Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)

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.

Timeline

Start

2015-12-04

Primary completion

2017-03-21

Completion

2018-03-12

Publications

• Pockros PJ, Fuchs M, Freilich B, Schiff E, Kohli A, Lawitz EJ, Hellstern PA, Owens-Grillo J, Van Biene C, Shringarpure R, MacConell L, Shapiro D, Cohen DE. CONTROL: A randomized phase 2 study of obeticholic acid and atorvastatin on lipoproteins in nonalcoholic steatohepatitis patients. Liver Int. 2019 Nov;39(11):2082-2093. doi: 10.1111/liv.14209. Epub 2019 Sep 10.

Drugs

Indications