A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Management of Body Weight
• Intervention / Treatment: Drug: HRS9531 Tablet; Drug: HRS9531 Tablet Placebo

• Study Type: Interventional
• Enrollment (Estimated): 425
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Qiannan Zhou, M.M; Phone Number: +86-0518-82342973; Email: qiannan.zhou@hengrui.com

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
      • Contact: Huijuan Yuan; Phone Number: +86-0371-65580371; Email: hjyuan@zzu.edu.cn
      • Principal Investigator: Huijuan Yuan
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital
      • Principal Investigator: Yan Bi
      • Contact: Yan Bi; Phone Number: +86-025-83106666; Email: biyan@nju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS9531 Tablet Group; HRS9531 tablet.	Drug: HRS9531 Tablet; HRS9531 tablet.
Placebo Comparator: HRS9531 Tablet Placebo Group; HRS9531 tablet placebo.	Drug: HRS9531 Tablet Placebo; HRS9531 tablet placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change from baseline in body weight after 52 weeks of treatment	After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment	After 52 weeks of treatment.

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment	After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment	After 52 weeks of treatment.
Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment	After 52 weeks of treatment.
Change from baseline in waist circumference after 52 weeks of treatment	After 52 weeks of treatment.
Change from baseline in body weight after 52 weeks of treatment	After 52 weeks of treatment.
Change from baseline in BMI (Body Mass Index) after 52 weeks of treatment	After 52 weeks of treatment.
Change from baseline in blood pressure after 52 weeks of treatment	After 52 weeks of treatment.
Change from baseline in fasting plasma glucose after 52 weeks of treatment	After 52 weeks of treatment.
Change from baseline in fasting serum insulin after 52 weeks of treatment	After 52 weeks of treatment.
Change from baseline in glycosylated hemoglobin after 52 weeks of treatment	After 52 weeks of treatment.
Change from baseline in blood lipid after 52 weeks of treatment	After 52 weeks of treatment.
Change from baseline in blood uric acid after 52 weeks of treatment	After 52 weeks of treatment.
Number of treatment serious adverse events (SAEs) within 57 weeks	Within 57 weeks.
Number of treatment adverse events (AEs) within 57 weeks	Within 57 weeks.

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 22, 2026
• First Submitted That Met QC Criteria: June 22, 2026
• First Posted (Actual): June 26, 2026

Study Record Updates

• Last Update Posted (Actual): June 26, 2026
• Last Update Submitted That Met QC Criteria: June 22, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HRS9531-T-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No