Healthy ParticipantsPhase 1NCT04649710
A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants
A Phase 1 study testing BMS-986036 in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986036
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 21 Jun 2021to 22 Sep 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Conditions
- Healthy Participants
- Being tested
- BMS-986036, Placebo
- Keywords
- Chinese, Ethnicity, Korean, Obese, Overweight, Pegbelfermin
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986036Biological
Also called Pegbelfermin
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Dose 1 or placebo | Experimental | Chinese participants Receives: Biological: BMS-986036; Other: Placebo |
| Cohort 2: Dose 2 or placebo | Experimental | Chinese participants Receives: Biological: BMS-986036; Other: Placebo |
| Cohort 3: Dose 1 or placebo | Experimental | Korean participants Receives: Biological: BMS-986036; Other: Placebo |
| Cohort 4: Dose 2 or placebo | Experimental | Korean participants Receives: Biological: BMS-986036; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
Measured: 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
Measured: 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
Measured: Up to 7 days after first dose and up to 7 days after last dose
Secondary outcomes (14)
Incidence of adverse events (AEs)
Measured: Up to 45 days
Incidence of serious adverse events (SAEs)
Measured: Up to 70 days
Incidence of clinically significant changes in vital signs: Body temperature
Measured: Up to 64 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Measured: Up to 64 days
Incidence of clinically significant changes in vital signs: Blood pressure
Measured: Up to 64 days
Incidence of clinically significant changes in vital signs: Heart rate
Measured: Up to 64 days
Incidence of clinically significant changes in physical examination findings
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Measured: Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Measured: Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Measured: Up to 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start21 Jun 2021 (estimated)
- Primary completion21 Sep 2021 (estimated)
- Study completion22 Sep 2021 (estimated)
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649710
- Sponsor's protocol ID
- MB130-063
- Status last verified
- Apr 2022
- First submitted
- 25 Nov 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04649710
- Acronym / sponsor ID
- MB130-063
- Conditions
- Healthy Participants
- Keywords
- Chinese, Ethnicity, Korean, Obese, Overweight, Pegbelfermin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2021 (estimated)
- Primary completion
- 21 Sep 2021 (estimated)
- Study completion
- 22 Sep 2021 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Dose 1 or placebo | Experimental | Biological: BMS-986036, Other: PlaceboChinese participants |
| Cohort 2: Dose 2 or placebo | Experimental | Biological: BMS-986036, Other: PlaceboChinese participants |
| Cohort 3: Dose 1 or placebo | Experimental | Biological: BMS-986036, Other: PlaceboKorean participants |
| Cohort 4: Dose 2 or placebo | Experimental | Biological: BMS-986036, Other: PlaceboKorean participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986036Also: PegbelferminSpecified dose on specified days | Biological | Cohort 1: Dose 1 or placebo, Cohort 2: Dose 2 or placebo, Cohort 3: Dose 1 or placebo, Cohort 4: Dose 2 or placebo |
| PlaceboSpecified dose on specified days | Other | Cohort 1: Dose 1 or placebo, Cohort 2: Dose 2 or placebo, Cohort 3: Dose 1 or placebo, Cohort 4: Dose 2 or placebo |
Primary outcome
Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
Time frame: 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
Time frame: 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
Time frame: Up to 7 days after first dose and up to 7 days after last dose
14 secondary outcomes
Incidence of adverse events (AEs)
Time frame: Up to 45 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 70 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 64 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 64 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 64 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 64 days
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Time frame: Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
Time frame: Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Time frame: Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
Time frame: Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time frame: Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 64 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986036 in people with Healthy Participants, run by Bristol-Myers Squibb at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants (time frame: Up to 7 days after first dose and up to 7 days after last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.