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

NCT07465263 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2026-07-08

No results posted yet for this study

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.

Conditions

  • Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions

DRUG

SYH2053 Injection

Administered by subcutaneous injection.

DRUG

Placebo Injection

Administered by subcutaneous injection. The placebo is identical to SYH2053 Injection in appearance.

Sponsors & Collaborators

  • CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-02-28
Completion
2028-05-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07465263 on ClinicalTrials.gov