A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atheroscler… (NCT07551492) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease
China9,262 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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
What they're measuring
1
The time from randomization to the first occurrence of the MACE-3 composite endpoint
Timeframe: approximately up to 61 months of treatment