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To evaluate the efficacy and dose-response relationship of HRS9531 injection compared with placebo in reducing body weight in obese subjects without diabetes after 24 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | HRS9531 injection |
|
| Treatment group B | Experimental | HRS9531 injection |
|
| Treatment group C | Experimental | HRS9531 injection |
|
| Treatment group D | Experimental | HRS9531 injection |
|
| Treatment group E | Placebo Comparator | HRS9531 injection Placebo |
|
| Treatment group F | Placebo Comparator | HRS9531 injection Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS9531 injection | Drug | HRS9531 injection: dose level 1 for 32 weeks、level 2 for 20 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage change in body weight | Percentage Change from baseline in body weight after 24 weeks of treatment | Week 0, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with weight loss of ≥5% from baseline in body weight after 24 weeks of treatment | Week 24 | |
| Proportion of subjects with weight loss of ≥10% from baseline in body weight after 24 weeks of treatment | Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The second affiliated hospital of Anhui medical university | Hefei | Anhui | 230601 | China | ||
| Peking University Third Hospital |
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A multicenter, randomized, double-blind, placebo- parallel controlled Phase II clinical study
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| Treatment group G |
| Placebo Comparator |
HRS9531 injection Placebo |
|
| Treatment group H | Placebo Comparator | HRS9531 injection Placebo |
|
| HRS9531 injection | Drug | HRS9531 injection: dose level 2 |
|
| HRS9531 injection | Drug | HRS9531 injection: dose level 3 |
|
| HRS9531 injection | Drug | HRS9531 injection: dose level 4 |
|
| HRS9531 injection Placebo | Drug | Placebo arm matching active arm HRS9531 injection dose level 1 for 32 weeks、HRS9531 injection level 2 for 20 weeks |
|
| HRS9531 injection Placebo | Drug | Placebo arm matching active arm HRS9531 injection dose level 2 for 32 weeks、HRS9531 injection level 2 for 20 weeks |
|
| HRS9531 injection Placebo | Drug | Placebo arm matching active arm HRS9531 injection dose level 3 for 32 weeks、HRS9531 injection level 2 for 20 weeks |
|
| HRS9531 injection Placebo | Drug | Placebo arm matching active arm HRS9531 injection dose level 4 for 32 weeks、HRS9531 injection level 2 for 20 weeks |
|
| Change from baseline in body weight after 24 weeks of treatment | Week 0, Week 24 |
| Change from baseline in waist circumference after 24 weeks of treatment | Week 0, Week 24 |
| Change from baseline in BMI after 24 weeks of treatment | Week 0, Week 24 |
| Change from baseline in blood pressure after 24 weeks of treatment | Week 0, Week 24 |
| Change from baseline in total cholesterol after 24 weeks of treatment | Week 0, Week 24 |
| Change from baseline in fasting plasma glucose (FPG) after 24 weeks of treatment | Week 0, Week 24 |
| Change from baseline in glycosylated haemoglobin (HbA1c) after 24 weeks of treatment | Week 0, Week 24 |
| Number of AEs During the Trial | Week 0 to Week 56 |
| Percentage change in body weight | Week 0, Week 32 |
| Proportion of Subjects with weight loss of ≥5% from baseline in body weight after 32 weeks of treatment | Week 32 |
| Proportion of Subjects with weight loss of ≥10% from baseline in body weight after 32 weeks of treatment | Week 32 |
| Change from baseline in body weight after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in waist circumference after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in BMI after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in blood pressure after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in total cholesterol after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in fasting plasma glucose (FPG) after 32 weeks of treatment | Week 0, Week 32 |
| Change from baseline in glycosylated haemoglobin (HbA1c) after 32 weeks of treatment | Week 0, Week 32 |
| Beijing |
| Beijing Municipality |
| 100191 |
| China |
| The Second Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400010 | China |
| Huadu District People's Hospital of Guangzhou | Guangzhou | Guangdong | 510800 | China |
| The people's hospital of Longhua.Shenzhen | Shenzhen | Guangdong | 518110 | China |
| Department of Endocrinology,Sencond Affiliated Hospital of Guangxi Medical University | Nanning | Guangxi | 530007 | China |
| The First Affiliated Hospital of Hainan Medical University | Haikou | Hainan | 570102 | China |
| The Fourth Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang | 150001 | China |
| The First Affiliated Hospital, and College of Clinical Medicine of Henan University of Science and Technology | Luoyang | Henan | 471000 | China |
| The First Affiliated Hospital of Nanyang Medical College | Nanyang | Henan | 473000 | China |
| The Central Hospital Of Huangshi | Huangshi | Hubei | 435000 | China |
| The Third People's Hospital of Hubei Province | Wuhan | Hubei | 430000 | China |
| Baotou Central Hospital | Baotou | Inner Mongolia | 014040 | China |
| Lianyungang Hospital of TCM | Lianyungang | Jiangsu | 222001 | China |
| The First People's Hospital Of Lianyungang | Lianyungang | Jiangsu | 222002 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | Jiangsu | 221004 | China |
| North Jiangsu People's Hospital | Yangzhou | Jiangsu | 225001 | China |
| The Second Hospital of Jilin University | Changchun | Jilin | 130022 | China |
| Shengjing Hospital Of China Medical University | Shenyang | Liaoning | 110004 | China |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200030 | China |
| Zhongshan Hospital Affiliated to Fudan University | Shanghai | Shanghai Municipality | 20032 | China |
| Second hospttoal of Shanxi medical University | Taiyuan | Shanxi | 030000 | China |
| Chengdu Second People's Hospital | Chengdu | Sichuan | 610000 | China |
| The First Affiliated Hospital of Xi'an Medical College | Xi'an | Xian | 710000 | China |
| First Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650032 | China |
| The First People's Hospital of Hangzhou | Hangzhou | Zhejiang | 310006 | 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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