Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Review
. 2020 Jan;21(1):3-11.
doi: 10.1111/1751-2980.12830. Epub 2019 Dec 11.

Development of new drugs for the treatment of nonalcoholic steatohepatitis

Jie Ting Tang  1 , Yi Min Mao  1
Affiliations
Review

Development of new drugs for the treatment of nonalcoholic steatohepatitis

Jie Ting Tang et al. J Dig Dis. 2020 Jan.

Abstract

The development of new drugs for nonalcoholic steatohepatitis (NASH) is a current focus of research in the management of liver disease. Here we provided an overview of NASH drug pipelines and the challenges faced in conducting phases II and III clinical trials. These challenges include the selection and definition of research populations, rational selection of study end-points, choice of noninvasive diagnostic indicators, accounting for confounding factors and safety assessments. Furthermore, we discussed how to establish guidelines for study design and end-points in complex clinical trials of anti-NASH drugs.

Keywords: clinical trial; drug design; nonalcoholic steatohepatitis.

PubMed Disclaimer

References

REFERENCES

    1. Fabbrini E, Sullivan S, Klein S. Obesity and nonalcoholic fatty liver disease: biochemical, metabolic, and clinical implications. Hepatology. 2010;51(2):679-689.
    1. Targher G, Day CP, Bonora E. Risk of cardiovascular disease in patients with nonalcoholic fatty liver disease. N Engl J Med. 2010;363(14):1341-1350.
    1. Hamaguchi M, Kojima T, Takeda N, et al. The metabolic syndrome as a predictor of non-alcoholic fatty liver disease. Ann Intern Med. 2005;143(10):722-728.
    1. Younossi ZM, Koenig AB, Abdelatif D, Fazel Y, Henry L, Wymer M. Global epidemiology of nonalcoholic fatty liver disease-Meta-analytic assessment of prevalence, incidence, and outcomes. Hepatology. 2016;64(1):73-84.
    1. Parikh ND, Marrero WJ, Wang J, et al. Projected increase in obesity and non-alcoholic steatohepatitis-related liver transplantation waitlist additions in the United States. Hepatology. 2019;70(2):487-495.

MeSH terms

LinkOut - more resources