Clinical trial

A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

Recruiting now · Phase 3 · 1 countries · Registry ID NCT07670884

Recruiting nowPhase 3Interventional

What this study is about

This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionChronic Management of Body Weight

Full registry criteria

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.

Treatments and study arms

HRS9531 Tablet

Drug

HRS9531 tablet.

HRS9531 Tablet Placebo

Drug

HRS9531 tablet placebo.

Primary outcomes

Percentage change from baseline in body weight after 52 weeks of treatmentAfter 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatmentAfter 52 weeks of treatment.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Nanjing Drum Tower hospital🇨🇳 Nanjing, Jiangsu, China
Yan BiPrincipal Investigator
Henan Provincial People's Hospital🇨🇳 Zhengzhou, Henan, China
Huijuan YuanContact
Huijuan YuanPrincipal Investigator