This study is in progress, not accepting new patients

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

a study on Nonalcoholic Steatohepatitis Steatohepatitis Cirrhosis Liver Disease Nonalcoholic Fatty Liver Disease Fibrosis

Summary

Eligibility
for people ages 21-75 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

Description

Summary

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).

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)

Keywords

Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Steatohepatitis, Liver Disease, NASH, Compensated cirrhosis, Fatty Liver, Non-alcoholic Fatty Liver Disease, Fibrosis, BMS-986263

Eligibility

You can join if…

Open to people ages 21-75

  • Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 12 months
  • Men and women must agree to follow methods of contraception

You CAN'T join if...

  • 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

Locations

  • UCSD - Altman Clinical and Translational Research Institute (ACTRI)-UC San Diego NAFLD Research Cent
    La Jolla California 92037 United States
  • GastroIntestinal BioSciences
    Los Angeles California 90067 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting FDA Safety Alerts and Recalls
ID
NCT04267393
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 270 study participants
Last Updated