HRS9531 for atherosclerotic cardiovascular disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, event-driven trial assessing the efficacy and safety of HRS9531 in adults with atherosclerotic cardiovascular disease. Participants are assigned to receive HRS9531 or a placebo and the study ends once a predefined number of primary endpoint events occurs. Key eligibility includes ASCVD with BMI criteria and stable medical history, while exclusions focus on recent acute cardiovascular events and certain diabetic or ophthalmic conditions. The trial is conducted at selected centers in Beijing, sponsored by Fujian Shengdi Pharmaceutical Co., with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diagnosed with atherosclerotic cardiovascular disease (ASCVD)
2. 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:

1. 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
2. Severe hypoglycemic events or recurrent hypoglycemic events occurred within one month before screening
3. When screening, there are proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers
4. Coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, and carotid or peripheral artery recanalization are planned to be performed during the trial
5. Those with a history of acute or chronic pancreatitis, acute cholecystitis, or symptomatic or treatment-requiring gallbladder diseases
6. 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
7. Pregnant or lactating women, or participants with fertility who are unwilling to take effective contraceptive measures
8. Those who have had any previous conditions that affected gastric emptying or have undergone gastrointestinal surgery
9. Diagnosed or suspected as type 1 diabetes, special type diabetes or secondary diabetes
10. Acute complications of diabetes occurred within one month before screening
11. There are endocrine diseases that may significantly affect weight

Where it's running

• Fuwai Hospital, CAMS&PUMC
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Principal investigator: Kefei Dou — Chinese Academy of Medical Sciences, Fuwai Hospital
• Study coordinator: Sheng Qi
• Email: Sheng.qi@hengrui.com
• Phone: +8613482562074

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.