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

• Status: Recruiting
• Trial end date: 2024-07-23
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb

Criteria

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

Inclusion Criteria:

• Participants with liver biopsy fibrosis score stage 4 (NASH CRN) performed within 6 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