Overview of Clinical Treatment Trials for NASH

Abstract

Purpose of Review

Non-alcoholic fatty liver disease (NAFLD) is one of the most prominent forms of chronic liver disease. Non-alcoholic steatohepatitis (NASH) represents a subgroup of patients with steatosis and necro-inflammation with or without fibrosis. Currently, there are no FDA-approved therapies. This review provides an overview of treatments in clinical trials for NAFLD and NASH.

Recent Findings

Therapies aimed at reducing hepatic steatosis focus on lipogenesis, insulin resistance, and metabolism of free fatty acids. Therapeutics targeting necro-inflammation have focused on pathways of immune activation and hepatocyte injury, while anti-fibrotic agents have focused on preventing fibrosis development via actions on stellate cells or reducing existing fibrosis.

Summary

There are multiple agents in mid-to-late stage clinical trials to treat NAFLD and NASH. Many have shown promising results. If safety and efficacy are established, these medications will provide a much needed pharmacologic treatment approach for this burgeoning patient population.

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Correspondence to Monica A. Konerman.

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Conflict of Interest

Monica A. Konerman declares no potential conflicts of interest.

Stephen A. Harrison is a consultant/advisor to Gilead, Intercept, Genfit, HistoIndex, Axcella, BMS, Pfizer, Madrigal, NGM Bio, Cirius, Novartis, Novo Nordisk, Chronic Liver Disease Foundation, Echosens, and Perspectum. He has received research support from Gilead, Intercept, Genfit, Cirius, Madrigal, NGM Bio, Conatus, Galmed, Immuron, and Tobira/Allergan. Dr. Harrison is a section editor for Current Hepatology Reports.

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All reported studies/experiments with human or animal subjects performed by the authors have been previously published and complied with all applicable ethical standards (including the Helsinki declaration and its amendments, institutional/national research committee standards, and international/national/institutional guidelines).

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This article is part of the Topical Collection on Fatty Liver Disease

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Konerman, M.A., Harrison, S.A. Overview of Clinical Treatment Trials for NASH. Curr Hepatology Rep 16, 366–373 (2017). https://doi.org/10.1007/s11901-017-0375-5

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Keywords

  • Non-alcoholic steatohepatitis
  • Clinical trials
  • Fibrosis
  • Hepatitis
  • Steatosis