Trial · NCT03486912
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
NCT03486912, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2022-10-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis. Trials, record NCT03486912. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03486912
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
- NCT number
- NCT03486912
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 155 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
- Interventions
- BMS-986036, Placebo
- First posted
- 2018-04-03
- Last updated
- 2022-10-13
- Results first posted
- 2022-10-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 | From first dose to 48 weeks after first dose | An improvement in fibrosis is defined as a decrease of fibrosis by ≥1-stage in the NASH Clinical Research Network (CRN) Fibrosis Score at week 48 in liver biopsy. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease activity score (NAS) by ≥ 1-stage. Worsening of NASH is defined as an increase of the nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS) by ≥1 point. Worsening of fibrosis is defined as an increase of fibrosis by ≥1 point as determined by the NASH CRN Fibrosis Score. |
| Secondary | The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48 | From first dose to 48 weeks after first dose | An improvement in Ishak fibrosis is defined as a decrease of fibrosis by ≥ 1-stage in the Ishak fibrosis score at week 48 in liver biopsy. ISHAKs uses a 0-6 scale: 1: centrilobular pericellular fibrosis, 2: centrilobular and periportal fibrosis, 3: bridging fibrosis (few bridges), 4: bridging fibrosis (many bridges), 5: early or incomplete cirrhosis, 6: established or advanced cirrhosis. |
| Secondary | The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48 | From first dose to 48 weeks after first dose | The percentage of participants who achieved a ≥1-stage improvement in fibrosis without worsening of NASH or NASH improvement with no worsening of fibrosis at week 48 in liver biopsy. Improvement in fibrosis is defined by the NASH Clinical Research Network (CRN) Fibrosis Score. Improvement in NASH is defined by a ≥2-stage decrease in the nonalcoholic fatty liver disease activity score (NAS). NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis). |
| Secondary | The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48 | From first dose to 48 weeks after first dose | An improvement in fibrosis is defined as a decrease of ≥ 1-stage in the non-alcoholic steatohepatitis clinical research network (NASH CRN) Fibrosis Score at week 48 in liver biopsy. NASH CRN Fibrosis is staged on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal fibrosis); 2 (perisinusoidal and portal/periportal fibrosis); 3 (bridging fibrosis); 4 (cirrhosis). |
| Secondary | The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48 | From first dose to 48 weeks after first dose | An improvement in CPA is defined as any decrease in CPA at week 48 in liver biopsy. |
| Secondary | The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48 | From first dose to 48 weeks after first dose | NASH resolution defined by the nonalcoholic fatty liver disease activity score (NAS) component of ballooning = 0 and inflammation = 0-1 at week 48 in liver biopsy. Ballooning = 0 (none) inflammation = 0 (none) - 1 (Grade \<2). |
| Secondary | The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 48 | From first dose to 48 weeks after first dose | The percentage of participants with NASH improvement at week 48 in liver biopsy. NASH improvement is defined as a reduction of nonalcoholic fatty liver disease activity score (NAS) by ≥ 2 points with contribution from \> 1 NAS component. The NASH CRN system assesses liver biopsies for degree of steatosis (0-3), lobular inflammation (0-3), hepatocellular ballooning (0-2), and fibrosis (0-4). The 3 categories are added together in an unweighted fashion to determine the NAS, which ranges from 0 to 8. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 | From first dose to 48 weeks after first dose | All treated participants | Percentage of Participants | NUMBER |
| SECONDARY | The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48 | From first dose to 48 weeks after first dose | All treated participants | Percentage of Participants | NUMBER |
| SECONDARY | The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48 | From first dose to 48 weeks after first dose | All treated participants | Percentage of Participants | NUMBER |
| SECONDARY | The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48 | From first dose to 48 weeks after first dose | All treated participants | Percentage of Participants | NUMBER |
| SECONDARY | The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48 | From first dose to 48 weeks after first dose | All treated participants | Percentage of Participants | NUMBER |
| SECONDARY | The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48 | From first dose to 48 weeks after first dose | All treated participants | Percentage of Participants | NUMBER |
| SECONDARY | The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 48 | From first dose to 48 weeks after first dose | All treated participants | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 | BMS-986036 10 mg | 28.2 | Percentage of Participants | ||
| The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 | BMS-986036 20 mg | 24.3 | Percentage of Participants | ||
| The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 | BMS-986036 40 mg | 28.2 | Percentage of Participants | ||
| The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 | Placebo | 30.8 | Percentage of Participants | ||
| The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48 | BMS-986036 10 mg | 38.5 | Percentage of Participants | ||
| The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48 | BMS-986036 20 mg | 32.4 | Percentage of Participants | ||
| The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48 | BMS-986036 40 mg | 33.3 | Percentage of Participants | ||
| The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48 | Placebo | 35.9 | Percentage of Participants | ||
| The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48 | BMS-986036 10 mg | 33.3 | Percentage of Participants | ||
| The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48 | BMS-986036 20 mg | 40.5 | Percentage of Participants |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized (Pre-Treatment) | STARTED | BMS-986036 10 mg | 39 | |
| Randomized (Pre-Treatment) | STARTED | BMS-986036 20 mg | 38 | |
| Randomized (Pre-Treatment) | STARTED | BMS-986036 40 mg | 39 | |
| Randomized (Pre-Treatment) | STARTED | Placebo | 39 | |
| Randomized (Pre-Treatment) | COMPLETED | BMS-986036 10 mg | 39 | |
| Randomized (Pre-Treatment) | COMPLETED | BMS-986036 20 mg | 37 | |
| Randomized (Pre-Treatment) | COMPLETED | BMS-986036 40 mg | 39 | |
| Randomized (Pre-Treatment) | COMPLETED | Placebo | 39 | |
| Randomized (Pre-Treatment) | NOT COMPLETED | BMS-986036 10 mg | 0 | |
| Randomized (Pre-Treatment) | NOT COMPLETED | BMS-986036 20 mg | 1 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events392
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 | Palpitations | Cardiac disorders | BMS-986036 10 mg | 0 | 39 | |
| other | Palpitations | Cardiac disorders | BMS-986036 20 mg | 0 | 37 | |
| other | Palpitations | Cardiac disorders | BMS-986036 40 mg | 2 | 39 | |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 39 | |
| other | Abdominal distension | Gastrointestinal disorders | BMS-986036 10 mg | 1 | 39 | |
| other | Abdominal distension | Gastrointestinal disorders | BMS-986036 20 mg | 1 | 37 | |
| other | Abdominal distension | Gastrointestinal disorders | BMS-986036 40 mg | 4 | 39 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 1 | 39 | |
| other | Abdominal pain | Gastrointestinal disorders | BMS-986036 10 mg | 0 | 39 | |
| other | Abdominal pain | Gastrointestinal disorders | BMS-986036 20 mg | 6 | 37 |
1 to 10 of 392Source ClinicalTrials.gov
See all 392 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BMS-986036 10 mg | 1 | 39 |
| Total, all-cause mortality | BMS-986036 20 mg | 0 | 38 |
| Total, all-cause mortality | BMS-986036 40 mg | 0 | 39 |
| Total, all-cause mortality | Placebo | 1 | 39 |
| Total, other adverse events | BMS-986036 10 mg | 27 | 39 |
| Total, other adverse events | BMS-986036 20 mg | 36 | 37 |
| Total, other adverse events | BMS-986036 40 mg | 29 | 39 |
| Total, other adverse events | Placebo | 33 | 39 |
| Total, serious adverse events | BMS-986036 10 mg | 7 | 39 |
| Total, serious adverse events | BMS-986036 20 mg | 7 | 37 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
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GET https://conductscience.org/api/trials/v1/NCT03486912/results?page=2