QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia (HeFH)

Evaluation of Efficacy and Safety of QLC7401 in Participants With Heterozygous Familial Hypercholesterolemia on a Stable Lipid-lowering Therapy: 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 Treatment in adults with Heterozygous Familial Hypercholesterolemia on a stable 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 18-80 years (inclusive)
• Participants diagnosed with heterozygous familial hypercholesterolemia by Dutch Lipid Clinic
• Network criteria or genetic testing;
• Serum low density lipoprotein cholesterol ≥2.6 millimoles (mmol)/liter (L) at screening.
• Fasting triglyceride <4.5 mmol/L at screening.
• Participants on lipid-lowering therapies should be on a stable dose for ≥4 weeks before screening with no planned medication or dose change during study participation.
• Estimated glomerular filtration Rate (eGFR) >30 mL/min/1.73 m².
• Willing to provide informed consent.

Exclusion Criteria:

• New York Heart Association (NYHA) class III or IV heart failure.
• Uncontrolled cardiac arrhythmia.
• Cardiovascular Diseases within 3 months.
• Uncontrolled hypertension.
• Poorly controlled type 2 diabetes.
• Significant liver or kidney disease.
• Pregnancy or lactation.
• Other conditions deemed unsuitable by investigator.