Evaluating HRS9531 tablet for weight loss in obese individuals

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 clinical trial aims to assess the efficacy and safety of the HRS9531 tablet in reducing body weight in obese subjects over a 26-week period. Participants will be randomly assigned to receive either the HRS9531 tablet or a placebo, with the primary outcome being the change in body weight. Eligible participants must have a BMI between 28.0 and 40.0 kg/m2 and have maintained a stable weight for at least three months prior to the study. The trial will also monitor any adverse effects associated with the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able and willing to provide a written informed consent;
2. Male or female subjects, 18-65 years of age at the time of signing informed consent;
3. At screening visit, 28.0 ≤BMI≤ 40.0 kg/m2;
4. 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;
5. Non-pregnant or lactating women. Fertile male and female (including partners) agree to use highly effective contraceptive methods.

Exclusion Criteria:

1. Uncontrollable hypertension;
2. 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;
3. PHQ-9 score ≥15;
4. Medical history or illness that affects body weight;
5. History of diabetes;
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years;
9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
10. History of alcohol and/or substance abuse or drug abuse;
11. Use of any medication or treatment that may have caused significant weight change within 3 months;
12. History of bariatric surgery;
13. Known or suspected hypersensitivity to trial product(s) or related products;
14. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
15. Surgery is planned during the trial;
16. Mentally incapacitated or speech-impaired;
17. Acute or chronic hepatitis;
18. The investigators determined that other conditions were inappropriate for participation in this clinical trial.

Where it's running

• Nanjing Drum Tower hospital
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Qiannan Zhou
• Email: qiannan.zhou@hengrui.com
• Phone: 13925049866

Similar studies

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

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

  This study tests whether HRS9531 tablets help people who are overweight or obese lose weight over a year, compared with a placebo.

  Recruiting at 2 sites Phase 3 Fujian Shengdi Pharmaceutical Co., Ltd. · Zhengzhou, Henan and 1 other locations · NCT07670884

• 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

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.