A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase Ⅲ Clinical Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
Heterozygous Familial Hypercholesterolemia (HeFH) is an autosomal dominant disorder characterized by markedly elevated low-density lipoprotein cholesterol (LDL-C) and increased risk of atherosclerotic cardiovascular disease (ASCVD). This trial aims to evaluate the SYH2053 Injection in patients with HeFH.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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• Male or female participants ≥18 years of age.
• HeFH.
• Stable moderate-to-high intensity statin therapy (± cholesterol absorption inhibitors) .
• Maintained a low-fat diet for ≥4 weeks before signing the ICF.
• Fasting LDL-C at screening ≥ 2.6 mmol/L or ≥ 1.4 mmol/L without ASCVD or with ASCVD.
• Fasting TG ≤5.6 mmol/L at screening.
Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Contact Information
Primary
Clinical Trials Information Group officer
ctr-contact@cspc.cn
0311-69085587
Time Frame
Start Date: 2026-03-31
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 135
Treatments
Experimental: SYH2053
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.