A Study to Evaluate the Efficacy and Safety of JS002 in Patients With Heterozygous Familial Hypercholesterolemia (HeFH).

A randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of JS002 in patients with heterozygous familial hypercholesterolemia. 120 subjects are planned to be enrolled. Each subject is required a maximum of 6 weeks of screening, 24 weeks of treatment, and 8 weeks of follow-up. To evaluate the lipid-lowering efficacy of subcutaneous injection of JS002 at 24 weeks compared with placebo in heterozygous familial hypercholesterolemia patients under optimized lipid lowing therapy . Subjects meeting the study inclusion criteria will be randomly assigned in a 2:1:2:1 ratio to JS002 150 mg Q2W or JS002 450 mg Q4W or matched placebo to receive the study drug (JS002) or placebo subcutaneously for 24 weeks.

treatment cohorts: JS002 150mg Cohort:JS002 150mg or placebo treatment(JS002 :Placebo=2:1) Q2W JS002 450mg Cohort:JS002 450mg or placebo treatment(JS002 :Placebo=2:1)Q4W

Inclusion criteria

• Signed informed consent.
• Males and females ≥ 18 to ≤ 80 years of age
• DLCN>8 in HeFH
• Stable lipid-lowering therapies for at least 4 weeks
• Patients with ASCVD LDL cholesterol≥1.4mmol/L at screening Patients without ASCVD LDL cholesterol≥2.6mmol/L at screening
• Triglyceride≤4.5 mmol/L（400 mg/dL）;

Exclusion criteria

• HoFH or meet the diagnostic criteria of HoFH
• New York Heart Association (NYHA) class III or IV or last known left ventricular ejection fraction < 30%
• History of uncontrolled arrhythmia within 90 days
• Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 90 days of randomization
• Planned cardiac surgery or revascularization.
• Uncontrolled diabetes mellitius (HbA1c>8.0%）.
• Uncontrolled hypertension.
• Other conditions that the researchers considered inappropriate to participate in the study.