Actively Recruiting
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Participants With Atherosclerotic Cardiovascular Disease
Led by Fujian Shengdi Pharmaceutical Co., Ltd. · Updated on 2026-06-05
9262
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with atherosclerotic cardiovascular disease for more than 3 months
- Body mass index (BMI) of 24.0 kg/m² or higher; for patients with type 2 diabetes, BMI of 22.0 kg/m² or higher
- Age 18 years or older
You will not qualify if you...
- Recent heart attack, acute heart failure, unstable angina, stroke, transient ischemic attack, or related heart procedures within 30 days before screening
- Severe or repeated low blood sugar events within one month before screening
- Presence of certain eye conditions needing treatment, diabetic foot ulcers, painful neuropathy, or intermittent claudication at screening
- Planned heart or artery procedures during the trial
- History of pancreatitis, cholecystitis, or gallbladder diseases needing treatment
- Any malignant tumor within past five years except certain cured skin or cervical cancers
- Pregnancy, breastfeeding, or unwillingness to use contraception
- Prior conditions affecting stomach emptying or gastrointestinal surgery
- Diagnosed or suspected type 1 diabetes or secondary diabetes
- Recent acute diabetes complications within one month before screening
- Endocrine diseases that may significantly affect weight
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately up to 61 months
Participants receive subcutaneous injections of HRS9531 or placebo and are monitored for efficacy and safety.
Trial Site Locations
Total: 1 location
1
Fuwai Hospital, CAMS&PUMC
Beijing, Beijing Municipality, China, 100037
Actively Recruiting
Research Team
S
Sheng Qi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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