Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Overweight or Obesity Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo- Parallel Controlled, Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05881837
• Other study ID #: HRS9531-201
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 13, 2023
• Est. completion date: October 8, 2024

Study information

• Verified date: August 2023
• Source: Fujian Shengdi Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 249
• Est. completion date: October 8, 2024
• Est. primary completion date: October 8, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 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. 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 and in-situ cancer of the cervix;

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 within 1 year prior to screening;

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. Participation in other clinical trials for any weight-loss indication within 3 months prior to screening, or participation in other clinical trials for any drug or medical device within 1 month prior to screening;

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. Mentally incapacitated or speech-impaired;

18. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;

19. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity

Intervention

Drug:
• HRS9531 injection
HRS9531 injection: dose level 1 for 32 weeks?level 2 for 20 weeks
• HRS9531 injection
HRS9531 injection: dose level 2
• HRS9531 injection
HRS9531 injection: dose level 3
• HRS9531 injection
HRS9531 injection: dose level 4
• HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks?HRS9531 injection level 2 for 20 weeks
• HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks?HRS9531 injection level 2 for 20 weeks
• HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks?HRS9531 injection level 2 for 20 weeks
• HRS9531 injection Placebo
Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks?HRS9531 injection level 2 for 20 weeks

Locations

Country	Name	City	State
China	Zhongshan Hospital Affiliated to Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Shengdi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in body weight	Percentage Change from baseline in body weight after 24 weeks of treatment	Week 0, Week 24
Secondary	Proportion of subjects with weight loss of =5% from baseline in body weight after 24 weeks of treatment		Week 24
Secondary	Proportion of subjects with weight loss of =10% from baseline in body weight after 24 weeks of treatment		Week 24
Secondary	Change from baseline in body weight after 24 weeks of treatment		Week 0, Week 24
Secondary	Change from baseline in waist circumference after 24 weeks of treatment		Week 0, Week 24
Secondary	Change from baseline in BMI after 24 weeks of treatment		Week 0, Week 24
Secondary	Change from baseline in blood pressure after 24 weeks of treatment		Week 0, Week 24
Secondary	Change from baseline in total cholesterol after 24 weeks of treatment		Week 0, Week 24
Secondary	Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment		Week 0, Week 24
Secondary	Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment		Week 0, Week 24
Secondary	Number of AEs During the Trial		Week 0 to Week 56
Secondary	Percentage change in body weight		Week 0, Week 32
Secondary	Proportion of Subjects with weight loss of =5% from baseline in body weight after 32 weeks of treatment		Week 32
Secondary	Proportion of Subjects with weight loss of =10% from baseline in body weight after 32 weeks of treatment		Week 32
Secondary	Change from baseline in body weight after 32 weeks of treatment		Week 0, Week 32
Secondary	Change from baseline in waist circumference after 32 weeks of treatment		Week 0, Week 32
Secondary	Change from baseline in BMI after 32 weeks of treatment		Week 0, Week 32
Secondary	Change from baseline in blood pressure after 32 weeks of treatment		Week 0, Week 32
Secondary	Change from baseline in total cholesterol after 32 weeks of treatment		Week 0, Week 32
Secondary	Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment		Week 0, Week 32
Secondary	Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment		Week 0, Week 32