A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis

Purpose

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).

Conditions

  • Liver Fibrosis
  • Nonalcoholic Fatty Liver Disease (NAFLD)
  • Nonalcoholic Steatohepatitis

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BMS-986036 Dose Level 1 		Administered by subcutaneous injection.
  • Drug: BMS-986036
    Specified dose on specified days.
    Other names:
    • Pegbelfermin
Experimental
BMS-986036 Dose Level 2 		Administered by subcutaneous injection.
  • Drug: BMS-986036
    Specified dose on specified days.
    Other names:
    • Pegbelfermin
Experimental
BMS-986036 Dose Level 3 		Administered by subcutaneous injection.
  • Drug: BMS-986036
    Specified dose on specified days.
    Other names:
    • Pegbelfermin
Placebo Comparator
Placebo 		Administered by subcutaneous injection.
  • Other: Placebo
    Specified dose on specified days.

More Details

Status
Completed
Sponsor
Bristol-Myers Squibb

Study Contact