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NCT Number: NCT07551492

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

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.

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Key information

Conditions

Atherosclerotic Cardiovascular Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Fuwai Hospital, CAMS&PUMC

Beijing, Beijing Municipality, 100037, China

Location status: Recruiting

Location contact

Kefei Dou

PRINCIPAL_INVESTIGATOR

Xiao Wang

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

HRS9531

Drug

HRS9531 Dose 1 , subcutaneous injection

HRS9531 placebo

Drug

HRS9531 placebo Dose 1, subcutaneous injection

Primary outcomes

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

    Time frame: approximately up to 61 months of treatment

Secondary outcomes

  1. Time to the first occurrence of the MACE-4 composite endpoint

    Time frame: approximately up to 61 months of treatment

  2. Time to the first occurrence of the extended MACE composite endpoint

    Time frame: approximately up to 61 months of treatment

  3. Time to the first occurrence of the composite endpoint of heart failure；

    Time frame: approximately up to 61 months of treatment

  4. Time to the first occurrence of the composite endpoint of kidney disease；

    Time frame: approximately up to 61 months of treatment

  5. Time to the first occurrence of the composite endpoint of major adverse limb events；

    Time frame: approximately up to 61 months of treatment；

  6. 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；

  7. Time when all-cause death occurs；

    Time frame: approximately up to 61 months of treatment；

  8. Time to the first hospitalization due to heart failure；

    Time frame: approximately up to 61 months of treatment；

  9. Time to the first emergency heart failure visit；

    Time frame: approximately up to 61 months of treatment；

  10. Time when the first persistent eGFR decreased by ≥50% from baseline；

    Time frame: approximately up to 61 months of treatment；

  11. Time when persistent eGFR < 15 mL/min/1.73m2 occurred for the first time；

    Time frame: approximately up to 61 months of treatment；

  12. Time to first entering chronic renal replacement therapy (dialysis or kidney transplantation) ；

    Time frame: approximately up to 61 months of treatment；

  13. The time when renal death occurs；

    Time frame: approximately up to 61 months of treatment；

  14. Time to hospitalization for the first occurrence of acute limb ischemia；

    Time frame: approximately up to 61 months of treatment；

  15. Time to hospitalization for the first occurrence of unplanned chronic limb ischemia；

    Time frame: approximately up to 61 months of treatment

  16. Incidence and severity of adverse events ;

    Time frame: Approximately 61 months

  17. Change from baseline in body weight;

    Time frame: From randomization to 104 weeks

  18. Change from baseline in waistline;

    Time frame: From randomization to 104 weeks

  19. Change from baseline in glycosylated hemoglobin;

    Time frame: From randomization to 104 weeks

  20. Change from baseline in blood lipid parameter;

    Time frame: From randomization to 104 weeks

  21. Change from baseline in blood pressure;

    Time frame: From randomization to 104 weeks

  22. Change from baseline in glomerular filtration;

    Time frame: From randomization to 104 weeks

  23. Change from baseline in Uric Acid;

    Time frame: From randomization to 104 weeks

  24. Change from baseline in hsCRP;

    Time frame: From randomization to 104 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Sheng Qi

CONTACT

[email protected]

+8613482562074

Sponsors and collaborators

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Apr 24, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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