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This is a multicenter, double-blind, randomized, placebo-controlled study conducted in overweight or obese subjects. This study is divided into the first stage and the second stage. The participant enrollment and data analysis in the two stage are independent and do not influence each other.
In the first stage of this study, about 240 subjects will be enrolled. Qualified subjects will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 low dose, IBI362 moderate dose, IBI362 high dose groups, in every group, subjects will be randomized to IBI362 and placebo groups at a ratio of 3:1. Random stratification is performed based on BMI < 28.0 kg/㎡ and BMI≥28.0 kg/㎡. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a-24 week double-blind treatment period, and a 12-week drug discontinuation follow-up period. During the entire research period, the subjects shall maintain diet and exercise control.
The second stage is IBI362 extra high dose study, about 80 subjects will be enrolled. Qualified participants will receive placebo in a 2-week introduction period, after that, they will be randomized to IBI362 extra high dose and placebo groups at a ratio of 3:1. The subjects received drug administration once weekly. The entire trial covers a 3-week screening period, a 2-week placebo introduction period, a 24-week double-blind treatment period, a 24-week extended treatment period, and a 12-week drug discontinuation follow-up period. The 24-week extended treatment period is optional. During the entire research period, the subjects shall maintain diet and exercise control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI362 high dose | Experimental | high dose IBI362 administered subcutaneously (SC) once a week. |
|
| IBI362 low dose | Experimental | Low dose IBI362 administered subcutaneously (SC) once a week. |
|
| placebo | Placebo Comparator | placebo administered subcutaneously (SC) once a week. |
|
| IBI362 moderate dose | Experimental | moderate dose IBI362 administered subcutaneously (SC) once a week. |
|
| IBI362 extra high dose | Experimental | extra high dose IBI362 administered subcutaneously (SC) once a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI362 | Drug | IBI362 administered subcutaneously (SC) once a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Percent Change from Baseline in Body Weight | Baseline ,week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants who Achieve ≥5% Body Weight Reduction | Baseline, Week 24 | |
| Percentage of Participants who Achieve ≥10% Body Weight Reduction | Baseline, Week 24 | |
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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 | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41875890 | Derived | Ji L, Jiang H, Cheng Z, Li X, Pang S, Zhang Y, Qiu W, Ma Q, Liu Z, Wang Y, Deng H, Du H, Han-Zhang H, Qian L. Mazdutide 9 mg in Chinese adults with a body mass index >/=30 kg/m2 but without diabetes: A phase 2 randomized controlled trial. Med. 2026 May 8;7(5):101063. doi: 10.1016/j.medj.2026.101063. Epub 2026 Mar 23. | |
| 38092790 | Derived |
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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| placebo | Other | placebo administered subcutaneously (SC) once a week. |
|
| Absolute change from Baseline in body weight |
| Baseline, Week 24 |
| Change from Baseline in Waist Circumference | Baseline, Week 24 |
| Change from Baseline in BMI | Baseline, Week 24 |
| Change from Baseline in HbA1c | Baseline, Week 24 |
| Change from Baseline in fasting plasma glucose | Baseline, Week 24 |
| Change from Baseline in systolic blood pressure | Baseline, Week 24 |
| Change from Baseline in diastolic blood pressure | Baseline, Week 24 |
| Change from Baseline in total cholesterol | Baseline, Week 24 |
| Change from Baseline in low-density lipoprotein cholesterol | Baseline, Week 24 |
| Change from Baseline in high-density lipoprotein cholesterol | Baseline, Week 24 |
| Change from Baseline in triglyceride | Baseline, Week 24 |
| Change from Baseline in serum uric acid | Baseline, Week 12, Week 24 |
| Change from Baseline in IWQoL-Lite-CT questionnaire scores | Baseline, Week 24 |
| Ji L, Jiang H, Cheng Z, Qiu W, Liao L, Zhang Y, Li X, Pang S, Zhang L, Chen L, Yang T, Li Y, Qu S, Wen J, Gu J, Deng H, Wang Y, Li L, Han-Zhang H, Ma Q, Qian L. A phase 2 randomised controlled trial of mazdutide in Chinese overweight adults or adults with obesity. Nat Commun. 2023 Dec 14;14(1):8289. doi: 10.1038/s41467-023-44067-4. |