NCT02633956

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Intercept Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Obeticholic Acid	Once a day (QD) by mouth (PO)
DRUG	Atorvastatin	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.
DRUG	Placebo	Once a day (QD) by mouth (PO)

Timeline

• Start date: 2015-12-04
• Primary completion: 2017-03-21
• Completion: 2018-03-12
• First posted: 2015-12-17
• Last updated: 2018-06-04
• Results posted: 2018-06-04

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study