A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease
NCT07551492 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9262
Last updated 2026-04-24
Summary
The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached.
Conditions
Interventions
- DRUG
-
HRS9531
HRS9531 Dose 1 , subcutaneous injection
- DRUG
-
HRS9531 placebo
HRS9531 placebo Dose 1, subcutaneous injection
Sponsors & Collaborators
-
Fujian Shengdi Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Kefei Dou · Chinese Academy of Medical Sciences, Fuwai Hospital
-
Xiao Wang · Chinese Academy of Medical Sciences, Fuwai Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-31
- Primary Completion
- 2031-05-31
- Completion
- 2031-06-30
Countries
- China
Study Locations
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