Overweight or Obesity
Conditions
Brief 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.
Interventions
HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks
Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
A multicenter, randomized, double-blind, placebo- parallel controlled Phase II clinical study
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change in body weight | Week 0, Week 24 | Percentage Change from baseline in body weight after 24 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in total cholesterol after 24 weeks of treatment | Week 0, Week 24 |
| Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment | Week 0, Week 24 |
| Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment | Week 0, Week 24 |
| Number of AEs During the Trial | Week 0 to Week 56 |
| Percentage change in body weight | Week 0, Week 32 |
| Change from baseline in waist circumference after 24 weeks of treatment | Week 0, Week 24 |
| Change from baseline in BMI after 24 weeks of treatment | Week 0, Week 24 |
| Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment | Week 24 |
| Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment | Week 24 |
| Change from baseline in blood pressure after 24 weeks of treatment | Week 0, Week 24 |
| Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment | Week 32 |
| Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment | Week 32 |
| Change from baseline in body weight after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in waist circumference after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in BMI after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in blood pressure after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in total cholesterol after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in body weight after 24 weeks of treatment | Week 0, Week 24 |
Countries
China
Outcome results
None listed