Chronic Management of Body Weight
Conditions
Brief summary
This study aims to evaluate the efficacy and safety of HRS9531 tablets compared with placebo in reducing body weight in overweight or obese subjects after 52 weeks of treatment.
Interventions
DRUGHRS9531 Tablet
HRS9531 tablet.
HRS9531 tablet placebo.
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HRS9531 tablets compared with placebo.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects, 18-75 years of age at the time of signing informed consent; 2. At screening visit, BMI ≥ 28 kg/m2 or ≥ 24 kg/m2 with at least one weight-related comorbidity; 3. 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; 4. Able and willing to provide a written informed consent.
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 severe hypertension; 3. PHQ-9 score ≥ 15; 4. Medical history or illness that affects body weight; 5. History of diabetes; 6. Acute or chronic hepatitis; 7. History of severe cardiovascular and cerebrovascular diseases within 6 months prior to screening; 8. Any organ-system malignancies developed within 5 years; 9. Acute infection, acute trauma, or medium to large surgery within 30 days prior to screening; 10. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness, mentally incapacitated or speech-impaired; 11. Use of any medication or treatment that may have caused significant weight change within 90 days; 12. History of bariatric surgery; 13. Known or suspected hypersensitivity to trial product(s) or related products; 14. History of alcohol and/or substance abuse or drug abuse; 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. The investigators determined that other conditions were inappropriate for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with weight loss of ≥ 5% from baseline in body weight after 52 weeks of treatment | After 52 weeks of treatment. |
| Percentage change from baseline in body weight after 52 weeks of treatment | After 52 weeks of treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in blood uric acid after 52 weeks of treatment | After 52 weeks of treatment. |
| Number of treatment serious adverse events (SAEs) within 57 weeks | Within 57 weeks. |
| Number of treatment adverse events (AEs) within 57 weeks | Within 57 weeks. |
| Change from baseline in BMI (Body Mass Index) after 52 weeks of treatment | After 52 weeks of treatment. |
| Change from baseline in blood pressure after 52 weeks of treatment | After 52 weeks of treatment. |
| Change from baseline in fasting plasma glucose after 52 weeks of treatment | After 52 weeks of treatment. |
| Change from baseline in fasting serum insulin after 52 weeks of treatment | After 52 weeks of treatment. |
| Proportion of subjects with weight loss of ≥ 10% from baseline in body weight after 52 weeks of treatment | After 52 weeks of treatment. |
| Proportion of subjects with weight loss of ≥ 15% from baseline in body weight after 52 weeks of treatment | After 52 weeks of treatment. |
| Proportion of subjects with weight loss of ≥ 20% from baseline in body weight after 52 weeks of treatment | After 52 weeks of treatment. |
| Change from baseline in waist circumference after 52 weeks of treatment | After 52 weeks of treatment. |
| Change from baseline in glycosylated hemoglobin after 52 weeks of treatment | After 52 weeks of treatment. |
| Change from baseline in body weight after 52 weeks of treatment | After 52 weeks of treatment. |
| Change from baseline in blood lipid after 52 weeks of treatment | After 52 weeks of treatment. |
Countries
China
Contacts
CONTACTDanli Zhang, M.M
Outcome results
None listed