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Clin Mol Hepatol. 2019 Mar;25(1):1-11. English. Clinical Trial. https://doi.org/10.3350/cmh.2018.0037
Yoo JJ , Kim W , Kim MY , Jun DW , Kim SG , Yeon JE , Lee JW , Cho YK , Park SH , Sohn JH .
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, Korea.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hanyang University Seoul Hospital, Seoul, Korea.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Korea.
Department of Internal Medicine, Inha University School of Medicine, Incheon, Korea.
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea. choyk2004.cho@samsung.com
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hallym University Kangnam Sacred Heart Hospital, Seoul, Korea. sanghoon@hallym.or.kr
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Korea. sonjh@hanyang.ac.kr
Abstract

Nonalcoholic fatty liver disease (NAFLD), together with metabolic syndrome and obesity, has shown a rapid increase in prevalence worldwide and is emerging as a major cause of chronic liver disease and liver transplantation. Among the various phenotypes of NAFLD, nonalcoholic steatohepatitis (NASH) is highly likely to progress to development of end-stage liver disease and cardiometabolic disease, resulting in liver-related and non-liver–related mortality. Nonetheless, there is no standardized pharmacotherapy against NASH and many drugs are under development in ongoing clinical trials. To develop a successful anti-NASH drug, it is necessary to select an appropriate target population and treatment outcomes depending on whether the mode of action is anti-metabolic, anti-inflammatory or anti-fibrotic. Recently, innovative surrogate markers have been investigated to replace hard outcomes such as liver histology and mortality and reduce the clinical trial duration. Currently, several drugs with fast track designation are being tested in phase III clinical trials, and many other drugs have moved into phase II clinical trials. Both lean NAFLD and typical obese NAFLD have been extensively studied and genetic variants such as PNPLA3 and TM6SF2 have been identified as significant risk factors for lean NAFLD. In the near future, noninvasive biomarkers and effective targeted therapies for NASH and associated fibrosis are required to develop precision medicine and tailored therapy according to various phenotypes of NAFLD.

Copyright © 2019. Korean Association of Medical Journal Editors.