Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects

A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Overweight or Obese Subjects

To assess the efficacy of HRS9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 weeks of treatment.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 221000
      • The Affiliated Hospital of Xuzhou Medicine University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310007
      • Zhejiang Hospital
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

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. 28.0 ≤BMI≤ 40.0 kg/m2 or 24 ≤BMI< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit.
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.

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. poor-controlled hypertension.
3. PHQ-9 score ≥15.
4. Medical history of illness that affects 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.
8. Any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ.
9. Confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness.
10. History of alcohol , medication or drug abuse within 1 year prior to screening.
11. Use of any medication or treatment that may cause significant weight change within 3 months.
12. History of bariatric surgery.
13. Subjects participating in QT/QTc studies need to comply with relevant examinations.
14. Known or suspected hypersensitivity to trial product(s) or related products.
15. Participation in other clinical trials within 3 month prior to screening.
16. History of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening
17. Surgery is planned during the trial.
18. Mentally incapacitated or speech-impaired.
19. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method.
20. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.
21. In the judgment of the investigator, there are circumstances that affect the safety of the subject or any other interference 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HRS9531 injection	Drug: HRS9531 injection; HRS9531 injection , QW，36 weeks
Placebo Comparator: HRS9531 injection Placebo	Drug: HRS9531 injection Placebo; HRS9531 injection Placebo，QW，36 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in body weight	Week 0, Week 36

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of AEs During the Trial	Week 0 to Week 36
Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 36 weeks of treatment	Week 36
Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 36 weeks of treatment	Week 36
Proportion of Subjects with weight loss of ≥15% from baseline in body weight after 36 weeks of treatment	Week 36
Change from baseline in body weight after 36 weeks of treatment	Week 0, Week 36
Change from baseline in waist circumference after 36 weeks of treatment	Week 0, Week 36
Change from baseline in BMI after 36 weeks of treatment	Week 0, Week 36
Change from baseline in blood pressure after 36 weeks of treatment	Week 0, Week 36
Change from baseline in total cholesterol after 36 weeks of treatment	Week 0, Week 36
Change from baseline in fasting plasma glucose (FPG) after 36 weeks of treatment	Week 0, Week36
Change from baseline in glycosylated haemoglobin (HbA1c) after 36 weeks of treatment	Week 0, Week 36

Collaborators and Investigators

• Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2023
• Primary Completion (Actual): September 9, 2024
• Study Completion (Actual): September 9, 2024

Study Registration Dates

• First Submitted: September 19, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 26, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HRS9531-203

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