To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese

Efficacy and Safety of HRS9531 in Overweight or Obese Participants: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial

The study aims to evaluate the efficacy and safety of HRS9531 in subjects with overweight or obese for 48 weeks.

Study Overview

• Status: Completed
• Conditions: Overweight or Obesity
• Intervention / Treatment: Drug: HRS9531 injection; Drug: HRS9531 injection; Drug: HRS9531 injection; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 567
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital Affiliated to Fudan University

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 years of age at the time of signing informed consent.
3. At screening visit, BMI≥28.0 Kg/m2, or ≥24 Kg/m2 with at least one weight-related complication, such as prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, and nonalcoholic fatty liver disease.
4. Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
5. Fertile male and female subjects (including partners) have no plans to have children and agree to use effective contraception within 2 months after signing the informed consent form and the last medication, and fertile female or male subjects have no plans to donate eggs/sperm; Fertile female subjects tested negative for regnancy within the first 3 days of randomization and were not lactating.

Exclusion Criteria:

1. Presence of clinically significant lab results at screening visit;
2. Uncontrollable hypertension;
3. PHQ-9 score ≥15;
4. Medical history or illness that affects your weight;
5. History of diabetes;
6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening;
7. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
8. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin、 in-situ cancer of the cervix and in-situ cancer of the prostate;
9. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
10. Known or suspected history of alcohol and/or substance abuse or drug abuse;
11. History of acute or chronic hepatitis or other serious liver disease other than alcoholic fatty liver disease.
12. Have received or plan to have an organ or bone marrow transplant during the study.
13. The presence of any blood disorders that may interfere with HbA1c testing.
14. Autoimmune disease is present and systemic glucocorticoid therapy or immunosuppressive therapy is planned during the study.
15. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
16. Weight loss surgery or endoscopic and/or medical device-based weight loss therapy is planned for or during the study period;
17. Use of drugs or treatments that may have caused significant weight gain or loss within the 3 months prior to screening;
18. Patients with blood donation or blood loss ≥400 mL or receiving blood transfusion within 3 months before screening.
19. Surgery is planned during the tria;
20. Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process；
21. In the investigator's judgment, there are circumstances (medical, psychological, social, or geographical factors, etc.) that affect subject safety or any other conditions that interfere with the evaluation of the test results.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo injection	Drug: Placebo; blank preparation, participants received matching placebo.
Experimental: Treatment group A: HRS9531 injection	Drug: HRS9531 injection; HRS9531 injection; low dose; Drug: HRS9531 injection; HRS9531 injection; medium dose; Drug: HRS9531 injection; HRS9531 injection, high dose
Experimental: Treatment group B: HRS9531 injection	Drug: HRS9531 injection; HRS9531 injection; low dose; Drug: HRS9531 injection; HRS9531 injection; medium dose; Drug: HRS9531 injection; HRS9531 injection, high dose
Experimental: Treatment group C: HRS9531 injection	Drug: HRS9531 injection; HRS9531 injection; low dose; Drug: HRS9531 injection; HRS9531 injection; medium dose; Drug: HRS9531 injection; HRS9531 injection, high dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change from baseline in weight after 48 weeks of treatment	Baseline, Week 48
Proportion of subjects with weight loss of≥5% from baseline after 48 weeks of treatment	Week 48

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects with weight loss of ≥10% from baseline after 48 weeks of treatment	Week 48
Proportion of subjects with weight loss of ≥15% from baseline after 48 weeks of treatment	Week 48
Change from baseline in waist circumference after 48 weeks of treatment	Baseline, Week 48
Change from baseline in weight after 48 weeks of treatment	Baseline, Week 48
Change from baseline in BMI after 48 weeks of treatment	Baseline, Week 48
Change from baseline in systolic blood pressure after 48 weeks of treatment	Baseline, Week 48
Change from baseline in diastolic blood pressure after 48 weeks of treatment	Baseline, Week 48
Change from baseline in Total Cholesterol after 48 weeks of treatment	Baseline, Week 48
Change from baseline in Low Density Lipoprotein (LDL) Cholesterol after 48 weeks of treatment	Baseline, Week 48
Change from baseline in Triglycerides after 48 weeks of treatment	Baseline, Week 48
Change from baseline in High Density Lipoprotein (HDL) Cholesterol after 48 weeks of treatment	Baseline, Week 48
Change from baseline in fasting plasma glucose (FPG) after 48 weeks of treatment	Baseline, Week 48
Change from baseline in glycosylated haemoglobin (HbA1c) after 48 weeks of treatment	Baseline, Week 48
Change from baseline in fasting serum insulin after 48 weeks of treatment	Baseline, Week 48
Change in scores of SF-36 V2 from baseline after 48 weeks of treatment	Baseline, Week 48
Number of AEs during the trial	week 0 to week 52

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2024
• Primary Completion (Actual): July 7, 2025
• Study Completion (Actual): July 7, 2025

Study Registration Dates

• First Submitted: April 30, 2024
• First Submitted That Met QC Criteria: April 30, 2024
• First Posted (Actual): May 2, 2024

Study Record Updates

• Last Update Posted (Actual): July 11, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight
• Other Study ID Numbers: HRS9531-301

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