Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IBI362 in Overweight or Obesity Subjects
NCT ID: NCT04440345
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2020-06-16
2021-08-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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IBI362
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.
IBI362
Administered by subcutaneous injection
placebo
Participants received matching placebo dose regiments by subcutaneous injection
Placebo
Administered by subcutaneous injection
Interventions
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IBI362
Administered by subcutaneous injection
Placebo
Administered by subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
2. Have a body mass index (BMI) ≥24 kilograms per meter squared (kg/m²) with complication, or BMI≥28 kg/m²,inclusive at screening
3. Willing and agreeable to commit to the duration of the study and undergo study procedures as instructed by the clinic staff
Exclusion Criteria
2. Have received prescription drugs or over the counter drugs that promote weight loss in the past 3 months prior to screening
3. Previous treatment with a GLP-1 (glucagon-like peptide 1) receptor agonists or GCG(glucagon)receptor agonists before.
4. Surgical treatment for obesity
5. Past or current chronic or idiopathic pancreatitis, or any of the following: -amylase or lipase above 2 times UNR (upper normal range), triglycerides above 500 mg/dL
6. Have other medical conditions or medical history that make participation in the study unsafe or which may interfere in the interpretation of the results of the study
7. Unwilling to comply with smoking and alcohol restrictions during the study
18 Years
75 Years
ALL
No
Sponsors
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Innovent Biologics (Suzhou) Co. Ltd.
INDUSTRY
Responsible Party
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Locations
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Peking University people's hospital
Beijing, , China
Countries
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References
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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.
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.
Other Identifiers
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CIBI362B101
Identifier Type: -
Identifier Source: org_study_id