The double blind, placebo controlled, multi-center clinical study will evaluate the effects of OCA compared with placebo in adult NASH patients.
The 72-week study will enroll 280 patients at eight centres across the US.
The primary endpoint will be determined by liver biopsy and is defined as an improvement in the nonalcoholic fatty liver disease score with no worsening of liver fibrosis.
The National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health is providing the majority of the funding for this study and is partnering with Intercept under a cooperative research and development agreement.