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CompletedPhase 3

To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese

Efficacy and Safety of HRS9531 in Overweight or Obese Participants: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

Asset

HRS9531

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

567

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥28

Primary endpoints

Body weight, % change≥5% weight-loss responders

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 IDNCT06396429
Org study IDHRS9531-301

Timeline

Milestones

Study first posted2024-05-02actual
Study start2024-05-13actual
Primary completion2025-07-07actual
Study completion2025-07-07actual
Last update posted2025-07-11actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Able and willing to provide a written informed consent.

2. Male or female subjects, ≥18 years of age at the time of signing informed consent.

3. At screening visit, BMI≥28.0 Kg/m2, or ≥24 Kg/m2 with at least one weight-related complication, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, and nonalcoholic fatty liver disease.

4. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.

5. Fertile male and female subjects (including partners) have no plans to have children and agree to use effective contraception within 2 months after signing the informed consent form and the last medication, and fertile female or male subjects have no plans to donate eggs/sperm; Fertile female subjects tested negative for regnancy within the first 3 days of randomization and were not lactating.

Exclusion criteria

1. Presence of clinically significant lab results at screening visit;

2. Uncontrollable hypertension;

3. PHQ-9 score ≥15;

4. Medical history or illness that affects your weight;

5. History of diabetes;

6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;

7. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;

8. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin、 in-situ cancer of the cervix and in-situ cancer of the prostate;

9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;

10. Known or suspected history of alcohol and/or substance abuse or drug abuse;

11. History of acute or chronic hepatitis or other serious liver disease other than alcoholic fatty liver disease.

12. Have received or plan to have an organ or bone marrow transplant during the study.

13. The presence of any blood disorders that may interfere with HbA1c testing.

14. Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned during the study.

15. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;

16. Weight loss surgery or endoscopic and/or medical device-based weight loss therapy is planned for or during the study period;

17. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;

18. Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.

19. Surgery is planned during the tria;

20. Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process;

21. In the investigator's judgment, there are circumstances (medical, psychological, social, or geographical factors, etc.) that affect subject safety or any other conditions that interfere with the evaluation of the test results.

Endpoints (18)

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

Weight & body composition
7
Cardiometabolic biomarkers
6
Glycemic / diabetes
3
Patient-reported / QoL
1
Safety / tolerability / PK
1

Weight & body composition

7 endpoints
Primary/protocol endpoint

Percentage change from baseline in weight after 48 weeks of treatment

Time frame:Baseline, Week 48

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Proportion of subjects with weight loss of≥5% from baseline after 48 weeks of treatment

Time frame:Week 48

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects with weight loss of ≥10% from baseline after 48 weeks of treatment

Time frame:Week 48

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects with weight loss of ≥15% from baseline after 48 weeks of treatment

Time frame:Week 48

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference after 48 weeks of treatment

Time frame:Baseline, Week 48

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in weight after 48 weeks of treatment

Time frame:Baseline, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in BMI after 48 weeks of treatment

Time frame:Baseline, Week 48

BMI, change

change from baseline, improvement

Glycemic / diabetes

3 endpoints
Secondary/protocol endpoint

Change from baseline in fasting plasma glucose (FPG) after 48 weeks of treatment

Time frame:Baseline, Week 48

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from baseline in glycosylated haemoglobin (HbA1c) after 48 weeks of treatment

Time frame:Baseline, Week 48

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from baseline in fasting serum insulin after 48 weeks of treatment

Time frame:Baseline, Week 48

change from baseline, improvement

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Change from baseline in systolic blood pressure after 48 weeks of treatment

Time frame:Baseline, Week 48

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change from baseline in diastolic blood pressure after 48 weeks of treatment

Time frame:Baseline, Week 48

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change from baseline in Total Cholesterol after 48 weeks of treatment

Time frame:Baseline, Week 48

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change from baseline in Low Density Lipoprotein (LDL) Cholesterol after 48 weeks of treatment

Time frame:Baseline, Week 48

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change from baseline in Triglycerides after 48 weeks of treatment

Time frame:Baseline, Week 48

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from baseline in High Density Lipoprotein (HDL) Cholesterol after 48 weeks of treatment

Time frame:Baseline, Week 48

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Change in scores of SF-36 V2 from baseline after 48 weeks of treatment

Time frame:Baseline, Week 48

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of AEs during the trial

Time frame:week 0 to week 52

Treatment-emergent AEs (any)

event count, event

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.