Younossi ZM, Ratziu V, Loomba R, et al. - In this multicentre, randomized, double-blind, placebo-controlled study, adult individuals with definite non-alcoholic steatohepatitis (NASH), non-alcoholic fatty liver disease (NAFLD) activity score of at least 4, and fibrosis stages F2–F3, or F1 with at least one accompanying comorbidity, were randomized using an interactive web response system to receive oral placebo, obeticholic acid 10 mg, or obeticholic acid 25 mg daily in order to report results from a planned interim analysis of an ongoing, phase 3 study of obeticholic acid for NASH. A total of 1,968 individuals with stage F1–F3 fibrosis were recruited and received at least one dose of study treatment. Fibrosis and important components of NASH disease activity were enhanced significantly by obeticholic acid 25 mg among individuals with NASH. The results from this planned interim analysis revealed a clinically important histological enhancement that is reasonably suitable to prognosticate clinical benefit. Nonetheless, this study is ongoing to evaluate clinical outcomes.