The purpose of this guidance is to assist sponsors in the clinical development of drugs for the  treatment of nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. 

This guidance describes the Food and Drug Administration’s (FDA’s) current recommendations  regarding the important components of a drug development program for compensated NASH  cirrhosis. This guidance focuses on the enrollment criteria, trial design, efficacy endpoints, and safety considerations for phase 3 trials. This guidance also identifies knowledge gaps that  represent important challenges in the development of drugs for this indication.