Tafolecimab in Hyperlipidemia: A Study of Different Dosing Intervals

July 15, 2026 updated by: Mei Gao

Efficacy and Safety of Tafolecimab With Different Dosing Intervals in Patients With Hyperlipidemia

This is a prospective, observational cohort study. Patients will be assigned to either the Q2W or Q3W group based on the treating physician's clinical decision, not by randomization. The aim is to evaluate the real-world effectiveness and safety of the two dosing regimens.This study aims to systematically evaluate the lipid-lowering efficacy and safety of two dosing regimens of Tafolecimab 150 mg-administered every two weeks (Q2W) versus every three weeks (Q3W)-over a 12-week period in patients with hyperlipidemia whose LDL-C remains above the target after 4 weeks of treatment with moderate-intensity statins with or without cholesterol absorption inhibitors. The primary efficacy endpoint is the percent change in LDL-C from baseline at week 12 of the initial treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a prospective, observational cohort study conducted at the Department of Cardiology, Shandong First Medical University Affiliated First Hospital (Qianfoshan Hospital). The study aims to compare the efficacy and safety of Tafolecimab 150 mg administered every two weeks (Q2W) versus every three weeks (Q3W) in patients with hyperlipidemia who have not achieved their LDL-C targets after at least 4 weeks of moderate-intensity statin therapy, with or without cholesterol absorption inhibitors.

A total of 60 patients will be enrolled, with 30 patients allocated to each group based on clinical decision-making. Group A will receive Tafolecimab 150 mg subcutaneously every 2 weeks (Q2W), and Group B will receive Tafolecimab 150 mg subcutaneously every 3 weeks (Q3W). The treatment period is 12 weeks for both groups.

The primary efficacy outcome is the percent change in LDL-C from baseline at week 12. Secondary efficacy outcomes include the percent change in Lp(a) from baseline at week 12, LDL-C target achievement rates at each follow-up visit, and changes in TC, TG, HDL-C,, ApoB, and ApoA1 levels. Safety outcomes include the incidence of injection site reactions, liver transaminase elevation (ALT/AST ≥ 3×ULN), creatine kinase elevation (CK ≥ 5×ULN).

Follow-up visits are scheduled at week 2, 6, and 12 for Group A, and at week 3, 9, and 12 for Group B.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with hyperlipidemia who have received moderate-intensity statin therapy for at least 4 weeks prior to enrollment, with or without cholesterol absorption inhibitors, and who have not achieved LDL-C targets according to the 2023 Chinese Lipid Management Guidelines based on their ASCVD risk stratification , or patients for whom clinicians anticipate that LDL-C targets will not be achieved with continued moderate-intensity statin therapy and who are planned to receive PCSK9 inhibitor treatment.

Description

Inclusion Criteria:

  • 1) Age ≥18 years. 2) Diagnosed with hyperlipidemia and on a stable, regular dose of moderate-intensity statins for at least 4 weeks (specifically: Atorvastatin 10 mg/d, Rosuvastatin 5 mg/d, Fluvastatin 80 mg/d, Pitavastatin 2-4 mg/d, Pravastatin 40 mg/d, Simvastatin 20-40 mg/d, or Xuezhikang 1.2 g/d), with or without concurrent cholesterol absorption inhibitors.

    3) Baseline LDL-C levels failing to reach the therapeutic target corresponding to the patient's ASCVD risk categorization (defined as follows):ASCVD Primary Prevention (Low Risk): LDL-C ≥ 3.4 mmol/L；ASCVD Primary Prevention (Moderate/High Risk): LDL-C ≥ 2.6 mmol/L；ASCVD Secondary Prevention (Very High Risk): LDL-C ≥ 1.8 mmol/L OR reduction from baseline ≥ 50%；ASCVD Secondary Prevention (Ultra-High Risk): LDL-C ≥ 1.4 mmol/L OR reduction from baseline ≥ 50% 4) Meets the standard clinical criteria for PCSK9 inhibitor initiation, OR the treating physician estimates that continuing current moderate-intensity statins cholesterol absorption inhibitor therapy will not achieve the target LDL-C levels, thereby requiring combination therapy with a PCSK9 inhibitor.

    5) First-time user of tafolecimab (PCSK9 inhibitor-naïve). 6) Voluntarily participates in the study, provides written informed consent, and meets all follow-up compliance requirements.

    7) Candidates must meet ALL of the above criteria to be eligible for enrollment in the study.

Exclusion Criteria:

  1. Marked liver function abnormalities at enrollment: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) levels 3 times or more above the upper limit of the normal reference range;
  2. Renal insufficiency at enrollment: serum creatinine levels above the upper limit of the normal reference range and/or endogenous creatinine clearance below the lower limit of the normal reference range;
  3. Severe heart failure: left ventricular ejection fraction ≤ 30%;
  4. Secondary dyslipidemia caused by factors such as thyroid dysfunction, nephrotic syndrome, or familial hyperlipidemia;
  5. Patients with connective tissue diseases, rheumatic or autoimmune diseases, rhabdomyolysis, hematologic disorders, or malignancies, combined with other types of intracranial diseases;
  6. Patients who have experienced an allergic reaction while taking oral statins or receiving Tafolecimab injections, as well as those with clear contraindications;
  7. Patients with a history of major surgery or trauma, or who have developed severe acute or chronic infections during the follow-up period;
  8. Pregnant women;
  9. Patients with serious illnesses and a life expectancy of ≤3 months, such as those with malignant tumors;
  10. Other circumstances deemed unsuitable for participation by the investigators, including any medical or non-medical conditions that may increase the subject's risk, interfere with study assessments, or affect the subject's ability to complete the study.
  11. Participants meeting any of the above criteria must be excluded.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Tafolecimab 150 mg Q2W
Participants receive Tafolecimab 150 mg subcutaneously every 2 weeks (Q2W) for 12 weeks. This group includes 30 patients with hyperlipidemia who have not achieved LDL-C targets after at least 4 weeks of moderate-intensity statin therapy with or without cholesterol absorption inhibitors.
Drug: Tafolecimab
150 mgSubcutaneous injection
Other Names:
  • 托莱西单抗
Tafolecimab 150 mg Q3W
Participants receive Tafolecimab 150 mg subcutaneously every 3 weeks (Q3W) for 12 weeks. This group includes 30 patients with hyperlipidemia who have not achieved LDL-C targets after at least 4 weeks of moderate-intensity statin therapy with or without cholesterol absorption inhibitors.
Drug: Tafolecimab
150 mgSubcutaneous injection
Other Names:
  • 托莱西单抗

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change from Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
Percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Week 12. Calculated as: (Week 12 value - Baseline value) / Baseline value × 100%.
Baseline and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change in Lipoprotein(a) from Baseline at Week 12
Time Frame: Baseline and Week 12
Percent change in lipoprotein(a) [Lp(a)] from baseline to Week 12. Calculated as: (Week 12 value - Baseline value) / Baseline value × 100%.
Baseline and Week 12
LDL-C Target Achievement Rate
Time Frame: At Week 2, 6, 12 (Q2W group) and Week 3, 9, 12 (Q3W group)
Proportion of participants achieving guideline-recommended LDL-C targets based on their ASCVD risk stratification at each designated visit (Week 2, 6, 12 for Q2W group; Week 3, 9, 12 for Q3W group).
At Week 2, 6, 12 (Q2W group) and Week 3, 9, 12 (Q3W group)
Changes in Other Lipid Parameters
Time Frame: Baseline and each designated visit (through Week 12)
Changes from baseline in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), apolipoprotein B (ApoB), and apolipoprotein A1 (ApoA1) at each designated visit.
Baseline and each designated visit (through Week 12)
Safety and Tolerability Profile
Time Frame: From first dose through Week 12
Incidence and severity of adverse events (AEs), including injection site reactions (erythema, swelling, induration, pain, pruritus), systemic reactions (flu-like symptoms, headache, fatigue), transaminase elevation ≥3× ULN, creatine kinase elevation ≥5× ULN, and cases of very low LDL-C (<0.5 mmol/L) with duration.
From first dose through Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mei Gao

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YXLL-KY-2026(001)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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