A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Liver Cirrhosis

Phase 2

Completed

• Conditions: Hepatic Cirrhosis, Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis

• Registration Number: JPRN-jRCT2080223974
• Lead Sponsor: Bristol-Myers Squibb K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-04
• Study Completion: 2022-03-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Liver biopsy performed within 6 months prior to the Screening Visit; if not performed within 6 months prior to the Screening Visit, a liver biopsy will be performed during the Screening Period and at least 4 weeks prior to randomization. Biopsy must be consistent with NASH and cirrhosis 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 dosing regimens for at least 3 months prior to the Screening Visit
Participants taking vitamin E at doses more than 800 IU/day must have been on stable doses for at least 6 months prior to the Screening Visit (Vitamin E treatment must not have been initiated after the liver biopsy was performed)

Other protocol defined inclusion criteria could apply

Exclusion Criteria

Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus infection, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, alpha-1-antitrypsin deficiency, iron overload, and hemochromatosis)
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 exclusion criteria could apply

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
efficacy<br>Proportion of participants who achieve more than 1 stage improvement in fibrosis without worsening of NASH as determined by liver biopsy [Time Frame: 48 weeks]<br>NASH Clinical Research Network (CRN) Fibrosis Score [Fibrosis measured on a 0-4 scale: 0 (none); 1 (perisinusoidal or periportal); 2 (perisinusoidal and portal/periportal); 3 (bridging fibrosis); 4 (cirrhosis)] [Time Frame: 48 weeks]<br>NAFLD Activity Score (NAS) [NASH disease activity in the liver measured on a 0-8 scale: unweighted sum of steatosis, or fat (scale: 0-3), lobular inflammation (scale: 0-3), and hepatocellular ballooning (scale: 0-2)] [Time Frame: 48 weeks]

Secondary Outcome Measures

Name	Time	Method
safety<br>efficacy<br>exploratory<br>pharmacokinetics<br>pharmacodynamics<br>pharmacogenomics<br>Proportion of participants with Ishak Score improvement as determined by liver biopsy [ Time Frame: 48 weeks ]<br>Proportion of participants with a more than 1 stage improvement in fibrosis without worsening of NASH or NASH improvement as determined by liver biopsy [ Time Frame: 48 weeks ]<br>Proportion of participants with a decrease in collagen propionate area (CPA) as determined by liver biopsy [ Time Frame: 48 weeks ]<br>Proportion of participants with NASH resolution as determined by liver biopsy [ Time Frame: 48 weeks ]<br>Proportion of participants with NASH improvement as determined by liver biopsy [ Time Frame: 48 weeks ]<br>Number of adverse events (AE) [ Time Frame: Up to 52 weeks ]