At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double Blind, Placebo Controlled Clinical Study Investigating the Effects of Obeticholic Acid and Atorvastatin Treatment on Lipoprotein Metabolism in Subjects With Nonalcoholic Steatohepatitis
In Brief
A Phase 2 clinical trial evaluating Obeticholic Acid, Atorvastatin, and 1 other intervention for Nonalcoholic Steatohepatitis. Completed, enrolled 84 participants across 22 sites.
Detailed 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.
Study Details
Timeline
Interventions
Once a day (QD) by mouth (PO)
Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO). Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated. Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.
Once a day (QD) by mouth (PO)