Intercept announces results from Control trial
Intercept Pharmaceuticals announced results from CONTROL, a placebo-controlled trial to prospectively characterize the lipid metabolic effects of obeticholic acid, or OCA, and concomitant statin administration in patients with nonalcoholic steatohepatitis, or NASH, with fibrosis or cirrhosis. The CONTROL trial met its primary objective by showing that newly initiated treatment with atorvastatin rapidly reversed OCA-associated increases in LDL to below baseline levels. Most of the effect was observed four weeks after initiation of the lowest available dose of atorvastatin and was sustained throughout the study period. CONTROL is a 16-week double-blind, placebo-controlled, dose-ranging study of 84 NASH patients with fibrosis and compensated cirrhosis, followed by a two-year long term safety extension, or LTSE, open label phase which is currently ongoing. Lipid changes were assessed every four weeks over the course of the double-blind phase.