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This study will evaluate the percentage change in body weight from baseline and proportion of subjects achieving ≥ 5% weight loss from baseline after 52 weeks of treatment with Zovaglutide in subjects with overweight/obesity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zovaglutide dose 1 | Experimental | administered subcutaneously (SC), Q4W |
|
| Zovaglutide dose 2 | Experimental | administered subcutaneously (SC), Q4W |
|
| Placebo | Placebo Comparator | Administered subcutaneously (SC), Q4W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zovaglutide dose 1 | Drug | administered subcutaneously (SC), Q4W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight(%) | baseline (week 0) to week 52 | |
| Proportion of subjects achieving ≥ 5% weight loss | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving ≥10% weight loss | week 52 | |
| Proportion of subjects achieving ≥15% weight loss. | week 52 | |
| Proportion of subjects achieving ≥20% weight loss. |
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Inclusion Criteria:
1. Male or female subjects aged≥18years and≤75 years at the time of signing the ICF.
2.At screening and prior to randomization, BMI must meet one of the following criteria:
3.Weight change due to diet and exercise alone within 3 months prior to screening and randomization did not exceed 5%.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yuanyuan Zhang, PhD | Contact | 13581521105 | yuanyuan@qlbiopharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Linong Ji, MD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuancheng People's Hospital | Xuancheng | Anhui | 242099 | China |
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| Zovaglutide dose 2 | Drug | administered subcutaneously (SC), Q4W |
|
|
| Placebo | Drug | administered subcutaneously (SC), Q4W |
|
| week 52 |
| Change in body weight (kg) | Baseline (week 0) to week 52 |
| Change in BMI (kg/m²) | Baseline (week 0) to week 52 |
| Change in waist circumference (cm) | Baseline (week 0) to week 52 |
| Change in hip circumference (cm) | Baseline (week 0) to week 52 |
| Number of Treatment Emergent Adverse Events (TEAEs) | Baseline (week 0) to week 56 |
| Number of Serious Adverse Events (SAEs) | Baseline (week 0) to week 56 |
| Positive rate of anti-drug antibodies (ADA). | Baseline (week 0) to week 56 |
| Positive rate of neutralizing antibodies (Nab) | Baseline (week 0) to week 56 |
| Gansu Provincial Hospital | Lanzhou | Gansu | 730099 | China |
|
| Guangzhou Red Cross Hospital | Guangzhou | Guangdong | 510235 | China |
|
| Huizhou Central People's Hospital | Huizhou | Guangdong | 516008 | China |
|
| The Second Affiliated Hospotal of Guangxi Medical University | Nanning | Guangxi | 530006 | China |
|
| Handan First Hospital | Handan | Hebei | 056002 | China |
| Hebei Petro China Cental Hospital | Langfang | Hebei | 065000 | China |
| First Hospital of Qinhuangdao | Qinhuangdao | Hebei | 066000 | China |
| The Second Hospital of Hebei Medical University | Shijiangzhuang | Hebei | 050005 | China |
|
| The Fourth Affiliated Hospital Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| The First Affiliated Hospital of Henan University of Science & Technology | Luoyang | Henan | 471000 | China |
| Luoyang Third People's Hospital | Luoyang | Henan | 471002 | China |
| The First Affiliated of Nanyang Medical College | Nanyang | Henan | 473000 | China |
| Nanyang Second People's Hospital | Nanyang | Henan | 473009 | China |
|
| Yichang Central People's Hospital | Yichang | Hubei | 443003 | China |
|
| Yueyang People's Hospital | Yueyang | Hunan | 414022 | China |
|
| Zhuzhou Central Hospital | Zhuzhou | Hunan | 412007 | China |
|
| The Second People's Hospital of Lianyungang | Lianyungang | Jiangsu | 222002 | China |
|
| Nanjing Jiangning Hospital | Nanjing | Jiangsu | 210000 | China |
| The Second Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210011 | China |
|
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221006 | China |
|
| Central Hospital Affiliated to Shandong First Medical University | Jinan | Shandong | 250000 | China |
| Zibo Municipal Hospital | Zibo | Shandong | 255400 | China |
| Xi'an Daxing Hospital | Xi’an | Shanxi | 710000 | China |
| Peking University People's Hospital | Beijing | China |
|
| 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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