Efficacy and Safety of HRS9531 Tablet in Obese Subjects

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Management of Body Weight
• Intervention / Treatment: Drug: HRS9531 Tablet; Drug: HRS9531 Tablet; Drug: HRS9531 Tablet; Drug: HRS9531 Tablet placebo

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group A: HRS9531 Tablet	Drug: HRS9531 Tablet; HRS9531 Tablet dose 1; Drug: HRS9531 Tablet; HRS9531 Tablet dose 2; Drug: HRS9531 Tablet; HRS9531 Tablet dose 3
Experimental: Treatment group B: HRS9531 Tablet	Drug: HRS9531 Tablet; HRS9531 Tablet dose 1; Drug: HRS9531 Tablet; HRS9531 Tablet dose 2; Drug: HRS9531 Tablet; HRS9531 Tablet dose 3
Experimental: Treatment group C: HRS9531 Tablet	Drug: HRS9531 Tablet; HRS9531 Tablet dose 1; Drug: HRS9531 Tablet; HRS9531 Tablet dose 2; Drug: HRS9531 Tablet; HRS9531 Tablet dose 3
Placebo Comparator: Treatment group D: 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 26 weeks of treatment	after 26 weeks of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Actual): January 8, 2026
• Study Completion (Actual): January 8, 2026

Study Registration Dates

• First Submitted: February 18, 2025
• First Submitted That Met QC Criteria: February 18, 2025
• First Posted (Actual): February 24, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: March 30, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight
• Other Study ID Numbers: HRS9531-T-201

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