Efficacy and Safety of HRS9531 Tablet in Obese Subjects

Phase 2

Recruiting

• Conditions: Chronic Management of Body Weight
• Interventions: Drug: HRS9531 Tablet; Drug: HRS9531 Tablet placebo

• Registration Number: NCT06841445
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief Summary

To evaluate the efficacy of HRS9531 tablet compared with placebo in reducing body weight in obese subjects after 26 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-18
• Study First Submitted QC: 2025-02-18
• Study First Posted: 2025-02-24
• Status Verified: 2025-04
• Study Start: 2025-04-07
• Last Update Submitted: 2025-04-23
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-11
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A: HRS9531 Tablet	HRS9531 Tablet	-
Treatment group B: HRS9531 Tablet	HRS9531 Tablet	-
Treatment group C: HRS9531 Tablet	HRS9531 Tablet	-
Treatment group D: HRS9531 Tablet Placebo	HRS9531 Tablet placebo	-

Primary Outcome Measures

Name	Time	Method
Percentage Change from baseline in body weight after 26 weeks of treatment	after 26 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with weight loss of ≥5% from baseline in body weight after 26 weeks of treatment	after 26 weeks of treatment
Proportion of subjects with weight loss of ≥10% from baseline in body weight after 26 weeks of treatment	after 26 weeks of treatment
Proportion of subjects with weight loss of ≥15% from baseline in body weight after 26 weeks of treatment	after 26 weeks of treatment
Change from baseline in body weight after 26 weeks of treatment	after 26 weeks of treatment
Change from baseline in waist circumference after 26 weeks of treatment	after 26 weeks of treatment
Change from baseline in BMI after 26 weeks of treatment	after 26 weeks of treatment
Change from baseline in blood pressure after 26 weeks of treatment	after 26 weeks of treatment
Change from baseline in blood lipid after 26 weeks of treatment	after 26 weeks of treatment
Change from baseline in blood uric acid after 26 weeks of treatment	after 26 weeks of treatment

Trial Locations

Locations (1)

Nanjing Drum Tower hospital; 🇨🇳 Nanjing, Jiangsu, China