938 Positive Results From REGENERATE: A Phase 3 International, Randomized, Placebo-Controlled Study Evaluating Obeticholic Acid Treatment for NASH

INTRODUCTION: Obeticholic acid (OCA), an FXR agonist, improved both fibrosis and histologic features of nonalcoholic steatohepatitis (NASH) in the Ph2 FLINT study. This Month 18 pre-specified interim analysis of the Ph3 REGENERATE study evaluated the effect of OCA on liver histology in patients (pts) with biopsy-confirmed NASH 1 . METHODS: Pts with NASH and fibrosis stages F2-3 (ITT), and an exploratory group of F1 pts with metabolic syndrome,...