Safety, pharmacokinetics and pharmacodynamics of obeticholic acid in subjects with fibrosis or cirrhosis from NASH.
Rohit L LoombaCarl LaCerteJeffrey EdwardsFred PoordadEric LawitzLois LeeSharon KaranSangeeta SawhneyMary EricksonLeigh MacConellLuna ZaruJianfen ChenJason CampagnaPublished in: Liver international : official journal of the International Association for the Study of the Liver (2024)
Despite higher drug exposures in subjects with NASH cirrhosis, short-term daily treatment with OCA 10 or 25 mg was generally safe and well tolerated in subjects with NASH fibrosis or NASH CP-A cirrhosis. Both cohorts experienced improvements in nonhistologic pharmacodynamic markers consistent with previously conducted OCA phase 2 and phase 3 studies in NASH fibrosis.