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Trial ID IM025-017  |   NCT04267393

Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)

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Summary

  • Phase 2
  • Male and Female Gender icon
  • 21-75
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).

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Key Eligibility Criteria

Inclusion Criteria: - Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 months - Men and women must agree to follow methods of contraception Exclusion Criteria: - Worsening liver disease or any disease might compromise participant safety in the opinion of the investigator - Known immunocompromised status or any disease or condition which might compromise participant safety - Prior exposure to BMS-986263 - Clinically relevant abnormal physical examination, vital signs, ECG, or clinical laboratory tests - Hepatic decompensation Other protocol-defined inclusion/exclusion criteria apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Dose A BMS-986263

ASSIGNED INTERVENTION
  • Drug: BMS-986263

Study Arms

Experimental: Dose B BMS-986263

ASSIGNED INTERVENTION
  • Drug: BMS-986263

Study Arms

Placebo Comparator: Placebo

ASSIGNED INTERVENTION
  • Other: Placebo