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A Phase 3 Trial to Evaluate the Safety and Efficacy of HDM1002 Tablets in Overweight and Obese Adults
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM1002 tablets 200mg once daily | Experimental | HDM1002 200mg, oral, once daily, 52weeks |
|
| HDM1002 tablets 400mg once daily | Experimental | HDM1002 400mg, oral, once daily, 52weeks |
|
| Placebo | Placebo Comparator | HDM1002 placebo, oral, once daily, 52weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM1002 200mg, oral, once daily, 52 weeks | Drug | HDM1002 200mg, oral, once daily, 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change From Baseline in Body Weight | Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg, | 44weeks |
| Percentage Change of Participants Achieving Weight Loss ≥ 5% | Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg | 44weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change of Participants Achieving Weight Loss ≥ 10% and ≥ 15% | Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg. | 44weeks |
| Change From Baseline in Waist Circumference |
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Inclusion Criteria:
BMI≥28 but < 40.0 kg/m2 at screening or randomization,or BMI≥24.0 kg/m2 but < 28 kg/m2 with any of the following:
At least one previous failure to lose weight through lifestyle modification was defined as < 5% weight loss after ≥3 months of lifestyle modification
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Liu Jing Liu | Contact | +8657189903388 | cxyliujing@eastchinapharm.com | |
| Wenwen Tu | Contact | +86-0571-89903388 | tuwenwen@eastchinapharm.com |
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| HDM1002 400mg, oral, once daily, 52 weeks | Drug | HDM1002 400mg, oral, once daily, 52 weeks |
|
| HDM1002 placebo, oral, once daily, 52 weeks | Drug | HDM1002 placebo, oral, once daily, 52 weeks |
|
Waist Circumference was recorded in cm
| 44 weeks, 52 weeks |
| Percentage Change of Participants Achieving Weight Loss ≥ 5% , ≥ 10% and ≥ 15% | Weight was recorded in kilograms (kg), and accuracy to the nearest 0.1 kg. | 52 weeks |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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