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CompletedPhase 2

Efficacy and Safety of HRS9531 Tablet in Obese Subjects

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Tablet in Obese Subjects

Asset

HRS9531

Oral · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

Enrollment

166

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≤40

Primary endpoint

Body weight, % change

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 IDNCT06841445
Org study IDHRS9531-T-201

Timeline

Milestones

Study first posted2025-02-24actual
Study start2025-04-07actual
Primary completion2026-01-08actual
Study completion2026-01-08actual
Last update posted2026-04-03actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

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

2. Male or female subjects, 18-65 years of age at the time of signing informed consent;

3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;

4. Diet and exercise control for at least 3 months before screening visit, and the weight change does not exceed 5% within the last 3 months;

5. Non-pregnant or lactating women. Fertile male and female (including partners) agree to use highly effective contraceptive methods.

Exclusion criteria

1. Uncontrollable hypertension;

2. Presence of - clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;

3. PHQ-9 score ≥15;

4. Medical history or illness that affects body weight;

5. History of diabetes;

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

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

8. Any organ-system malignancies developed within 5 years;

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

10. History of alcohol and/or substance abuse or drug abuse;

11. Use of any medication or treatment that may have caused significant weight change within 3 months;

12. History of bariatric surgery;

13. Known or suspected hypersensitivity to trial product(s) or related products;

14. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;

15. Surgery is planned during the trial;

16. Mentally incapacitated or speech-impaired;

17. Acute or chronic hepatitis;

18. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Endpoints (10)

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
3

Weight & body composition

7 endpoints
Primary/protocol endpoint

Percentage Change from baseline in body weight after 26 weeks of treatment

Time frame:after 26 weeks of treatment

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of subjects with weight loss of ≥5% from baseline in body weight after 26 weeks of treatment

Time frame:after 26 weeks of treatment

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects with weight loss of ≥10% from baseline in body weight after 26 weeks of treatment

Time frame:after 26 weeks of treatment

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of subjects with weight loss of ≥15% from baseline in body weight after 26 weeks of treatment

Time frame:after 26 weeks of treatment

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body weight after 26 weeks of treatment

Time frame:after 26 weeks of treatment

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in waist circumference after 26 weeks of treatment

Time frame:after 26 weeks of treatment

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in BMI after 26 weeks of treatment

Time frame:after 26 weeks of treatment

BMI, change

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Change from baseline in blood pressure after 26 weeks of treatment

Time frame:after 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from baseline in blood lipid after 26 weeks of treatment

Time frame:after 26 weeks of treatment

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in blood uric acid after 26 weeks of treatment

Time frame:after 26 weeks of treatment

change from baseline, improvement

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.