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

Recruiting Phase 3 Interventional Study
Heterozygous Familial Hypercholesterolemia (HeFH)
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
135 (estimated)
Sponsor
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female participants ≥18 years of age. 2. HeFH. 3. Stable moderate-to-high intensity statin therapy (± cholesterol absorption inhibitors) . 4. Maintained a low-fat diet for ≥4 weeks before signing the ICF. 5. Fasting LDL-C at screening ≥ 2.6 mmol/L or ≥ 1.4 mmol/L with…
Contacts

Clinical Trials Information Group officer

0311-69085587

ctr-contact@cspc.cn

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