Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects

Overweight or Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06054698
• Other study ID #: HRS9531-203
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: October 2023
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Fujian Shengdi Pharmaceutical Co., Ltd.
• Contact: Hongcheng Hu
• Phone: 13672085298
• Email: hongcheng.hu[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 2024
• Est. primary completion date: August 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. 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.

Related Conditions & MeSH terms

• Overweight
• Overweight or Obesity

Intervention

Drug:
• HRS9531 injection
HRS9531 injection , QW,36 weeks
• HRS9531 injection Placebo
HRS9531 injection Placebo,QW,36 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Shengdi Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in body weight		Week 0, Week 36
Secondary	Proportion of Subjects with weight loss of =5% from baseline in body weight after 36 weeks of treatment		Week 36
Secondary	Proportion of Subjects with weight loss of =10% from baseline in body weight after 36 weeks of treatment		Week 36
Secondary	Proportion of Subjects with weight loss of =15% from baseline in body weight after 36 weeks of treatment		Week 36
Secondary	Change from baseline in body weight after 36 weeks of treatment		Week 0, Week 36
Secondary	Change from baseline in waist circumference after 36 weeks of treatment		Week 0, Week 36
Secondary	Change from baseline in BMI after 36 weeks of treatment		Week 0, Week 36
Secondary	Change from baseline in blood pressure after 36 weeks of treatment		Week 0, Week 36
Secondary	Change from baseline in total cholesterol after 36 weeks of treatment		Week 0, Week 36
Secondary	Change from baseline in fasting plasma glucose (FPG) after 36 weeks of treatment		Week 0, Week36
Secondary	Change from baseline in glycosylated haemoglobin (HbA1c) after 36 weeks of treatment		Week 0, Week 36
Secondary	Number of AEs During the Trial		Week 0 to Week 36