Phase III Study of HRS9531 Injection to Treat Atherosclerotic Cardiovascular Disease in Adults

What this Trial Is About

Researchers are evaluating the impact of HRS9531 on major adverse cardiovascular events MACE in patients with atherosclerotic cardiovascular disease ASCVD. This phase III study uses an event-driven design and will conclude when the planned number of primary endpoint events is reached. The goal is to assess the efficacy and safety of HRS9531 injection compared with placebo in this patient population. Participants are randomly assigned to receive either HRS9531 or a placebo, both given as subcutaneous injections. The study is double-blind and takes place at multiple centers. Treatment duration may extend up to approximately 61 months, during which the time to various cardiovascular events and other health outcomes will be monitored. During the study, researchers will track the time from randomization to the first occurrence of the primary composite endpoint involving major cardiovascular events. Secondary measures include heart failure, kidney disease, limb events, and mortality, along with body weight, blood sugar, blood lipids, blood pressure, kidney function, and inflammatory markers. Safety will be closely monitored throughout the trial, which may last up to five years for each participant.

A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease