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The main purpose of this study is to assess the Efficacy and safety of HS-20094 in overweight and obese patients. The study will last up to approximately 52 weeks.
This is a phase Ⅲ, double-blind, randomised, placebo-controlled trial to assess the efficacy of HS-20094 in Chinese subjects with overweight or obesity. We enrolled adults (aged 18-65 years, both inclusive) with overweight (body-mass index [BMI] ≥24 kg/m2) accompanied by at least one obesity-related comorbidity or obesity (BMI ≥28 kg/m2) in China. Eligible participants were randomly assigned to receive once-weekly subcutaneous HS-20094 or placebo for 48 weeks. The co-primary endpoints were the percent change in bodyweight from baseline and the proportion of patients achieving weight loss≥5% from baseline after 48 weeks treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HS-20094 5mg | Experimental |
| |
| HS-20094 10mg | Experimental |
| |
| HS-20094 15mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HS-20094 injection | Drug | Administered SC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Percent Change from Baseline in Body Weight | Baseline, week 48 |
| Percentage of Participants Who Achieve weight loss≥ 5% from Baseline | Percentage of Participants Who Achieve weight loss≥ 5% from Baseline | Baseline, week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline | Percentage of Participants Who Achieve weight loss≥10% and 15% from Baseline | Baseline, week 4 |
| Change in waist circumference from baseline at week 48 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 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 injection | Drug | Administered SC |
|
Change in waist circumference from baseline at week 48
| Baseline, week 48 |
| Percentage change in body weight from baseline at week 24 | Percentage change in body weight from baseline at week 24 | Baseline, week 24 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |