Evaluating HRS9531 tablet for weight loss in obese individuals

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Tablet in Obese Subjects

This study is testing if the HRS9531 tablet can help people who are obese lose weight safely over six months.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06841445 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are obese adults aged 18-65 with a stable weight and a BMI between 28.0 and 40.0 kg/m2.

Not a fit: Patients with uncontrolled hypertension, significant cardiovascular issues, or a history of diabetes may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective new option for weight management in obese patients.

How similar studies have performed: While there have been various studies on weight loss medications, the specific approach of HRS9531 is novel and has not been extensively tested in prior trials.

Eligibility criteria

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 this trial is running

Nanjing, Jiangsu

• Nanjing Drum Tower hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Qiannan Zhou

Conditions Chronic Management of Body Weight