Mary E Rinella, Hsiao D Lieu, Kris V Kowdley, Zachary D Goodman, Naim Alkhouri, Eric Lawitz, Vlad Ratziu, Manal F Abdelmalek, Vincent Wai-Sun Wong, Ziad H Younes, Aasim M Sheikh, Donald Brannan, Bradley Freilich, Fernando Membreno, Marie Sinclair, Liza Melchor-Khan, Arun J Sanyal, Lei Ling, Stephen A Harrison
BACKGROUND AND AIMS: Aldafermin, an engineered analog of the human hormone FGF19, improves liver histology in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH), however, its efficacy and safety in compensated cirrhosis is unknown. No drug has yet to demonstrate benefit in the compensated NASH population. APPROACH AND RESULTS: In this multicenter, double-blind, placebo-controlled, phase 2b trial, 160 patients with compensated NASH cirrhosis were randomized to aldafermin 0...
September 21, 2023: Hepatology: Official Journal of the American Association for the Study of Liver Diseases