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.
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
60
150 mgSubcutaneous injection
Qianfoshan Hospital
Ji'nan, China
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%.
Time frame: Baseline and Week 12
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%.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: From first dose through Week 12
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