NCT07551492 A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease
| NCT ID | NCT07551492 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
| Condition | Atherosclerotic Cardiovascular Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 9,262 participants |
| Start Date | 2026-05-29 |
| Primary Completion | 2031-05-24 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 9,262 participants in total. It began in 2026-05-29 with a primary completion date of 2031-05-24.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Kefei Dou
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Sciences, Fuwai Hospital
Frequently Asked Questions
Who can join the NCT07551492 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atherosclerotic Cardiovascular Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07551492 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 9,262 participants.
Is NCT07551492 currently recruiting?
Yes, NCT07551492 is actively recruiting participants. Contact the research team at Sheng.qi@hengrui.com for enrollment information.
Where is the NCT07551492 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07551492 clinical trial?
NCT07551492 is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. The principal investigator is Kefei Dou at Chinese Academy of Medical Sciences, Fuwai Hospital. The trial plans to enroll 9,262 participants.