Tafolecimab in Hyperlipidemia: A Study of Different Dosing Intervals

NCT07712042 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2026(001)
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperlipidemia

Keywords

Tafolecimab; PCSK9 inhibitor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percent Change in Lipoprotein(a) from Baseline at Week 12

  Baseline and Week 12

• LDL-C Target Achievement Rate

  At Week 2, 6, 12 (Q2W group) and Week 3, 9, 12 (Q3W group)

• Changes in Other Lipid Parameters

  Baseline and each designated visit (through Week 12)

• Safety and Tolerability Profile

  From first dose through Week 12

Study Arms (2)

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

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

Interventions

Tafolecimab DRUG

150 mgSubcutaneous injection

Also known as: 托莱西单抗

Tafolecimab 150 mg Q2W; Tafolecimab 150 mg Q3W

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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;
• 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;
• Severe heart failure: left ventricular ejection fraction ≤ 30%;
• Secondary dyslipidemia caused by factors such as thyroid dysfunction, nephrotic syndrome, or familial hyperlipidemia;
• Patients with connective tissue diseases, rheumatic or autoimmune diseases, rhabdomyolysis, hematologic disorders, or malignancies, combined with other types of intracranial diseases;
• Patients who have experienced an allergic reaction while taking oral statins or receiving Tafolecimab injections, as well as those with clear contraindications;
• Patients with a history of major surgery or trauma, or who have developed severe acute or chronic infections during the follow-up period;
• Pregnant women;
• Patients with serious illnesses and a life expectancy of ≤3 months, such as those with malignant tumors;
• 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.
• Participants meeting any of the above criteria must be excluded.

Sponsors & Collaborators

• Mei Gao: lead

Study Sites (1)

Qianfoshan Hospital

Ji'nan, China

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Mei Gao

CONTACT

0531-89269317; lixinyan0514@163.com

Yanxin Li

CONTACT

0531-89269317; lixinyan0514@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, Department of Cardiology

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 17, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)