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)

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.

Study Overview

• Status: Recruiting
• Conditions: Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Drug: HRS9531; Drug: HRS9531 placebo

• Study Type: Interventional
• Enrollment (Estimated): 9262
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sheng Qi; Phone Number: +8613482562074; Email: Sheng.qi@hengrui.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100037
      • Recruiting
      • Fuwai Hospital, CAMS&PUMC
      • Principal Investigator: Kefei Dou
      • Principal Investigator: Xiao Wang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosed with atherosclerotic cardiovascular disease (ASCVD), and the course of the disease exceeds 3 months
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, and intermittent claudication
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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS9531 Group A	Drug: HRS9531; HRS9531 Dose 1 , subcutaneous injection
Placebo Comparator: HRS9531 placebo Group B	Drug: HRS9531 placebo; HRS9531 placebo Dose 1, subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The time from randomization to the first occurrence of the MACE-3 composite endpoint	approximately up to 61 months of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to the first occurrence of the MACE-4 composite endpoint	approximately up to 61 months of treatment
Time to the first occurrence of the extended MACE composite endpoint	approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of heart failure；	approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of kidney disease；	approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of major adverse limb events；	approximately up to 61 months of treatment；
Time when each component event of the MACE-3 composite endpoint occurred for the first time	approximately up to 61 months of treatment；
Time when all-cause death occurs；	approximately up to 61 months of treatment；
Time to the first hospitalization due to heart failure；	approximately up to 61 months of treatment；
Time to the first emergency heart failure visit；	approximately up to 61 months of treatment；
Time when the first persistent eGFR decreased by ≥50% from baseline；	approximately up to 61 months of treatment；
Time when persistent eGFR < 15 mL/min/1.73m2 occurred for the first time；	approximately up to 61 months of treatment；
Time to first entering chronic renal replacement therapy (dialysis or kidney transplantation) ；	approximately up to 61 months of treatment；
The time when renal death occurs；	approximately up to 61 months of treatment；
Time to hospitalization for the first occurrence of acute limb ischemia；	approximately up to 61 months of treatment；
Time to hospitalization for the first occurrence of unplanned chronic limb ischemia；	approximately up to 61 months of treatment
Incidence and severity of adverse events ;	Approximately 61 months
Change from baseline in body weight;	From randomization to 104 weeks
Change from baseline in waistline;	From randomization to 104 weeks
Change from baseline in glycosylated hemoglobin;	From randomization to 104 weeks
Change from baseline in blood lipid parameter;	From randomization to 104 weeks
Change from baseline in blood pressure;	From randomization to 104 weeks
Change from baseline in glomerular filtration;	From randomization to 104 weeks
Change from baseline in Uric Acid;	From randomization to 104 weeks
Change from baseline in hsCRP;	From randomization to 104 weeks

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Kefei Dou, Chinese Academy of Medical Sciences, Fuwai Hospital; Study Director: Xiao Wang, Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): June 1, 2031

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 22, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: HRS9531-310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No