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NAFLD, NASH
NONALCOHOLIC FATTY LIVER DISEASE, PATHOPHYSIOLOGY, CHRONIC LIVER DISEASE, DISEASE
Nonalcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwideDevelopment of NASH treatments presents a myriad of unique challenges due to the complex pathophysiology of the disease, and there are currently no approved pharmacological therapiesThe FXR is a nuclear receptor that is physiologically activated by bile acids and is expressed at high levels in the liver and intestineTropifexor is a selective, non-bile-acid FXR agonist that has shown high potency of target engagement and treatment efficacy in animal models of NASHThe results of FLIGHT-FXR, a phase 2 randomized, multicenter, double-blind, three-part study with adaptive design, are presented here. Safety, tolerability and efficacy of multiple, once-daily doses of tropifexor in patients with NASH versus placebo for 12 (Parts A and B) or 48 weeks (Part C) were examined. As per a planned analysis, data from Parts A and B have been pooled and expressed as ‘Parts A + B’ in this publication.