Evaluation of SYH2053 Injection for Adults with Heterozygous Familial Hypercholesterolemia HeFH A Phase III Randomized, Double-Blind, Placebo-Controlled Study

What this Trial Is About

Heterozygous Familial Hypercholesterolemia HeFH is a genetic disorder causing very high levels of low-density lipoprotein cholesterol LDL-C and increasing the risk of heart disease. This research evaluates the SYH2053 Injection in patients with HeFH through a multicenter, randomized, double-blind, placebo-controlled Phase III trial. The study aims to assess how well SYH2053 works, its safety, and immune response when used alongside standard lipid-lowering treatment and a low-fat diet. Participants receive either the SYH2053 Injection or a matching placebo by subcutaneous injection. The study includes a screening period to determine eligibility, followed by a treatment period where injections are given. Participants continue their background statin therapy and low-fat diet during the trial. Throughout the study, participants undergo fasting blood tests to measure LDL-C levels at the start and again at Day 330, which is the primary outcome measure. Researchers also monitor safety, immunogenicity, and adherence to treatment. The trial lasts several months, concluding with a final assessment of cholesterol changes and participant health.

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