Study of SHR-1918 Treatment for Adults with High Cholesterol Not Controlled by Statins and PCSK9 Inhibitors

What this Trial Is About

Researchers are evaluating the effectiveness and safety of a drug called SHR-1918 in adults with hypercholesterolemia who have not achieved adequate lipid control despite using statins plus PCSK9 inhibitors. The study focuses on how SHR-1918 impacts cholesterol levels and lipid control over periods of 12 and 24 weeks. This is a randomized, double-blind, placebo-controlled Phase IIIII trial conducted by Beijing Suncadia Pharmaceuticals Co., Ltd. Participants will receive either the SHR-1918 injection or a placebo injection. The study compares these two groups over 24 weeks, with the primary efficacy and safety assessments occurring at 12 and 24 weeks of treatment. The trial uses a parallel study design where participants are randomly assigned to one of the two groups and monitored throughout the treatment period. During the study, participants will undergo regular evaluations of their low-density lipoprotein cholesterol LDL-C levels along with other lipid markers such as non-high-density lipoprotein cholesterol, triglycerides, total cholesterol, and apolipoproteins. Safety is closely monitored by tracking adverse events and injection site reactions. The study lasts for up to 24 weeks of treatment, with primary outcome measures focusing on percentage changes in LDL-C at 12 and 24 weeks compared to baseline.

A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors