NCT07670884 A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects
| NCT ID | NCT07670884 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fujian Shengdi Pharmaceutical Co., Ltd. |
| Condition | Chronic Management of Body Weight |
| Study Type | INTERVENTIONAL |
| Enrollment | 675 participants |
| Start Date | 2026-07-24 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 675 participants in total. It began in 2026-07-24 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07670884 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Chronic Management of Body Weight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07670884 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 675 participants.
Is NCT07670884 currently recruiting?
Yes, NCT07670884 is actively recruiting participants. Contact the research team at danli.zhang@hengrui.com for enrollment information.
Where is the NCT07670884 trial being conducted?
This trial is being conducted at Zhengzhou, China, Nanjing, China.
Who is sponsoring the NCT07670884 clinical trial?
NCT07670884 is sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.. The trial plans to enroll 675 participants.