HRS9531 tablets vs placebo for weight loss in adults with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial compares HRS9531 tablets to placebo in adults with overweight or obesity. Participants will take the study drug or placebo for 52 weeks while following guidelines for diet and exercise. The study will monitor changes in body weight and track safety through regular assessments. Eligible participants are adults 18 to 75 with a BMI meeting criteria and no major health conditions that could confound results. The trial is conducted at two Chinese centers under a lead sponsor and does not list additional collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Recruiting
• Nanjing Drum Tower hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Danli Zhang, M.M
• Email: danli.zhang@hengrui.com
• Phone: 13162215826

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single-dose PK study of HRS-4729 in adults with and without kidney impairment

  This study tests a single dose of HRS-4729 to see how the body handles it in adults with various levels of kidney function compared with healthy adults.

  Recruiting Phase 1 Fujian Shengdi Pharmaceutical Co., Ltd. · Chengdu, Sichuan · NCT07807059

• HRS-4139 safety and pharmacology in healthy adults

  This early-phase study tests a single dose of HRS-4139 to see if it is safe and how the body handles it in healthy adults aged 18–55.

  Recruiting Phase 1 Fujian Shengdi Pharmaceutical Co., Ltd. · Changsha, Hunan · NCT07802964

• HRS-7249 extension study for people with high triglycerides

  This extension study tests whether repeat injections of HRS-7249 are safe and keep triglyceride levels low in adults who previously completed the parent study or have high fasting triglycerides.

  Recruiting at 2 sites Phase 2 Fujian Shengdi Pharmaceutical Co., Ltd. · Jinan, Shandong and 1 other locations · NCT07799688

• HRS5580 plus palonosetron to prevent postoperative nausea and vomiting

  This study tests whether HRS5580 given with palonosetron can prevent nausea and vomiting after surgery in adults undergoing certain procedures.

  Recruiting at 2 sites Phase 2 Fujian Shengdi Pharmaceutical Co., Ltd. · Shanghai, Shanghai Municipality and 1 other locations · NCT07709897

• HRS-4729 and HRS9531 injections in adults with MASH

  This study tests whether HRS-4729 and HRS9531 injections (and their placebos) can help adults with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.

  Recruiting at 2 sites Phase 2 Fujian Shengdi Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality and 1 other locations · NCT07660848

• HRS-5635 in people with chronic hepatitis B who are suppressed on nucleos(t)ide analogues

  A Phase 3 study tests whether HRS-5635 injections cause better viral suppression and safety than placebo in people with chronic hepatitis B who already have low HBV DNA and are on stable NA therapy.

  Recruiting Phase 3 Fujian Shengdi Pharmaceutical Co., Ltd. · Guangzhou, Guangzhou · NCT07606950

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.