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The study is being conducted to assess the efficacy and safety of SHR20004 on body weight in obese subjects without diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Experimental |
| |
| Treatment group C | Experimental |
| |
| Treatment group D | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR20004 | Drug | SHR20004：low dose |
| |
| SHR20004 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in body weight | Change from baseline in body weight in kilograms | Week 0, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in body weight(%) | Relative change from baseline in body weight(%) | Week 0, Week 24 |
| Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China | ||
| Shanxi Provincial People's Hospital |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Parallel Assign to SHR20004 or placebo
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| Drug |
SHR20004: medium dose |
|
| SHR20004 | Drug | SHR20004: high dose |
|
| placebo | Drug | Placebo |
|
Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline
| Week 0, Week 24 |
| Change from baseline in fasting plasma glucose | Change from baseline in fasting plasma glucose in mmol/L | Week 0, Week 24 |
| Change from baseline in fasting insulin | Change from baseline in fasting insulin in μU/ml | Week 0, Week 24 |
| Change from baseline in fasting C-peptide | Change from baseline in fasting C-peptide in ng/ml | Week 0, Week 24 |
| Change from baseline in fasting blood lipids | Change from baseline in fasting blood lipids including TC\TG\H-DLC\L-DLC in mmol/L | Week 0, Week 24 |
| Change from baseline in glycosylated hemoglobin | Change from baseline in glycosylated hemoglobin(%) | Week 0, Week 24 |
| Change from baseline in blood pressure | Change from baseline in blood pressure in mmHg | Week 0, Week 24 |
| Change from baseline in waist circumference | Change from baseline in waist circumference in cm | Week 0, Week 24 |
| Change from baseline in waist-to-hip ratio | Change from baseline waist-to-hip ratio（waist and hip will be combined to report waist-to-hip ratio) | Week 0, Week 24 |
| Change from baseline in BMI | Change from baseline in BMI (weight and height will be combined to report BMI in kg/m^2) | Week 0, Week 24 |
| Change from baseline in plasma glucose of 120 minutes after oral glucose tolerance test （OGTT） | Change from baseline in plasma glucose of 120 minutes after OGTT in mmol/L | Week 0, Week 24 |
| Change from baseline in insulin of 120 minutes after oral glucose tolerance test （OGTT） | Change from baseline in insulin of 120 minutes after OGTT in μU/ml | Week 0, Week 24 |
| Change from baseline in C-peptide of 120 minutes after oral glucose tolerance test （OGTT） | Change from baseline in C-peptide of 120 minutes after OGTT in ng/ml | Week 0, Week 24 |
| Change from baseline in AUC0-2h of plasma glucose during OGTT | Change from baseline in AUC0-2h of plasma glucose during OGTT in mmol*hr/L | Week 0, Week 24 |
| Change from baseline in AUC0-2h of insulin during OGTT | Change from baseline in AUC0-2h of insulin during OGTT in μU*hr/ml | Week 0, Week 24 |
| Change from baseline in AUC0-2h of C peptide during OGTT | Change from baseline in AUC0-2h of C peptide during OGTT in ng*hr/ml | Week 0, Week 24 |
| 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 | 12-lead ECG in heart rate（beats）, PR interval（ms）, QT interval(ms), QTC interval(ms), and overall conclusion description | Week 0-25 |
| Concentration of SHR20004 in plasma at steady state | Week 8 |
| Taiyuan |
| Shanxi |
| 030000 |
| China |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |