20%-30% of people with non-alcoholic fatty liver disease (NAFLD) gradually progress to non-alcoholic steatohepatitis (NASH) by which stage it is characterised by inflammation and liver damage, including various stages of fibrosis. NASH is massively under-diagnosed, partly because it is a silent disease with few, often-mild symptoms and partly because definitive diagnosis is by histopathology of a liver biopsy which the treating physician or patient may prefer not to perform and/or provide.
The therapeutic needs are tremendous worldwide as the number of NASH cases continue to expand, in conjunction with the ongoing obesity and diabetes epidemic. Over the next decade the disease is projected to become the leading indication for liver transplant. With no approved drug treatment there is an increased interest from the pharmaceutical industry, regulatory authorities and investigators to facilitate the development of new therapies that decrease the severity of NASH.
ICON offers expertise in the development and management of all aspects of NASH clinical trials from the earliest development to the late post – marketing environment. Our clinical trial experience includes: