Phase 2
N=155
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis
Hepatic Cirrhosis · Liver Fibrosis · Nonalcoholic Fatty Liver Disease (NAFLD) · Nonalcoholic Steatohepatitis
Bottom Line
View on ClinicalTrials.gov: NCT03486912 ↗Enrolled (actual)
155
Serious AEs
16.2%
Results posted
Oct 2022
Primary outcome: Primary: The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 — 28.2; 24.3; 28.2; 30.8 Percentage of Participants — p=0.773
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
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 48 |
28.2; 24.3; 28.2; 30.8 | 0.773 |
| SECONDARY The Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Ishak Fibrosis Score at Week 48 |
38.5; 32.4; 33.3; 35.9 | 0.836 |
| SECONDARY The Percentage of Participants With Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) or NASH Improvement at Week 48 |
33.3; 40.5; 35.9; 30.8 | 0.837 |
| SECONDARY The Percentage of Participants Who Achieved >=1 Point Improvement in Fibrosis at Week 48 |
35.9; 29.7; 28.2; 33.3 | 0.864 |
| SECONDARY The Percentage of Participants With Any Improvement in Collagen Proportionate Area (CPA) at Week 48 |
61.8; 54.2; 41.9; 53.1 | 0.477 |
| SECONDARY The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Resolution at Week 48 |
2.6; 5.4; 2.6; 0.0 | 0.309 |
| SECONDARY The Percentage of Participants With Nonalcoholic Steatohepatitis (NASH) Improvement at Week 48 |
15.4; 24.3; 12.8; 2.6 | 0.054 |
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 liver cirrhosis (liver damage characterized by normal liver tissue being replaced by scar tissue).
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 and cirrhosis according to the NASH CRN classification, as assessed by the central reader
- Must be 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 infection [HCV], 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
- Medical history of gastroesophageal varices, except if esophagogastroduodenoscopy [EGD] performed within 12 months prior to the Screening Period has shown <= Grade 1 varices
Other protocol-defined inclusion/exclusion criteria apply
Data sourced from ClinicalTrials.gov (NCT03486912). 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.