Obeticholic Acid for the Treatment of Nonalcoholic Steatohepatitis: Interim Results

Obeticholic acid, a farnesoid X receptor agonist, is currently FDA approved for the treatment of primary biliary cholangitis. To assess its safety and efficacy for nonalcoholic steatohepatitis (NASH), for which it is not currently FDA approved, researchers are conducting an ongoing industry-funded, phase III study in patients with NASH. Interim results at 18 months' follow-up (of a planned minimum of 4 years) are now reported.

The study includes 1968 patients with a nonalcoholic fatty liver disease activity score ≥4 and fibrosis stage 2 or 3 or stage 1 with at least one associated comorbidity, who were randomized to receive obeticholic acid (10 mg or 25 mg) or placebo daily. The interim intention-to-treat analysis includes 933 patients with …