HRS9531 tablets for weight loss in adults who are overweight or obese
Tests HRS9531 tablets against placebo for weight loss in overweight or obese adults.
Plain-language title generated from the registry record
Registry title: A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
Key facts
- Where
- Nanjing and Zhengzhou, ChinaSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07670884, who can take part
Where in China
- Nanjing Drum Tower hospitalNanjing, ChinaTaking people
- Henan Provincial People's HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fujian Shengdi Pharmaceutical Co., Ltd.
- Trial code
- NCT07670884
- Record updated
- 13 August 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Male or female subjects, 18-75 years of age at the time of signing informed consent; At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity; 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; Able and willing to provide a written informed consent.
Exclusion: 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; History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening; Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening; Use of any medication or treatment that may have caused significant weight change within 90 days; History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; Surgery is planned during the trial; Uncontrollable severe hypertension; Medical history or illness that affects body weight; History of diabetes; Acute or chronic hepatitis; Any organ-system malignancies developed within 5 years; Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired; History of bariatric surgery; Known or suspected hypersensitivity to trial product(s) or related products; History of alcohol and/or substance abuse or drug abuse; The investigators determined that other conditions were inappropriate for participation in this clinical trial; PHQ-9 score ≥ 15.