Overweight and Obesity
Conditions
Brief summary
The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in Chinese Obese Subjects.
Interventions
DRUGHRS-7535;Placebo
HRS-7535;Placebo
DRUGPlacebo
Placebo
Sponsors
Shandong Suncadia Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects, 18-65 years of age at the time of signing informed consent; 2. At screening and random visit, 28.0 ≤BMI≤ 40.0 kg/m2; 3. Diet and exercise control for at least 3 months before screening and random visit, and less than 5 % self-reported change 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 hypertension; 3. PHQ-9 score ≥15; 4. History of diabetes; 5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening; 6. 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; 7. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness; 8. Use of any medication or treatment that may have caused significant weight change within 2 months; 9. History of bariatric surgery; 10. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 11. Surgery is planned during the trial; 12. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method; 13. 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 |
|---|---|
| Percent change in body weight from baseline at Week 26 | Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in fasting plasma glucoseat Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in fasting serum insulin at Week 26 and Week 36 | Week 26 and Week 36 |
| Proportion of subjects with weight loss of ≥5%, ≥10%, ≥15% from baseline in body weight at Week 26 and Week 36 | Week 26 and Week 36 |
| Percent change in body weight from baseline at Week 36 | Week 36 |
| Change from baseline in body weight/ waist circumference/ BMI at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in Systolic blood pressure and diastolic blood pressure at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in total cholesterol (TC) at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in low density lipoprotein cholesterol (LDL-C) at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in high Density lipoprotein cholesterol (HDL-C) at Week 26 and Week 3 | Week 26 and Week 3 |
| Change from baseline in triglycerides (TG) at Week 26 and Week 36 | Week 26 and Week 36 |
| Change from baseline in HbA1c at Week 26 and Week 36 | Week 26 and Week 36 |
Countries
China
Outcome results
None listed