Non-Alcoholic SteatohepatitisPhase 2NCT03400163
A Sub-study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
A Phase 2 study testing BMS-986036 in people with Non-Alcoholic Steatohepatitis, run by Bristol-Myers Squibb at 2 sites in United States.
Trial summary
The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH) Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Non-Alcoholic Steatohepatitis
- What is being tested?
- BMS-986036
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2015to 19 Jun 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 21 and 75 years old
- Body Mass Index (BMI) of 25 or more
Who cannot join
- Chronic Liver disease other than NASH
- Uncontrolled diabetes
- Any major surgery within 6 weeks of screening
- Unable to self-administer under the skin injections
- Any bone trauma, fracture or bone surgery within 8 weeks of screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Texas Liver Institute
San Antonio, Texas, 78215
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Sub-study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Adults With Non-alcoholic Steatohepatitis
The purpose of this sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH)
- Conditions
- Non-Alcoholic Steatohepatitis
- Being tested
- BMS-986036, Placebo
- Keywords
- First Line Therapy, NASH
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986036Drug
BMS-986036 20 mg QD
PlaceboDrug
Placebo QD
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group D: | Experimental | Administered as specified on specified days Receives: Drug: BMS-986036 |
| Treatment Group E: | Placebo comparator | Administered as specified on specified days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16
The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement.
Measured: From Day 1 to Day 112
Number of Participants With Adverse Events (AEs)
The number of participants with on-study AEs was reported for each arm.
Measured: From first dose to date of last dose plus 30 days
Number of Participants With Serious Adverse Events (SAEs)
The number of participants with on-study SAEs was reported for each arm.
Measured: From first dose to date of last dose plus 30 days
Number of Participants With Injection Site Reactions
The number of participants with on-study injection site reactions was reported for each arm.
Measured: From first dose to date of last dose plus 30 days
Number of Participants With Adverse Events Leading to Discontinuation
The number of participants with on-study AEs leading to discontinuation was reported for each arm.
Measured: From first dose to date of last dose plus 30 days
Number of Deaths
The number of deaths was reported for each arm.
Measured: From first dose to date of last dose plus 30 days
Number of Participants With Marked Laboratory Abnormalities
The number of participants whose worst toxicity grade increased from baseline to grade 3 or 4 (Toxicity Scale: DAIDS Version 1.0) is reported for each arm.
Measured: From first dose to date of last dose plus 30 days
Number of Participants With Vital Sign Abnormalities
The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm.
Measured: From first dose to date of last dose plus 30 days
Number of Participants With Electrocardiogram (ECG) Abnormalities
The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm.
Measured: From first dose to date of last dose plus 30 days
Number of Participants With Physical Examination Abnormalities
The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm.
Measured: From first dose to date of last dose plus 30 days
Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)
The mean percent change in bone mineral density from baseline to day 112 reported for each arm.
Measured: From Day 1 to Day 112
Secondary outcomes (3)
Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112
The observed serum concentration of BMS-986036 before the next dose is administered (pre-dose concentration) was assessed for both C-terminal intact and total molecule. Geometric means are presented for each arm.
Measured: From Day 1 to Day 112
Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142
Participants were monitored for antibodies to study medication using a validated ADA homogenous bridge assay with BMS-986036 and electrochemical luminescence detection. The number of treated participants with positive Anti-BMS-986036 antibody titers up to Day 142 with regards to baseline was reported for each arm.
Measured: From Day 1 to Day 142
Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142
Participants were monitored for antibodies to FGF21 using a validated homogenous bridge assay with Met-FGF21 (recombinant produced) and electrochemical luminescence detection. The number of treated participants with positive Anti-FGF21 antibody titers up to Day 142 with regards to baseline was reported for each arm.
Measured: From Day 1 to Day 142
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study start8 May 2015
- Primary completion18 Jan 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Non-Alcoholic SteatohepatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3 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
- NCT03400163
- Sponsor's protocol ID
- MB130-045 A
- Status last verified
- Feb 2021
- First submitted
- 2 Jan 2018
- Last updated
- 26 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multiple Dose Sub-study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamic Effects of BMS-986036 in Adults With Non-alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT03400163
- Acronym / sponsor ID
- MB130-045 A
- Conditions
- Non-Alcoholic Steatohepatitis
- Keywords
- First Line Therapy, NASH
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 8 May 2015 (actual)
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 17 Jan 2018 (actual)
- Results
- Posted 19 Feb 2020
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 sub-study of MB130-045 is to determine the pharmacokinetic effects, pharmacodynamic effects, efficacy and safety of BMS-986036 20 mg QD in subjects with Non-alcoholic Steatohepatitis (NASH)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group D: | Experimental | Drug: BMS-986036Administered as specified on specified days |
| Treatment Group E: | Placebo comparator | Drug: PlaceboAdministered as specified on specified days |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female between 21 and 75 years old
- Body Mass Index (BMI) of 25 or more
Key exclusion criteria (5 listed)
- Chronic Liver disease other than NASH
- Uncontrolled diabetes
- Any major surgery within 6 weeks of screening
- Unable to self-administer under the skin injections
- Any bone trauma, fracture or bone surgery within 8 weeks of screening
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-986036BMS-986036 20 mg QD | Drug | Treatment Group D: |
| PlaceboPlacebo QD | Drug | Treatment Group E: |
Primary outcome
Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16
Time frame: From Day 1 to Day 112
The mean change in percent hepatic fat fraction (%) by MRI from baseline to Week 16 was assessed for each arm. A longitudinal repeated measures analysis was used to analyze the change in hepatic fat fraction (%) at Week 16 from baseline in the treated population who have both a baseline and at least one post-baseline measurement.
Number of Participants With Adverse Events (AEs)
Time frame: From first dose to date of last dose plus 30 days
The number of participants with on-study AEs was reported for each arm.
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From first dose to date of last dose plus 30 days
The number of participants with on-study SAEs was reported for each arm.
Number of Participants With Injection Site Reactions
Time frame: From first dose to date of last dose plus 30 days
The number of participants with on-study injection site reactions was reported for each arm.
Number of Participants With Adverse Events Leading to Discontinuation
Time frame: From first dose to date of last dose plus 30 days
The number of participants with on-study AEs leading to discontinuation was reported for each arm.
Number of Deaths
Time frame: From first dose to date of last dose plus 30 days
The number of deaths was reported for each arm.
Number of Participants With Marked Laboratory Abnormalities
Time frame: From first dose to date of last dose plus 30 days
The number of participants whose worst toxicity grade increased from baseline to grade 3 or 4 (Toxicity Scale: DAIDS Version 1.0) is reported for each arm.
Number of Participants With Vital Sign Abnormalities
Time frame: From first dose to date of last dose plus 30 days
The number of participants with out-of-range vital signs noted during interim or final vital sign assessments was reported for each arm.
Number of Participants With Electrocardiogram (ECG) Abnormalities
Time frame: From first dose to date of last dose plus 30 days
The number of participants with out-of-range ECG intervals observed during interim or final electrocardiogram assessments was reported for each arm.
Number of Participants With Physical Examination Abnormalities
Time frame: From first dose to date of last dose plus 30 days
The number of participants with abnormalities observed during interim or final physical examination assessments is reported for each arm.
Mean Percent Change From Baseline in Bone Mineral Density by Dual Energy X-Ray Absorptiometry (DXA)
Time frame: From Day 1 to Day 112
The mean percent change in bone mineral density from baseline to day 112 reported for each arm.
3 secondary outcomes
Geometric Mean of Trough Observed Plasma Concentration (Ctrough) of BMS-986036 at Day 112
Time frame: From Day 1 to Day 112
Number of Participants With Positive Anti-BMS-986036 Antibody (ADA) Response at Day 142
Time frame: From Day 1 to Day 142
Number of Participants With Positive Anti-FGF21 Antibody Response at Day 142
Time frame: From Day 1 to Day 142
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-986036 in people with Non-Alcoholic Steatohepatitis, run by Bristol-Myers Squibb at 2 sites in United States.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 26 Feb 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 (time frame: From Day 1 to Day 112). The study lists 11 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 26 Feb 2021.