A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
Lead sponsor
Asset
HRS9531
GLP-1 / GIP dual
Listed sites
2
Recruiting sites
-
Estimated enrollment
425
Study population
Obesity / overweight
Eligibility highlights
•BMI ≥28
Primary endpoints
•Body weight after 52 weeks of treatment•Weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Male or female subjects, 18-75 years of age at the time of signing informed consent;
2. At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity;
3. 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;
4. Able and willing to provide a written informed consent.
Exclusion criteria
1. 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;
2. Uncontrollable severe hypertension;
3. PHQ-9 score ≥ 15;
4. Medical history or illness that affects body weight;
5. History of diabetes;
6. Acute or chronic hepatitis;
7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years;
9. Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening;
10. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired;
11. Use of any medication or treatment that may have caused significant weight change within 90 days;
12. History of bariatric surgery;
13. Known or suspected hypersensitivity to trial product(s) or related products;
14. History of alcohol and/or substance abuse or drug abuse;
15. History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
16. Surgery is planned during the trial;
17. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Endpoints (16)
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
8 endpointsPercentage change from baseline in body weight after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
percent change from baseline, improvement
Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
threshold achievement, improvement
Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
threshold achievement, improvement
Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
threshold achievement, improvement
Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
threshold achievement, improvement
Change from baseline in waist circumference after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
change from baseline, improvement
Change from baseline in body weight after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
change from baseline, improvement
Change from baseline in BMI (Body Mass Index) after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
change from baseline, improvement
Glycemic / diabetes
2 endpointsChange from baseline in fasting plasma glucose after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
change from baseline, improvement
Change from baseline in fasting serum insulin after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
change from baseline, improvement
Cardiometabolic biomarkers
3 endpointsChange from baseline in blood pressure after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
change from baseline, improvement
Change from baseline in blood lipid after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
change from baseline, improvement
Change from baseline in blood uric acid after 52 weeks of treatment
Time frame:After 52 weeks of treatment.
change from baseline, improvement
Safety / tolerability / PK
2 endpointsNumber of treatment serious adverse events (SAEs) within 57 weeks
Time frame:Within 57 weeks.
event count, event
Number of treatment adverse events (AEs) within 57 weeks
Time frame:Within 57 weeks.
event count, event
Other (unclassified)
1 endpointChange from baseline in glycosylated hemoglobin after 52 weeks of treatment
Time frame:After 52 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 6, 2026 snapshot.