A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease

NCT07551492 | Not Yet Recruiting Phase 3

• 1 other identifier: HRS9531-310
• Study Type: interventional
• Target: 9,262
• Locations: 1 country
• Sites: 1

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.

Conditions

Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• The time from randomization to the first occurrence of the MACE-3 composite endpoint

  approximately up to 61 months of treatment

Secondary Outcomes (24)

• 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；

Study Arms (2)

HRS9531 Group A

EXPERIMENTAL

Drug: HRS9531

HRS9531 placebo Group B

PLACEBO COMPARATOR

Drug: HRS9531 placebo

Interventions

HRS9531 DRUG

HRS9531 Dose 1 , subcutaneous injection

HRS9531 Group A

HRS9531 placebo DRUG

HRS9531 placebo Dose 1, subcutaneous injection

HRS9531 placebo Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fujian Shengdi Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Atherosclerosis

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Kefei Dou

  Chinese Academy of Medical Sciences, Fuwai Hospital

  PRINCIPAL INVESTIGATOR

• Xiao Wang

  Chinese Academy of Medical Sciences, Fuwai Hospital

  STUDY DIRECTOR

Central Study Contacts

Sheng Qi

CONTACT

+8613482562074; Sheng.qi@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): June 1, 2031
• Last Updated: April 24, 2026

Record last verified: 2026-04

Locations

CN (1)