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To assess the effect of BGM0504 injection versus placebo on weight loss in overweight or obese subjects after 24 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 5 mg BGM0504 | Experimental | 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week. |
|
| 10 mg BGM0504 | Experimental | 10 mg BGM0504 administered SC once a week. |
|
| 15 mg BGM0504 | Experimental | 15 mg BGM0504 administered SC once a week. |
|
| Placebo | Placebo Comparator | Placebo administered SC once a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM0504 | Drug | Administered SC |
| |
| BGM0504 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in body weight | Percentage change from baseline in body weight after 24 weeks of treatment. | Week 0 to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects with weight loss of ≥5% | Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment | Week 0 to Week 24 |
| Change from baseline in waist circumference |
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Inclusion Criteria:
Exclusion Criteria:1.Those who have used weight loss drugs within 12 weeks before screening; 2. Previous diagnosis of type 1 or type 2 diabetes mellitus; 3. History of acute or chronic pancreatitis, or pancreatic injury; 4. History of thyroid C-cell carcinoma, MEN (multiple endocrine adenomatosis) 2A or 2B, or relevant family history; 5. Subjects with uncontrolled hypertension after treatment (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥ 100 mmHg at screening) or untreated blood pressure meeting the above criteria at screening; 6. Concomitant thyroid dysfunction that cannot be controlled at a stable drug dose atscreening, or clinically significant abnormalities in thyroid function test results at screening that require initiation of therapy; 7. At Screening, abdominal ultrasound indicated calculus gallbladder and polyps, or presence of clinical symptoms of gallbladder disease at Screening; 8. Pregnant or breastfeeding women.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | 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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| Drug |
Administered SC |
|
| BGM0504 | Drug | Administered SC |
|
| Placebo | Drug | Administered SC |
|
Change from baseline in waist circumference after 24 weeks of treatment
| Week 0 to Week 24 |
| Change from baseline in BMI | Change from baseline in BMI after 24 weeks of treatment | Week 0 to Week 24 |
| Change from baseline in fasting plasma glucose (FPG) | Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment | Week 0 to Week 24 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |