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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- SYH2053 Injection
- Placebo Injection