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

September 2, 2026 updated by: Fujian Shengdi Pharmaceutical Co., Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
9262

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The time from randomization to the first occurrence of the MACE-3 composite endpoint
Time Frame: approximately up to 61 months of treatment
approximately up to 61 months of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Time to the first occurrence of the MACE-4 composite endpoint
Time Frame: approximately up to 61 months of treatment
approximately up to 61 months of treatment
Time to the first occurrence of the extended MACE composite endpoint
Time Frame: approximately up to 61 months of treatment
approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of heart failure；
Time Frame: approximately up to 61 months of treatment
approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of kidney disease；
Time Frame: approximately up to 61 months of treatment
approximately up to 61 months of treatment
Time to the first occurrence of the composite endpoint of major adverse limb events；
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
Time when each component event of the MACE-3 composite endpoint occurred for the first time
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
Time when all-cause death occurs；
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
Time to the first hospitalization due to heart failure；
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
Time to the first emergency heart failure visit；
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
Time when the first persistent eGFR decreased by ≥50% from baseline；
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
Time when persistent eGFR < 15 mL/min/1.73m2 occurred for the first time；
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
Time to first entering chronic renal replacement therapy (dialysis or kidney transplantation) ；
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
The time when renal death occurs；
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
Time to hospitalization for the first occurrence of acute limb ischemia；
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
Time to hospitalization for the first occurrence of unplanned chronic limb ischemia；
Time Frame: approximately up to 61 months of treatment
approximately up to 61 months of treatment
Incidence and severity of adverse events ;
Time Frame: Approximately 61 months
Approximately 61 months
Change from baseline in body weight;
Time Frame: From randomization to 104 weeks
From randomization to 104 weeks
Change from baseline in waistline;
Time Frame: From randomization to 104 weeks
From randomization to 104 weeks
Change from baseline in glycosylated hemoglobin;
Time Frame: From randomization to 104 weeks
From randomization to 104 weeks
Change from baseline in blood lipid parameter;
Time Frame: From randomization to 104 weeks
From randomization to 104 weeks
Change from baseline in blood pressure;
Time Frame: From randomization to 104 weeks
From randomization to 104 weeks
Change from baseline in glomerular filtration;
Time Frame: From randomization to 104 weeks
From randomization to 104 weeks
Change from baseline in Uric Acid;
Time Frame: From randomization to 104 weeks
From randomization to 104 weeks
Change from baseline in hsCRP;
Time Frame: From randomization to 104 weeks
From randomization to 104 weeks
The time to the first unplanned revascularization event
Time Frame: approximately up to 61 months of treatment；
approximately up to 61 months of treatment；
Time when the first persistent eGFR decreased by ≥40% from baseline；
Time Frame: approximately up to 61 months of treatment
approximately up to 61 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fujian Shengdi Pharmaceutical Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 24, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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