesRecruitingObesityUnited States
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Psoriasis Treatment Center of Central New JerseySun Pharmaceutical Industries LimitedUnknown
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Tang-Du HospitalRecruitingMyasthenia Gravis, GeneralizedChina
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University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingObese | PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesUnited States