84
Participants
Start Date
December 4, 2015
Primary Completion Date
March 21, 2017
Study Completion Date
March 12, 2018
Obeticholic Acid
Once a day (QD) by mouth (PO)
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."
Placebo
Once a day (QD) by mouth (PO)
Thomas Jefferson University, Philadelphia
Mercy Medical Center, Institute for Digestive Health & Liver Disease, Baltimore
McGuire DVAMC, Richmond
Duke University Medical Center, Durham
Cumberland Research Associates, LLC, Fayetteville
Medical University of South Carolina, Charleston
University of Miamai, Schiff Center for Liver Diseases, Miami
South Florida Center of Gastroenterology, Wellington
Florida Medical Clinic, P.A., Zephyrhills
Nature Coast Clinical Research, Inverness
ClinSearch, Chattanooga
Consultants for Clinical Research, Cincinnati
St. Louis University, St Louis
Kansas City Research Institute, Kansas City
Texas Clinical Research Institute, LLC, Arlington
Liver Associates of Texas, P.A., Houston
American Research Corporation at the Texas Liver Institute, San Antonio
St. Joseph's Hospital and Medical Center, Phoenix
Scripps Clinic, La Jolla
Inland Empire Liver Foundation, Rialto
The Queen's Medical Center - Liver Center, Honolulu
University Gastroenterology Liver Center, Providence
Lead Sponsor
Intercept Pharmaceuticals
INDUSTRY