Clinical Trial Landscape in NASH.
Abstract
Nonalcoholic fatty liver disease (NAFLD) consists of a spectrum starting from NAFLD that may progress to, nonalcoholic steatohepatitis (NASH) which can lead to fibrosis, cirrhosis, hypercellular carcinoma, or even liver failure. The prevalence of NASH has increased in parallel with the rising rate of obesity and type 2 diabetes. Given the high prevalence and deadly complications of NASH, there have been significant efforts to develop effective treatments. Phase 2A studies have assessed various mechanisms of action across the spectrum of the disease, while phase 3 studies have focused mainly on NASH and fibrosis stage two and higher, as these patients have a higher risk of disease morbidity and mortality. The primary efficacy endpoints also varies, by using noninvasive tests in early phase trials while relying on liver histological endpoints in phase 3 studies as required by regulatory agencies. Despite initial disappointment due to the failure of several drugs, recent phase 2 and 3 studies have shown promising results, with the first FDA approved drug for NASH expected to be approved in 2023. In this review, we discussed the various drugs under development for NASH, their mechanisms of action, and the results of their clinical trials. We also highlight the potential challenges in developing pharmacological therapies for NASH.
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