Endpoints and clinical trial design for nonalcoholic steatohepatitis

UNLABELLED: Nonalcoholic fatty liver disease is a common cause of chronic liver disease in the general population. Nonalcoholic steatohepatitis (NASH), the aggressive form of nonalcoholic fatty liver disease, is associated with an increased risk of liver-related mortality and cardiovascular disease. At present, a liver biopsy is the only generally acceptable method for the diagnosis of NASH and assessment of its progression toward cirrhosis. Although several treatments have shown evidence of efficacy in clinical trials of varying design, there are no approved treatments for NASH, and published trials are often too divergent to allow meaningful comparisons. There is thus a lack of established noninvasive,…

• EL
  Eli Lilly and Company
• AA
  American Association for the Study of Liver Diseases
• TP
  Teva Pharmaceutical Industries
• NI
  National Institutes of Health
• NC
  National Cancer Institute