NCT04649710

Brief Summary

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2021

Shorter than P25 for phase_1

Geographic Reach
2 countries

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

June 21, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2021

Completed
Last Updated

April 28, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

November 25, 2020

Last Update Submit

April 25, 2022

Conditions

Healthy Participants

Keywords

ChineseEthnicityKoreanObeseOverweightPegbelfermin

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (4)

Cohort 1: Dose 1 or placebo

EXPERIMENTAL

Chinese participants

Biological: BMS-986036Other: Placebo

Cohort 2: Dose 2 or placebo

EXPERIMENTAL

Chinese participants

Biological: BMS-986036Other: Placebo

Cohort 3: Dose 1 or placebo

EXPERIMENTAL

Korean participants

Biological: BMS-986036Other: Placebo

Cohort 4: Dose 2 or placebo

EXPERIMENTAL

Korean participants

Biological: BMS-986036Other: Placebo

Interventions

BMS-986036BIOLOGICAL

Specified dose on specified days

Also known as: Pegbelfermin
Cohort 1: Dose 1 or placeboCohort 2: Dose 2 or placeboCohort 3: Dose 1 or placeboCohort 4: Dose 2 or placebo
PlaceboOTHER

Specified dose on specified days

Cohort 1: Dose 1 or placeboCohort 2: Dose 2 or placeboCohort 3: Dose 1 or placeboCohort 4: Dose 2 or placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Local Institution

Changchun, Jilin, 130021, China

Location

Local Institution

Busan, 614-735, South Korea

Location

Related Links

MeSH Terms

Conditions

ObesityOverweight

Interventions

Pegbelfermin

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2020

First Posted

December 2, 2020

Study Start

June 21, 2021

Primary Completion

September 21, 2021

Study Completion

September 22, 2021

Last Updated

April 28, 2022

Record last verified: 2022-04

Locations

KR(1)CN(1)