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This is a multicenter, randomized, double-blind, placebo-controlled phase III validation clinical study in Chinese adult non-diabetic overweight or obese Participants. The main purpose is to evaluate the clinical efficacy of BGM0504 injection for 36 weeks of administration as an adjunct to diet, exercise, and behavioral interventions in overweight or obese non-diabetic adults in China for weight management, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg BGM0504 injection | Experimental |
| |
| 10 mg BGM0504 injection | Experimental |
| |
| 15 mg BGM0504 injection | Experimental |
| |
| BGM0504 placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5 mg BGM0504 injection | Drug | 5mg BGM0504 injection administered subcutaneously (SC) once a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Change from baseline in body weight after 36 weeks of treatment | Baseline,Week 36 |
| Percentage of Participants Who Achieve≥5% Body Weight Reduction | Percentage of Participants Who Achieve≥5% Body Weight Reduction | Baseline,Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Body Weight | Percent Change from Baseline in Body Weight after 52weeks of treatment | Baseline, Week 52 |
| Change From Baseline in Body Weight | Change from baseline in body weight |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji,MD, chief physician, Peking University People's Hospital | Contact | 13910978815 | jiln@bjmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| 10 mg BGM0504 injection administered subcutaneously (SC) once a week | Drug | 10mg BGM0504 injection administered subcutaneously (SC) once a week. |
|
| 15 mg BGM0504 injection | Drug | 15mg BGM0504 injection administered subcutaneously (SC) once a week. |
|
| BGM0504 placebo | Drug | BGM0504 placebo administered SC once a week. |
|
| Baseline, Week36 and 52 |
| Percentage of Participants Who Achieve≥5% Body Weight Reduction | Percentage of Participants Who Achieve≥5% Body Weight Reduction | Baseline, Week 36 and 52 |
| Percentage of Participants Who Achieve≥10% Body Weight Reduction | Percentage of Participants Who Achieve≥10% Body Weight Reduction | Baseline, Week 36 and 52 |
| Percentage of Participants Who Achieve≥15%Body Weight Reduction | Percentage of Participants Who Achieve≥15%Body Weight Reduction | Baseline, Week 36 and 52 |
| Percentage of Participants Who Achieve≥20% Body Weight Reduction | Percentage of Participants Who Achieve≥20% Body Weight Reduction. | Baseline, Week 36 and 52 |
| Change From Baseline in Waist Circumference | Change From Baseline in Waist Circumference after 52weeks of treatment. | Baseline, Week 36 and 52 |
| Change From Baseline in Body Mass Index (BMI) | Change From Baseline in Body Mass Index (BMI) after 52weeks of treatment | Baseline, Week 36 and 52 |
| Change From Baseline in Fasting Glucose | Change From Baseline in Fasting Glucose after 52weeks of treatment | Baseline, Week 36 and 52 |
| Change From Baseline in Hemoglobin A1c (HbA1c) | Change From Baseline in Hemoglobin A1c (HbA1c) after 52weeks of treatment. | Baseline, Week 36 and 52 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |