Trial · NCT02413372
A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
NCT02413372, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2020-01-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH). Trials, record NCT02413372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02413372
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of BMS-986036 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
- NCT number
- NCT02413372
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 184 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Non-Alcoholic Steatohepatitis
- Interventions
- BMS-986036, BMS-986036, Placebo
- First posted
- 2015-04-09
- Last updated
- 2021-02-26
- Results first posted
- 2020-01-28
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | 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. |
| Primary | Number of Participants With Adverse Events (AEs) | From first dose to date of last dose plus 30 days | The number of participants with on-study AEs was reported for each arm. |
| Primary | Number of Participants With Serious Adverse Events (SAEs) | From first dose to date of last dose plus 30 days | The number of participants with on-study SAEs was reported for each arm. |
| Primary | Number of Participants With Injection Site Reactions | 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. |
| Primary | Number of Participants With Adverse Events Leading to Discontinuation | 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. |
| Primary | Number of Deaths | From first dose to date of last dose plus 30 days | The number of deaths was reported for each arm. |
| Primary | Number of Participants With Marked Laboratory Abnormalities | 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. |
| Primary | Number of Participants With Vital Sign Abnormalities | 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. |
| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities | 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. |
| Primary | Number of Participants With Physical Examination Abnormalities | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | From Day 1 to Day 112 | All treated participants | percentage | MEAN |
| PRIMARY | Number of Participants With Adverse Events (AEs) | From first dose to date of last dose plus 30 days | All treated participants | Participants | NUMBER |
| PRIMARY | Number of Participants With Serious Adverse Events (SAEs) | From first dose to date of last dose plus 30 days | All treated participants | Participants | NUMBER |
| PRIMARY | Number of Participants With Injection Site Reactions | From first dose to date of last dose plus 30 days | All treated participants | Participants | NUMBER |
| PRIMARY | Number of Participants With Adverse Events Leading to Discontinuation | From first dose to date of last dose plus 30 days | All treated participants | Participants | NUMBER |
| PRIMARY | Number of Deaths | From first dose to date of last dose plus 30 days | All treated participants | Participants | NUMBER |
| PRIMARY | Number of Participants With Marked Laboratory Abnormalities | From first dose to date of last dose plus 30 days | All treated participants | Participants | NUMBER |
| PRIMARY | Number of Participants With Vital Sign Abnormalities | From first dose to date of last dose plus 30 days | All treated participants | Participants | NUMBER |
| PRIMARY | Number of Participants With Electrocardiogram (ECG) Abnormalities | From first dose to date of last dose plus 30 days | All treated participants | Participants | NUMBER |
| PRIMARY | Number of Participants With Physical Examination Abnormalities | From first dose to date of last dose plus 30 days | All treated participants | Participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | BMS-986036 10 mg QD | Day 57 | -8.43 | 90% Confidence Interval -9.81 to -7.06 | percentage |
| Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | BMS-986036 20 mg QW | Day 57 | -6.45 | 90% Confidence Interval -7.90 to -5.00 | percentage |
| Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | Placebo QD | Day 57 | -1.26 | 90% Confidence Interval -2.58 to 0.06 | percentage |
| Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | BMS-986036 10 mg QD | Day 112 | -6.77 | 90% Confidence Interval -8.64 to -4.91 | percentage |
| Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | BMS-986036 20 mg QW | Day 112 | -5.20 | 90% Confidence Interval -7.13 to -3.26 | percentage |
| Mean Change in Percent Hepatic Fat Fraction (%) by Magnetic Resonance Imaging (MRI) From Baseline to Week 16 | Placebo QD | Day 112 | -1.35 | 90% Confidence Interval -3.13 to 0.43 | percentage |
| Number of Participants With Adverse Events (AEs) | BMS-986036 10 mg QD | 18 | Participants | ||
| Number of Participants With Adverse Events (AEs) | BMS-986036 20 mg QW | 13 | Participants | ||
| Number of Participants With Adverse Events (AEs) | Placebo QD | 15 | Participants | ||
| Number of Participants With Serious Adverse Events (SAEs) | BMS-986036 10 mg QD | 1 | Participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment | STARTED | BMS-986036 10 mg QD | 25 | |
| Treatment | STARTED | BMS-986036 20 mg QW | 24 | |
| Treatment | STARTED | Placebo QD | 26 | |
| Treatment | COMPLETED | BMS-986036 10 mg QD | 24 | |
| Treatment | COMPLETED | BMS-986036 20 mg QW | 22 | |
| Treatment | COMPLETED | Placebo QD | 25 | |
| Treatment | NOT COMPLETED | BMS-986036 10 mg QD | 1 | |
| Treatment | NOT COMPLETED | BMS-986036 20 mg QW | 2 | |
| Treatment | NOT COMPLETED | Placebo QD | 1 | |
| Follow-up | STARTED | BMS-986036 10 mg QD | 22 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events54
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Constipation | Gastrointestinal disorders | BMS-986036 10 mg QD | 1 | 25 | |
| other | Constipation | Gastrointestinal disorders | BMS-986036 20 mg QW | 0 | 24 | |
| other | Constipation | Gastrointestinal disorders | Placebo QD | 2 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | BMS-986036 10 mg QD | 3 | 25 | |
| other | Diarrhoea | Gastrointestinal disorders | BMS-986036 20 mg QW | 5 | 24 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo QD | 2 | 26 | |
| other | Frequent bowel movements | Gastrointestinal disorders | BMS-986036 10 mg QD | 5 | 25 | |
| other | Frequent bowel movements | Gastrointestinal disorders | BMS-986036 20 mg QW | 0 | 24 | |
| other | Frequent bowel movements | Gastrointestinal disorders | Placebo QD | 0 | 26 | |
| other | Nausea | Gastrointestinal disorders | BMS-986036 10 mg QD | 4 | 25 |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BMS-986036 10 mg QD | 0 | 25 |
| Total, all-cause mortality | BMS-986036 20 mg QW | 0 | 24 |
| Total, all-cause mortality | Placebo QD | 0 | 26 |
| Total, other adverse events | BMS-986036 10 mg QD | 13 | 25 |
| Total, other adverse events | BMS-986036 20 mg QW | 10 | 24 |
| Total, other adverse events | Placebo QD | 11 | 26 |
| Total, serious adverse events | BMS-986036 10 mg QD | 1 | 25 |
| Total, serious adverse events | BMS-986036 20 mg QW | 0 | 24 |
| Total, serious adverse events | Placebo QD | 1 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30554783 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02413372
GET https://conductscience.org/api/trials/v1/NCT02413372/results?page=2