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This trial is conducted in China. The aim of this trial is to investigate Safety, Tolerability, PK and PD for Multiple Doses of IBI362 in Overweight or Obese Male and Female Subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IBI362 | Experimental | Participants received dose 1 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 2 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 3 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 4 level of IBI362 administered as multiple subcutaneous doses. Participants received dose 5 level of IBI362 administered as multiple subcutaneous doses. |
|
| placebo | Placebo Comparator | Participants received matching placebo dose regiments by subcutaneous injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IBI362 | Drug | Administered by subcutaneous injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment adverse events | The relationship of each adverse event to the investigational product was assessed by the investigator. | From the time of first dosing (Day 1 ) until completion of the post treatment follow-up visit (20 week) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Anti-IBI362 Antibodies | Serum samples were analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples were subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies. | From the time of first dosing (Day 1 )until comletion of the post treatment follow-up visit (20 week) |
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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 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36247927 | Derived | Ji L, Gao L, Jiang H, Yang J, Yu L, Wen J, Cai C, Deng H, Feng L, Song B, Ma Q, Qian L. Safety and efficacy of a GLP-1 and glucagon receptor dual agonist mazdutide (IBI362) 9 mg and 10 mg in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple-ascending-dose phase 1b trial. EClinicalMedicine. 2022 Oct 7;54:101691. doi: 10.1016/j.eclinm.2022.101691. eCollection 2022 Dec. | |
| 34430840 |
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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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| ID | Term |
|---|---|
| C000719829 | mazdutide |
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| Drug |
Administered by subcutaneous injection |
|
| Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in overweight or obesity subjects; | From the first dose (Day 1 ) of study drug until 12 week |
| Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in overweight or obesity subjects; | From the first dose (Day 1 ) of study drug until 12 week |
| Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in overweight or obesity subjects; | From the first dose (Day 1 ) of study drug until 12 week |
| Evaluate the Glucagon of IBI362 in overweight or obesity subjects; | From the first dose (Day 1 ) of study drug until 12 week |
| Evaluate the Insulin of IBI362 in overweight or obesity subjects; | From the first dose (Day 1 ) of study drug until 12 week |
| Evaluate the C-peptide of IBI362 in overweight or obesity subjects; | From the first dose (Day 1 ) of study drug until 12 week |
| Change in body weight from baseline | Baseline (Day 1 ) and 12 week for groups |
| Derived |
| Ji L, Jiang H, An P, Deng H, Liu M, Li L, Feng L, Song B, Han-Zhang H, Ma Q, Qian L. IBI362 (LY3305677), a weekly-dose GLP-1 and glucagon receptor dual agonist, in Chinese adults with overweight or obesity: A randomised, placebo-controlled, multiple ascending dose phase 1b study. EClinicalMedicine. 2021 Aug 13;39:101088. doi: 10.1016/j.eclinm.2021.101088. eCollection 2021 Sep. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |