GLP-1 Peptide Atlas, by Delfa

Not yet recruitingPhase 3

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)

Lead sponsor

Fujian Shengdi Pharmaceutical Co., Ltd.

Asset

HRS9531

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

9,262

estimated

Study population

Cardiovascular disease, Obesity / overweight

Key I/E criterion

•BMI ≥24

Primary endpoint

•3-point MACE (Cardiovascular death, Non-fatal MI, Non-fatal stroke)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07551492

Org study IDHRS9531-310

Timeline

Milestones

Study first posted2026-04-24actual

Last update posted2026-04-24actual

Study start2026-05estimated (month precision)

Primary completion2031-05estimated (month precision)

Study completion2031-06estimated (month precision)

Assets

Investigational agents

HRS9531

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (25)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiovascular outcomes

Renal / kidney

Cardiometabolic biomarkers

Heart failure

Weight & body composition

Glycemic / diabetes

Safety / tolerability / PK

Cardiovascular outcomes

8 endpoints

Primary/protocol endpoint

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

Time frame:approximately up to 61 months of treatment

3-point MACE

time to event, event

componentsCardiovascular death, Non-fatal MI, Non-fatal stroke

Secondary/protocol endpoint

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

Time frame:approximately up to 61 months of treatment

4-point MACE

time to event, event

Secondary/protocol endpoint

Time to the first occurrence of the extended MACE composite endpoint

Time frame:approximately up to 61 months of treatment

Expanded / custom MACE composite

time to event, event

Secondary/protocol endpoint

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

Time frame:approximately up to 61 months of treatment；

MALE composite (major adverse limb events)

time to event, event

componentsAcute limb ischemia, Peripheral revascularization, Major amputation

Secondary/protocol endpoint

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；

3-point MACE

time to event, event

Secondary/protocol endpoint

Time when all-cause death occurs；

Time frame:approximately up to 61 months of treatment；

All-cause death

time to event, event

SNOMED 419620001

Secondary/protocol endpoint

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

Time frame:approximately up to 61 months of treatment；

Acute limb ischemia

time to event, event

Secondary/protocol endpoint

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

Time frame:approximately up to 61 months of treatment

time to event, event

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change from baseline in body weight;

Time frame:From randomization to 104 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waistline;

Time frame:From randomization to 104 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Change from baseline in glycosylated hemoglobin;

Time frame:From randomization to 104 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Heart failure

3 endpoints

Secondary/protocol endpoint

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

Time frame:approximately up to 61 months of treatment

Heart-failure composite

time to event, event

SNOMED 84114007

Secondary/protocol endpoint

Time to the first hospitalization due to heart failure；

Time frame:approximately up to 61 months of treatment；

Heart-failure hospitalization

time to event, event

SNOMED 84114007

Secondary/protocol endpoint

Time to the first emergency heart failure visit；

Time frame:approximately up to 61 months of treatment；

Urgent heart-failure visit

time to event, event

SNOMED 84114007

Renal / kidney

6 endpoints

Secondary/protocol endpoint

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

Time frame:approximately up to 61 months of treatment

Custom renal composite

time to event, event

Secondary/protocol endpoint

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

Time frame:approximately up to 61 months of treatment；

Custom renal composite

time to event, event

LOINC 98979-8

Secondary/protocol endpoint

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

Time frame:approximately up to 61 months of treatment；

End-stage renal disease

time to event, event

SNOMED 46177005

Secondary/protocol endpoint

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

Time frame:approximately up to 61 months of treatment；

Kidney-replacement therapy

time to event, event

Secondary/protocol endpoint

The time when renal death occurs；

Time frame:approximately up to 61 months of treatment；

Renal death

time to event, event

Secondary/protocol endpoint

Change from baseline in glomerular filtration;

Time frame:From randomization to 104 weeks

eGFR, change

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints

Secondary/protocol endpoint/low confidence

Change from baseline in blood lipid parameter;

Time frame:From randomization to 104 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in blood pressure;

Time frame:From randomization to 104 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in Uric Acid;

Time frame:From randomization to 104 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in hsCRP;

Time frame:From randomization to 104 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Incidence and severity of adverse events ;

Time frame:Approximately 61 months

Treatment-emergent AEs (any)

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.