A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterol… (NCT07465263) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study to Evaluate the SYH2053 Injection in Patients With Heterozygous Familial Hypercholesterolemia (HeFH)
135 participantsStarted 2026-03-31
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female participants ≥18 years of age.
✓. Maintained a low-fat diet for ≥4 weeks before signing the ICF.
✓. Fasting LDL-C at screening ≥ 2.6 mmol/L or ≥ 1.4 mmol/L without ASCVD or with ASCVD.
✓. Fasting TG ≤5.6 mmol/L at screening.
Exclusion criteria
✕. 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.
✕. Uncontrolled (by medication/ablation) or severe arrhythmias within 180 days before signing the ICF.
✕. NYHA Class III-IV heart failure or LVEF \<40% within 1 year before signing ICF or at screening.
✕. Type 1 diabetes.
✕
What they're measuring
1
Percentage Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Day 330