Tafolecimab in Hyperlipidemia: A Study of Different Dosing Intervals

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMei Gao

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Tafolecimab

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Qianfoshan Hospital Status unavailable Ji'nanChinaChina

Sponsors and collaborators

Mei Gao

Lead sponsor

Qianfoshan Hospital

Sponsor institution