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
Locations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and collaborators
Mei Gao
Lead sponsor
Qianfoshan Hospital
Sponsor institution