Tafolecimab in Hyperlipidemia: A Study of Different Dosing Intervals

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: Not yet recruiting
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: Tafolecimab

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: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Mei Gao; Phone Number: 0531-89269317; Email: lixinyan0514@163.com
• Study Contact Backup: Name: Yanxin Li; Phone Number: 0531-89269317; Email: lixinyan0514@163.com

Study Locations

• China
  • Ji'nan, China
    • Qianfoshan Hospital
    • Contact: Mei Gao; Phone Number: 0531-89269317; Email: lixinyan0514@163.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Percent Change from Baseline in LDL-C at 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

Outcome Measure	Measure Description	Time Frame
Percent Change in Lipoprotein(a) from Baseline at 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	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	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	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

• Sponsor: Mei Gao

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: PCSK9 inhibitor; Tafolecimab
• Additional Relevant MeSH Terms: Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders; Nutritional and Metabolic Diseases; Hyperlipidemias
• Other Study ID 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