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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Nonalcoholic Steatohepatitis (NASH)

In brief

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).

Key facts

Study ID

NCT04267393

Run by

Bristol-Myers Squibb

People needed

124

Starts

2021-03-17

Expected to finish

2024-02-09

Last updated by the study team

2024-09-04

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Local Institution - 0173 — Chandler, Arizona, United States
• The Institute for Liver Health-The Institute for Liver Health — Chandler, Arizona, United States
• Local Institution — Phoenix, Arizona, United States
• Local Institution - 0140 — La Jolla, California, United States
• Local Institution - 0205 — Lancaster, California, United States
• GastroIntestinal BioSciences — Los Angeles, California, United States
• Local Institution - 0143 — Redwood City, California, United States
• Florida Research Institute — Lakewood Rch, Florida, United States
• Local Institution - 0024 — Leesburg, Florida, United States
• Local Institution - 0061 — Miami, Florida, United States
• Local Institution - 0025 — Winter Park, Florida, United States
• Local Institution - 0121 — Iowa City, Iowa, United States
• Local Institution - 0150 — Baltimore, Maryland, United States
• Local Institution — Fall River, Massachusetts, United States
• Local Institution - 0077 — Kansas City, Missouri, United States
• Local Institution - 0186 — Omaha, Nebraska, United States
• Research Foundation of SUNY - University of Buffalo — Buffalo, New York, United States
• NYU Langone Health-Department of Medicine — New York, New York, United States
• Local Institution — New York, New York, United States
• Local Institution - 0206 — Morehead City, North Carolina, United States
• Local Institution - 0177 — Philadelphia, Pennsylvania, United States
• Local Institution - 0017 — Philadelphia, Pennsylvania, United States
• University Diabetes & Endocrine Consultants — Chattanooga, Tennessee, United States
• Local Institution - 0171 — Dallas, Texas, United States
• Arizona Clinical Trials - Tucson — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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