Phase 3 Study of SHR-1918 Drug to Treat Hyperlipidemia by Lowering LDL Cholesterol and Triglycerides

What this Trial Is About

Researchers are evaluating the effectiveness and safety of SHR-1918 in lowering serum low-density lipoprotein cholesterol LDL-C and total triglycerides TG in patients with hyperlipidemia, compared to a placebo. The study also aims to assess SHR-1918s impact on other lipid markers in patients with mixed hyperlipidemia. This is a Phase III, multicenter, randomized, double-blind, placebo-controlled clinical trial sponsored by Beijing Suncadia Pharmaceuticals Co., Ltd. Participants are assigned randomly to receive either a low or high dose of SHR-1918 or matching placebo. The treatment period lasts 24 weeks, during which changes in LDL-C, TG, and other lipid indicators are measured. The study includes an additional follow-up period up to 52 weeks to assess safety outcomes such as adverse events, injection site reactions, and major cardiovascular events. Throughout the trial, participants undergo regular assessments of blood lipid levels including LDL-C, triglycerides, non-HDL cholesterol, total cholesterol, apolipoproteins, and lipoproteina at baseline, week 24, and week 48. Safety is monitored continuously up to week 52 with attention to cardiovascular events and injection site reactions. The study duration allows for comprehensive evaluation of both efficacy and safety over nearly a year of participation.

A Trial to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hyperlipidemia