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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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 endpointsPercentage 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
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
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
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
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
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
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 endpointsChange from baseline in blood pressure after 26 weeks of treatment
Time frame:after 26 weeks of treatment
change from baseline, improvement
Change from baseline in blood lipid after 26 weeks of treatment
Time frame:after 26 weeks of treatment
change from baseline, improvement
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 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.