Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)
Status:
Completed
Trial end date:
2018-03-12
Target enrollment:
Participant gender:
Summary
This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an
open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid,
and the subsequent addition of statin therapy, on lipoprotein metabolism in subjects with
nonalcoholic steatohepatitis (NASH) with fibrosis stage 1 to 4, but no evidence of hepatic
decompensation.