Phase III Study to Evaluate the Safety and Effectiveness of SHR-1918 for Treating Adults with High Blood Triglycerides

What this Trial Is About

Researchers are studying the effects of SHR-1918 in adults with hypertriglyceridemia, a condition characterized by high levels of triglycerides in the blood. This Phase III clinical trial aims to assess both the efficacy and safety of SHR-1918 compared to a placebo. The study is randomized, double-blind, and placebo-controlled to ensure reliable results. The lead sponsor for this research is Beijing Suncadia Pharmaceuticals Co., Ltd. Participants will receive subcutaneous injections of SHR-1918 or a placebo in two different doses. The treatment will last for up to 48 weeks, with evaluations at 24 and 48 weeks to measure changes in serum triglyceride levels and other lipid markers. The study has two experimental groups receiving different doses of SHR-1918 or placebo, and participants are randomly assigned to these groups. During the study, participants will undergo regular assessments including blood tests to monitor triglycerides, LDL cholesterol, HDL cholesterol, and other lipid-related measures. Researchers will also track the proportion of participants reaching target triglyceride levels and monitor any adverse events or injection site reactions. The primary outcome is the percentage change in triglyceride levels at weeks 20 and 24. The total participation duration may last about one year, including safety monitoring and follow-up evaluations.

A Study of SHR-1918 In Participants With Hypertriglyceridemia