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This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study in adult obese/overweight subjects in China to evaluate the efficacy and safety of GZR18 Injection in the subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GZR18 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GZR18 | Drug | Used as specified in the protocol |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change in weight from baseline (%) | From Week 0 to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with ≥ 10%, 15%, 20%, and 25% decrease in weight from baseline | From Week 0 to Week 48 | |
| Changes from baseline in weight | From Week 0 to Week 48 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | Beijing | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Other |
Administered the same volume as GZR18 |
|
| Changes from baseline in body mass index (BMI) |
weight and height will be combined to report BMI in kg/m^2 |
| From Week 0 to Week 48 |
| Changes from baseline in hip circumference | From Week 0 to Week 48 |
| Changes from baseline in waist circumference | From Week 0 to Week 48 |
| Changes from baseline in waist-hip ratio (waist circumference/hip circumference) | From Week 0 to Week 48 |
| Treatment emergent adverse events (TEAEs) | From Week 0 to Week 48 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |