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

A Double-Blind, Multicenter, Placebo-Controlled, Randomized, Parallel, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants

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.

Study Overview

• Status: Withdrawn
• Conditions: Healthy Participants
• Intervention / Treatment: Other: Placebo; Biological: BMS-986036

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130021
      • Local Institution
• Korea, Republic of
  • Busan, Korea, Republic of, 614-735
    • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1: Dose 1 or placebo; Chinese participants	Other: Placebo; Specified dose on specified days; Biological: BMS-986036; Specified dose on specified days; Other Names: Pegbelfermin
Experimental: Cohort 2: Dose 2 or placebo; Chinese participants	Other: Placebo; Specified dose on specified days; Biological: BMS-986036; Specified dose on specified days; Other Names: Pegbelfermin
Experimental: Cohort 3: Dose 1 or placebo; Korean participants	Other: Placebo; Specified dose on specified days; Biological: BMS-986036; Specified dose on specified days; Other Names: Pegbelfermin
Experimental: Cohort 4: Dose 2 or placebo; Korean participants	Other: Placebo; Specified dose on specified days; Biological: BMS-986036; Specified dose on specified days; Other Names: Pegbelfermin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants	Up to 7 days after first dose and up to 7 days after last dose
Time of maximum observed plasma concentration (Tmax) of C-terminal intact BMS-986036 in Chinese and Korean participants	Up to 7 days after first dose and up to 7 days after last dose
Area under the concentration-time curve over 1 dosing interval (AUC (TAU)) of C-terminal intact BMS-986036 in Chinese and Korean participants	Up to 7 days after first dose and up to 7 days after last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)		Up to 45 days
Incidence of serious adverse events (SAEs)		Up to 70 days
Incidence of clinically significant changes in vital signs: Body temperature		Up to 64 days
Incidence of clinically significant changes in vital signs: Respiratory rate		Up to 64 days
Incidence of clinically significant changes in vital signs: Blood pressure		Up to 64 days
Incidence of clinically significant changes in vital signs: Heart rate		Up to 64 days
Incidence of clinically significant changes in physical examination findings		Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval	PR interval is the time from the onset of the P wave to the start of the QRS complex	Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS	QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization	Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval	The QT interval is the time from the start of the Q wave to the end of the T wave	Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF	QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave	Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests		Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests		Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests		Up to 64 days

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Anticipated): June 21, 2021
• Primary Completion (Anticipated): September 21, 2021
• Study Completion (Anticipated): September 22, 2021

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 2, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2022
• Last Update Submitted That Met QC Criteria: April 25, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Overweight; Chinese; Obese; Ethnicity; Korean; Pegbelfermin
• Additional Relevant MeSH Terms: Body Weight; Overweight
• Other Study ID Numbers: MB130-063

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes