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To assess the efficacy and safety of THDBH120 injection compared with placebo in weight reduction in overweight or obese subjects after 26 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THDBH120 injection | Experimental |
| |
| Placebo of THDBH120 injection | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THDBH120 injection | Drug | Participants received THDBH120 by subcutaneous injection. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in body weight | Baseline, Week26 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve ≥5% Body Weight Reduction | Baseline, Week26 | |
| Percentage of Participants Who Achieve ≥10% Body Weight Reduction | Baseline, Week26 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Xiangya Hospital of Central South University | Recruiting | 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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| Placebo of THDBH120 injection |
| Drug |
Participants received placebo by subcutaneous injection. |
|
| Percentage of Participants Who Achieve ≥15% Body Weight Reduction |
| Baseline, Week26 |
| Percentage of Participants Who Achieve ≥20% Body Weight Reduction | Baseline, Week26 |
| Change from baseline in waist circumference after the treatment | Baseline, Week 26 |
| Change from baseline in BMI after the treatment | Baseline, Week 26 |
| Change from baseline in blood pressure after the treatment | Baseline, Week 26 |
| Change from baseline in HbA1c after the treatment | Baseline, Week 26 |
| Change from baseline in total cholesterol after the treatment | Baseline, Week 26 |
| Number of Participants with One or More Adverse Event(s) and Serious Adverse Event(s) | Week 30 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |