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

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-21

Study Completion Date

2021-09-22

Brief Summary

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The purpose of this study is to evaluate the safety, tolerability, and drug level of Pegbelfermin in healthy overweight and obese Chinese and Korean participants.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Cohort 1: Dose 1 or placebo

Chinese participants

Group Type EXPERIMENTAL

BMS-986036

Intervention Type BIOLOGICAL

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Cohort 2: Dose 2 or placebo

Chinese participants

Group Type EXPERIMENTAL

BMS-986036

Intervention Type BIOLOGICAL

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Cohort 3: Dose 1 or placebo

Korean participants

Group Type EXPERIMENTAL

BMS-986036

Intervention Type BIOLOGICAL

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Cohort 4: Dose 2 or placebo

Korean participants

Group Type EXPERIMENTAL

BMS-986036

Intervention Type BIOLOGICAL

Specified dose on specified days

Placebo

Intervention Type OTHER

Specified dose on specified days

Interventions

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BMS-986036

Specified dose on specified days

Intervention Type BIOLOGICAL

Placebo

Specified dose on specified days

Intervention Type OTHER

Other Intervention Names

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Pegbelfermin

Eligibility Criteria

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Inclusion Criteria

* Overweight and obese, but otherwise healthy Chinese and Korean participants, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* 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

* BMI ≥ 40 kg/m\^2
* Women who are pregnant or breastfeeding
* History of allergy to pegylated compounds or fibroblast growth factor 21-related compounds
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Local Institution

Busan, , South Korea

Site Status

Countries

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China South Korea

Related Links

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Other Identifiers

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MB130-063

Identifier Type: -

Identifier Source: org_study_id

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