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.
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.
HoFH or suspected HoFH.
Use of medications that significantly affect LDL-C levels.
Hypersensitivity or suspected allergy to oligonucleotide drugs or excipients of the investigational product.
Major adverse cardiovascular events (MACE) within 180 days before signing the ICF; history of hemorrhagic stroke; or extreme-risk ASCVD at screening.
Parallel
SYH2053 Injection
DrugAdministered by subcutaneous injection.
Placebo Injection
DrugAdministered by subcutaneous injection. The placebo is identical to SYH2053 Injection in appearance.
Percentage Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330
Fasting LDL-C is measured by a central laboratory.
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