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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

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

Treatment groups

135 Participants
are divided into 2 treatment groups

Locations

This trial has no locations