Intercept Pharmaceuticals has initiated patient enrolment in a clinical trial to evaluate its first-in-class farnesoid X receptor agonist, obeticholic acid (OCA or INT-747), as a treatment for non-alcoholic steatohepatitis.
The double-blind, placebo-controlled, multi-centre clinical study will evaluate the effects of OCA compared with placebo in adults with non-alcoholic steatohepatitis.
The 72-week study will enrol 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 non-alcoholic fatty liver disease score with no worsening of liver fibrosis.
The National Institute of Diabetes and Digestive and Kidney Diseases, part of the National Institutes of Health, is providing the majority of the funding for the study. It is partnering with Intercept under a cooperative research and development agreement.
Non-alcoholic steatohepatitis is a more serious form of non-alcoholic fatty liver disease. It is associated with fibrosis in the liver, which can lead to cirrhosis and liver cancer.
