QLC7401 Monotherapy in Non-familial Hypercholesterolemia or Mixed Dyslipidemia

Evaluation of Efficacy and Safety of QLC7401 Monotherapy in Participants With Non-familial Primary Hypercholesterolemia or Mixed Dyslipidemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study

This Phase III clinical trial aims to assess the efficacy and safety of QLC7401 monotherapy in adults with non-familial primary hypercholesterolemia or mixed dyslipidemia who are not receiving lipid-lowering therapy. Participants will be randomly assigned to receive subcutaneous injections of either QLC7401 or a placebo according to the study schedule.

Inclusion Criteria:

• Aged ≥18 years.
• Fasting low density lipoprotein cholesterol (LDL-C) ≥2.6 mmol/L and <4.9 mmol/L at screening.
• Atherosclerotic cardiovascular disease (ASCVD) risk stratification as low or intermediate risk per Chinese guidelines.
• Not currently on lipid-lowering therapy.
• estimated Glomerular Filtration Rate (eGFR) >30 mL/min/1.73 m².
• Willing to provide informed consent.

Exclusion Criteria:

• History of AAtherosclerotic cardiovascular disease (ASCVD)(e.g., myocardial infarction, stroke).
• Familial hypercholesterolemia.
• Uncontrolled hypertension (Systolic Blood Pressure ≥160 mmHg or (Diastolic Blood Pressure ≥100 mmHg).
• Poorly controlled type 2 diabetes (Glycated Haemoglobin A1c >8.0%).
• Use of prohibited lipid-lowering drugs within specified washout periods.
• Significant liver or kidney disease.
• Pregnancy or lactation.
• Other conditions deemed unsuitable by investigator.