Obesity
Conditions
Brief summary
The study is being conducted to assess the efficacy and safety of SHR20004 on body weight in obese subjects without diabetes.
Interventions
DRUGSHR20004
SHR20004：low dose
DRUGplacebo
Placebo
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Parallel Assign to SHR20004 or placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Informed consent obtained prior to any trial-related activities 2. Body mass index (BMI) between 28 and 40 kg/m2(both inclusive) 3. Diet and exercise management for at least 3 months before screening and less than 5% change in body weight during the previous 3 months（self-reported）.
Exclusion criteria
1. History of endocrine disease or treatment that may significantly affect body weight prior to screening visit 2. History of diabetes 3. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) 4. History of pancreatitis 5. Previous surgical treatment of obesity 6. Screening calcitonin of 20 ng/L or above
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in body weight | Week 0, Week 24 | Change from baseline in body weight in kilograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline | Week 0, Week 24 | Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline |
| Change from baseline in fasting plasma glucose | Week 0, Week 24 | Change from baseline in fasting plasma glucose in mmol/L |
| Change from baseline in fasting insulin | Week 0, Week 24 | Change from baseline in fasting insulin in μU/ml |
| Change from baseline in fasting C-peptide | Week 0, Week 24 | Change from baseline in fasting C-peptide in ng/ml |
| Change from baseline in fasting blood lipids | Week 0, Week 24 | Change from baseline in fasting blood lipids including TC\\TG\\H-DLC\\L-DLC in mmol/L |
| Change from baseline in glycosylated hemoglobin | Week 0, Week 24 | Change from baseline in glycosylated hemoglobin(%) |
| Change from baseline in blood pressure | Week 0, Week 24 | Change from baseline in blood pressure in mmHg |
| Change from baseline in waist circumference | Week 0, Week 24 | Change from baseline in waist circumference in cm |
| Change from baseline in waist-to-hip ratio | Week 0, Week 24 | Change from baseline waist-to-hip ratio（waist and hip will be combined to report waist-to-hip ratio) |
| Change from baseline in BMI | Week 0, Week 24 | Change from baseline in BMI (weight and height will be combined to report BMI in kg/m\^2) |
| Relative change from baseline in body weight(%) | Week 0, Week 24 | Relative change from baseline in body weight(%) |
| Change from baseline in insulin of 120 minutes after oral glucose tolerance test （OGTT） | Week 0, Week 24 | Change from baseline in insulin of 120 minutes after OGTT in μU/ml |
| Change from baseline in C-peptide of 120 minutes after oral glucose tolerance test （OGTT） | Week 0, Week 24 | Change from baseline in C-peptide of 120 minutes after OGTT in ng/ml |
| Change from baseline in AUC0-2h of plasma glucose during OGTT | Week 0, Week 24 | Change from baseline in AUC0-2h of plasma glucose during OGTT in mmol\*hr/L |
| Change from baseline in AUC0-2h of insulin during OGTT | Week 0, Week 24 | Change from baseline in AUC0-2h of insulin during OGTT in μU\*hr/ml |
| Change from baseline in AUC0-2h of C peptide during OGTT | Week 0, Week 24 | Change from baseline in AUC0-2h of C peptide during OGTT in ng\*hr/ml |
| Percentage of subjects developing anti-drug antibody of SHR20004 | Week 0-25 | — |
| Percentage of subjects with an Adverse events | Week 0-25 | — |
| Percentage of subjects with Injection site reactions | Week 0-25 | — |
| 12-lead ECG | Week 0-25 | 12-lead ECG in heart rate（beats）, PR interval（ms）, QT interval(ms), QTC interval(ms), and overall conclusion description |
| Concentration of SHR20004 in plasma at steady state | Week 8 | — |
| Change from baseline in plasma glucose of 120 minutes after oral glucose tolerance test （OGTT） | Week 0, Week 24 | Change from baseline in plasma glucose of 120 minutes after OGTT in mmol/L |
Countries
China
Outcome results
None listed