Phase 2
N=197
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
Liver Fibrosis · Nonalcoholic Fatty Liver Disease (NAFLD) · Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT03486899 ↗Enrolled (actual)
197
Serious AEs
12.7%
Results posted
Sep 2022
Primary outcome: Primary: The Percentage of Participants With Improvement in Fibrosis or Nonalcoholic Steatohepatitis (NASH) at Week 24 — 30.6; 24.0; 26.5; 14.3 Percentage of Participants — p=0.055
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- BMS-986036 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Sep 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants With Improvement in Fibrosis or Nonalcoholic Steatohepatitis (NASH) at Week 24 |
30.6; 24.0; 26.5; 14.3 | 0.055 |
| SECONDARY The Percentage of Participants Who Achieved an Improvement in Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Fibrosis Score at Week 24 |
16.3; 14.0; 20.4; 8.2 | 0.214 |
| SECONDARY The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 24 |
22.4; 16.0; 26.5; 12.2 | 0.180 |
| SECONDARY The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 24 |
42.9; 53.5; 55.8; 65.9 | 0.038 sig |
| SECONDARY The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis at Week 24 |
8.2; 4.0; 2.0; 6.1 | 0.718 |
| SECONDARY The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 24 |
8.2; 4.0; 2.0; 6.1 | 0.718 |
| SECONDARY The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement Without Worsening of Fibrosis at Week 24 |
22.4; 14.0; 16.3; 10.2 | 0.101 |
| SECONDARY The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 24 |
16.3; 14.0; 16.3; 8.2 | 0.214 |
| SECONDARY The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 24 |
24.5; 18.0; 16.3; 10.2 | 0.060 |
| SECONDARY The Percentage of Participants With Progression to Cirrhosis at Week 24 |
30.6; 22.0; 28.6; 20.4 | 0.242 |
Summary
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage 3 liver fibrosis (severe fibrosis).
Eligibility Criteria
Inclusion Criteria
- Liver biopsy performed within 6 months (26 weeks) prior to the screening period. If historical biopsy is not available, a liver biopsy will be performed during the screening period. Biopsy must be consistent with NASH, with: a) a score of at least 1 for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed by the central reader, and b) stage 3 liver fibrosis according to the NASH CRN classification, as assessed by the central reader
- Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable regimens for at least 3 months (12 weeks) (6 weeks for statins) prior to and during the screening period
- Participants taking vitamin E at doses greater than or equal to (>=) 800 IU/day must have been on stable doses for at least 6 months (26 weeks) prior to and during the Screening Period. Vitamin E treatment (>=800 IU/day) must not have been initiated after the qualifying liver biopsy was performed.
Exclusion Criteria
- Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus [HCV] infection, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, α-1-antitrypsin deficiency, iron overload, and hemochromatosis); participants with HCV sustained viral response (undetectable HCV RNA) for at least 2 years prior to biopsy confirming study eligibility may be eligible
- Current or past history of hepatocellular carcinoma (HCC)
- Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver transplantation
Other protocol defined inclusion/exclusion criteria could apply
Data sourced from ClinicalTrials.gov (NCT03486899). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.