A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants
NCT ID: NCT04649710
Last Updated: 2022-04-28
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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WITHDRAWN
PHASE1
INTERVENTIONAL
2021-06-21
2021-09-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Cohort 1: Dose 1 or placebo
Chinese participants
BMS-986036
Specified dose on specified days
Placebo
Specified dose on specified days
Cohort 2: Dose 2 or placebo
Chinese participants
BMS-986036
Specified dose on specified days
Placebo
Specified dose on specified days
Cohort 3: Dose 1 or placebo
Korean participants
BMS-986036
Specified dose on specified days
Placebo
Specified dose on specified days
Cohort 4: Dose 2 or placebo
Korean participants
BMS-986036
Specified dose on specified days
Placebo
Specified dose on specified days
Interventions
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BMS-986036
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Additional criterion for Chinese participants: must be first generation Chinese (born in China and not living outside of China for \> 10 years, and both parents are ethnically Chinese)
* Additional criterion for Korean participants: must be first generation Korean (born in Korea and not living outside of Korea for \> 10 years, and both parents are ethnically Korean)
* Must agree to follow specific methods of contraception, if applicable
Exclusion Criteria
* Women who are pregnant or breastfeeding
* History of allergy to pegylated compounds or fibroblast growth factor 21-related compounds
18 Years
65 Years
ALL
Yes
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Changchun, Jilin, China
Local Institution
Busan, , South Korea
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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MB130-063
Identifier Type: -
Identifier Source: org_study_id
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