NCT07465263

A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)

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: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical trial conducted in patients with heterozygous familial hypercholesterolemia. It aims to evaluate the efficacy, safety, and immunogenicity of SYH2053 Injection when administered on the basis of background lipid-lowering therapy and a low-fat diet. The study consists of a screening period and a treatment period.

Conditions

• Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions

Type	Name	Description
DRUG	SYH2053 Injection	Administered by subcutaneous injection.
DRUG	Placebo Injection	Administered by subcutaneous injection. The placebo is identical to SYH2053 Injection in appearance.

Timeline

• Start date: 2026-03-31
• Primary completion: 2028-02-28
• Completion: 2028-05-31
• First posted: 2026-03-11
• Last updated: 2026-03-19