A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Healthy Participants

Treatments: Biological: BMS-986036; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04649710

MB130-063

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Other protocol-defined inclusion/exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 4 patient groups

Cohort 1: Dose 1 or placebo

Experimental group

Description:

Chinese participants

Treatment:

Other: Placebo

Biological: BMS-986036

Cohort 2: Dose 2 or placebo

Experimental group

Description:

Chinese participants

Treatment:

Other: Placebo

Biological: BMS-986036

Cohort 3: Dose 1 or placebo

Experimental group

Description:

Korean participants

Treatment:

Other: Placebo

Biological: BMS-986036

Cohort 4: Dose 2 or placebo

Experimental group

Description:

Korean participants

Treatment:

Other: Placebo

Biological: BMS-986036