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This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI362 in overweight or obese subjects. Subjects will be randomly assigned to IBI362 low-dose, high-dose and placebo groups. The entire trial cycle includes a 2-week screening period, a 48-week double-blind treatment period, and a 12-week drug withdrawal follow-up period after the end of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo,SC,once a week for 48 weeks |
|
| IBI362 4 mg | Experimental | 2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 44 weeks |
|
| IBI362 6 mg | Experimental | 2 mg,SC,once a week for 4 weeks 4 mg,SC,once a week for 4 weeks 6 mg,SC,once a week for 40 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo administered subcutaneously (SC) once a week. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 32 | |
| Percentage of Participants who Achieve ≥5% Body Weight Reduction | Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve ≥10%Body Weight Reduction | Week 32,Week 48 | |
| Percentage of Participants who Achieve ≥15% Body Weight Reduction | Week 32,Week 48 | |
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Inclusion Criteria:
• Body mass Index (BMI) ≥28 kilograms per square meter (kg/m²), or ≥24 kg/m² and with at least one of the following comorbidities: prediabetes, hypertension, dyslipidemia, fatty liver, weight bearing joint pain, obesity-related dyspnea or obstructive sleep apnea.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuancheng People's Hospital | Xuancheng | Anhui | China | |||
| People's Hospital of Peking University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40421736 | Derived | Ji L, Jiang H, Bi Y, Li H, Tian J, Liu D, Zhao Y, Qiu W, Huang C, Chen L, Zhong S, Han J, Zhang Y, Lian Q, Yang P, Lv L, Gu J, Liu Z, Deng H, Wang Y, Li L, Pei L, Qian L; GLORY-1 Investigators. Once-Weekly Mazdutide in Chinese Adults with Obesity or Overweight. N Engl J Med. 2025 Jun 12;392(22):2215-2225. doi: 10.1056/NEJMoa2411528. Epub 2025 May 25. |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| IBI362 |
| Drug |
IBI362 administered subcutaneously (SC) once a week. |
|
| Change from Baseline in Waist Circumference |
| Baseline, Week 32,Week 48 |
| Percent Change from Baseline in Body Weight | Baseline, Week 48 |
| Percentage of Participants who Achieve ≥5% Body Weight Reduction | Week 48 |
| Percentage of Participants who Achieve ≥20% Body Weight Reduction | Week 32, Week 48 |
| Change from Baseline in Neck Circumference | Baseline, Week 32, Week 48 |
| Change from Baseline in Hip Circumference | Baseline, Week 32, Week 48 |
| Change from Baseline in Body Weight | Baseline, Week 32, Week 48 |
| Percent Change from Baseline in Body Weight | Baseline, Week 60 |
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 32, Week 48 |
| Percentage of Participants with BMI < 24 kg/m2 | Week 32, Week 48 |
| Change from Baseline in Systolic Blood Pressure | Baseline, Week 32, Week 48 |
| Change from Baseline in Diastolic Blood Pressure | Baseline, Week 32, Week 48 |
| Change from Baseline in Triglyceride | Baseline, Week 32,Week 48 |
| Change from Baseline in Total Cholesterol | Baseline, Week 32, Week 48 |
| Change from Baseline in Low-density Lipoprotein Cholesterol | Baseline, Week 32, Week 48 |
| Change from Baseline in High-density Lipoprotein Cholesterol | Baseline, Week 32, Week 48 |
| Change from Baseline in Serum Uric Acid | Baseline, Week 32, Week 48 |
| Change from Baseline in Alanine Aminotransferase | Baseline, Week 32, Week 48 |
| Change from Baseline in Aspartate Aminotransferase | Baseline, Week 32, Week 48 |
| Change from Baseline in Glycated Hemoglobin A1c (HbA1c) | Baseline, Week 32, Week 48 |
| Change from Baseline in Fasting Plasma Glucose | Baseline, Week 32, Week 48 |
| Change from Baseline in Fasting Insulin | Baseline, Week 32, Week 48 |
| Change from Baseline in Fasting C-peptide | Baseline, Week 32, Week 48 |
| Change from Baseline in Homeostatic Model Assessment of Insulin Resistance-Insulin Resistance Index (HOMA2-IR) | Baseline, Week 32, Week 48 |
| Change from Baseline in IWQoL-Lite-CT Questionnaire Scores | Baseline, Week 32, Week 48 |
| Change from Baseline in SF-36v2 Questionnaire Scores | Baseline, Week 32, Week 48 |
| Beijing |
| Beijing Municipality |
| 100044 |
| China |
| Luoyang Third People's Hospital | Luoyang | He'nan | China |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang | He'nan | China |
| The First Affiliated Hospital of Nanyang Medical University | Nanyang | He'nan | China |
| The Third Affiliated Hospital of Xinxiang Medical University | Xinxiang | He'nan | China |
| Hebei Petro China Central Hospital | Langfang | Hebei | China |
| The First People's Hospital Of Kunshan | Kunshan | Jiangsu | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | China |
| Affiliated Hospital Of Nantong University | Nantong | Jiangsu | China |
| Suzhou Municipal Hospital | Suzhou | Jiangsu | China |
| Pingxiang People's Hospital | Pingxiang | Jiangxi | China |
| China-Japan Union Hospital of Jilin University | Changchun | Jilin | China |
| Shenyang Fifth People's Hospital | Shenyang | Liaoning | China |
| Jinan Central Hospital | Ji'nan | Shandong | China |
| Shandong Provincial Third Hospital | Ji'nan | Shandong | China |
| Qilu Hospital Of Shandong University (Qingdao) | Qingdao | Shandong | China |
| Tai'an Central Hospital | Tai’an | Shandong | China |
| Zibo Municipal Hospital | Zibo | Shandong | China |
| Shanxi Bethune Hospital | Taiyuan | Shanxi | China |
| Yan'an University Xianyang Hospital | Xianyang | Shanxi | China |
| Huzhou Central Hospital | Huzhou | Zhejiang | China |
| Lishui Central Hospital | Lishui | Zhejiang | China |