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

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 liv...

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Autores principales: Connolly, James J., Ooka, Kohtaro, Lim, Joseph K.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: XIA & HE Publishing Inc. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6160309/
https://www.ncbi.nlm.nih.gov/pubmed/30271738
http://dx.doi.org/10.14218/JCTH.2017.00056
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author Connolly, James J.
Ooka, Kohtaro
Lim, Joseph K.
author_facet Connolly, James J.
Ooka, Kohtaro
Lim, Joseph K.
author_sort Connolly, James J.
collection PubMed
description 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.
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spelling pubmed-61603092018-09-28 Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials Connolly, James J. Ooka, Kohtaro Lim, Joseph K. J Clin Transl Hepatol Review Article 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. XIA & HE Publishing Inc. 2018-06-28 2018-09-28 /pmc/articles/PMC6160309/ /pubmed/30271738 http://dx.doi.org/10.14218/JCTH.2017.00056 Text en © 2018 Authors. http://creativecommons.org/licenses/by-nc/4.0/ This article has been published under the terms of Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0), which permits noncommercial unrestricted use, distribution, and reproduction in any medium, provided that the following statement is provided. “This article has been published in Journal of Clinical and Translational Hepatology at DOI: 10.14218/JCTH.2017.00056 and can also be viewed on the Journal’s website at http://www.jcthnet.com”.
spellingShingle Review Article
Connolly, James J.
Ooka, Kohtaro
Lim, Joseph K.
Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials
title Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials
title_full Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials
title_fullStr Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials
title_full_unstemmed Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials
title_short Future Pharmacotherapy for Non-alcoholic Steatohepatitis (NASH): Review of Phase 2 and 3 Trials
title_sort future pharmacotherapy for non-alcoholic steatohepatitis (nash): review of phase 2 and 3 trials
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6160309/
https://www.ncbi.nlm.nih.gov/pubmed/30271738
http://dx.doi.org/10.14218/JCTH.2017.00056
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