A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease
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 (ASCVD)
Fujian Shengdi Pharmaceutical Co., Ltd.
9,262 participants
May 29, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria2
- Diagnosed with atherosclerotic cardiovascular disease (ASCVD), and the course of the disease exceeds 3 months
- The body mass index (BMI) at the time of screening was ≥24.0 kg/m ². Patients with type 2 diabetes have a BMI of ≥22.0 kg/m ²
Exclusion Criteria11
- Screening for myocardial infarction, acute decompensated heart failure, hospitalization due to heart failure, unstable angina pectoris, stroke or transient ischemic attack, coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, carotid or peripheral artery recanalization within 30 days prior to the screening
- Severe hypoglycemic events or recurrent hypoglycemic events occurred within one month before screening
- When screening, there are proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, and intermittent claudication
- Coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, and carotid or peripheral artery recanalization are planned to be performed during the trial
- Those with a history of acute or chronic pancreatitis, acute cholecystitis, or symptomatic or treatment-requiring gallbladder diseases
- Any malignant tumor of the organ system has occurred within the past five years, regardless of whether there is evidence of local recurrence or metastasis, except for cured local cutaneous basal cell carcinoma and cervical carcinoma in situ
- Pregnant or lactating women, or participants with fertility who are unwilling to take effective contraceptive measures
- Those who have had any previous conditions that affected gastric emptying or have undergone gastrointestinal surgery
- Diagnosed or suspected as type 1 diabetes, special type diabetes or secondary diabetes
- Acute complications of diabetes occurred within one month before screening
- There are endocrine diseases that may significantly affect weight
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
HRS9531 Dose 1 , subcutaneous injection
HRS9531 placebo Dose 1, subcutaneous injection
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07551492