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

Phase 3

Recruiting

• Conditions: Overweight or Obesity
• Interventions: Drug: HRS9531 injection; Drug: Placebo

• Registration Number: NCT06396429
• Lead Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Status Verified: 2024-05
• Study First Posted: 2024-05-02
• Study Start: 2024-05-13
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30
• Primary Completion: 2025-07-30
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 540

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A: HRS9531 injection	HRS9531 injection	-
Treatment group B: HRS9531 injection	HRS9531 injection	-
Treatment group C: HRS9531 injection	HRS9531 injection	-
Placebo injection	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change from baseline in BMI 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 in scores of SF-36 V2 from baseline after 48 weeks of treatment	Baseline, Week 48
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 Total Cholesterol 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 waist circumference 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 Low Density Lipoprotein (LDL) 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
Number of AEs during the trial	week 0 to week 52

Trial Locations

Locations (1)

Zhongshan Hospital Affiliated to Fudan University; 🇨🇳 Shanghai, Shanghai, China