Journal of Clinical and Translational Hepatology

Journal of Clinical and Translational Hepatology

Sunday, 12 / 16 / 2018

Articles

Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials

REVIEW ARTICLE

Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials

James J. Connolly1, Kohtaro Ooka2 and Joseph K. Lim*,3

1Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA
2Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh Medical Center, Pittsburgh, PA, USA
3Yale Liver Center, Section of Digestive Diseases, Yale University School of Medicine, New Haven, CT, USA

*Correspondence to: Joseph K. Lim, Yale Liver Center, Section of Digestive Diseases, Yale University School of Medicine, 333 Cedar Street, LMP 1080, New Haven, CT 06520-8019, USA. Tel: +1-203-737-6063, Fax: +1-203-785-7273, E-mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Journal of Clinical and Translational Hepatology 2018;6(3):264-275 DOI: 10.14218/JCTH.2017.00056
Received: August 18, 2017 Accepted: April 4, 2018 Published online: June 28, 2018

Abstract

Non-alcoholic steatohepatitis (NASH) results from inflammation and hepatocyte injury in the setting of hepatic steatosis. Non-alcoholic steatohepatitis increases the risk of progression to liver fibrosis and cirrhosis, and is the most rapidly growing etiology for liver failure and indication for liver transplantation in the USA. Weight loss and lifestyle modification remain the standard first-line treatment, as no USA Food and Drug Administration-approved pharmacotherapy currently exists. The past decade has seen an explosion of interest in drug development targeting pathologic pathways in non-alcoholic steatohepatitis, with numerous phase 2 and 3 trials currently in progress. Here, we concisely review the major targets and mechanisms of action by class, summarize results from completed pivotal phase 2 studies, and provide a detailed outline of key active studies with trial data for drugs in development, including obeticholic acid, elafibranor, cenicriviroc and selonsertib.

Keywords

Fatty liver, Non-alcoholic steatohepatitis, Clinical trials, Pharmacotherapy, Obeticholic acid

 

 

 

Journal of Clinical and Translational Hepatology 2018 vol. 6, 264-275  [ Html ] [ PDF Full-text ]

 

© The Authors 2018. This article is published under the terms of the Creative Commons Attribution-Noncommercial License (CC BY-NC 4.0), which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license.

 

 logo

You are here: Home