Chronic Management of Body Weight
Conditions
Brief summary
To evaluate the efficacy of HRS9531 tablet compared with placebo in reducing body weight in obese subjects after 26 weeks of treatment.
Interventions
DRUGHRS9531 Tablet
HRS9531 Tablet dose 1
HRS9531 Tablet placebo
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 the weight change does not exceed 5% within the last 3 months; 5. Non-pregnant or lactating women. Fertile male and female (including partners) agree to use highly effective contraceptive methods.
Exclusion criteria
1. Uncontrollable hypertension; 2. 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; 3. PHQ-9 score ≥15; 4. Medical history or illness that affects body weight; 5. History of diabetes; 6. Acute infection, acute trauma, or medium to large surgery within 1 month prior to screening; 7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening; 8. Any organ-system malignancies developed within 5 years; 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; 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. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 15. Surgery is planned during the trial; 16. Mentally incapacitated or speech-impaired; 17. Acute or chronic hepatitis; 18. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage Change from baseline in body weight after 26 weeks of treatment | after 26 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with weight loss of ≥5% from baseline in body weight after 26 weeks of treatment | after 26 weeks of treatment |
| Proportion of subjects with weight loss of ≥10% from baseline in body weight after 26 weeks of treatment | after 26 weeks of treatment |
| Proportion of subjects with weight loss of ≥15% from baseline in body weight after 26 weeks of treatment | after 26 weeks of treatment |
| Change from baseline in body weight after 26 weeks of treatment | after 26 weeks of treatment |
| Change from baseline in waist circumference after 26 weeks of treatment | after 26 weeks of treatment |
| Change from baseline in BMI after 26 weeks of treatment | after 26 weeks of treatment |
| Change from baseline in blood pressure after 26 weeks of treatment | after 26 weeks of treatment |
| Change from baseline in blood lipid after 26 weeks of treatment | after 26 weeks of treatment |
| Change from baseline in blood uric acid after 26 weeks of treatment | after 26 weeks of treatment |
Countries
China
Outcome results
None listed