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

Brief Title

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

Official Title

A Phase 2B Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of BMS-986036 (PEG-FGF21) in Adults With Nonalcoholic Steatohepatitis (NASH) and Compensated Liver Cirrhosis

Brief 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).
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Proportion of participants who achieve ≥1 stage improvement in fibrosis without worsening of NASH as determined by liver biopsy

Secondary Outcome

 Proportion of participants with Ishak Score improvement as determined by liver biopsy

Condition

Hepatic Cirrhosis

Intervention

BMS-986036

Study Arms / Comparison Groups

 BMS-986036 Dose Level 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

155

Start Date

June 12, 2018

Completion Date

October 27, 2021

Primary Completion Date

October 1, 2020

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Bristol-Myers Squibb, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT03486912

Organization ID

MB130-069


Responsible Party

Sponsor

Study Sponsor

Bristol-Myers Squibb


Study Sponsor

Bristol-Myers Squibb, Study Director, Bristol-Myers Squibb


Verification Date

August 2021