72
Participants
Start Date
March 21, 2022
Primary Completion Date
September 1, 2025
Study Completion Date
September 1, 2025
Bezafibrate 100 mg
One tablet of bezafibrate 100 mg IR once daily
Bezafibrate 200 mg
Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR
Obeticholic Acid 5 mg
One tablet of obeticholic acid 5 mg tablet once daily.
Obeticholic Acid placebo
One tablet of obeticholic acid placebo tablet once daily
Bezafibrate Placebo
One tablet of bezafibrate placebo tablet once daily
Wake Endoscopy Center, Raleigh
Piedmont Atlanta Hospital, Atlanta
Schiff Center for Liver Diseases / University of Miami, Miami
Tampa General Medical Group, Tampa
University of Alabama at Birmingham, Birmingham
Gastrointestinal Associates of Northeast Tennessee, Johnson City
Gastro One, Cordova
University Hospitals Cleveland Medical Center, Cleveland
Loyola University Medical Center, Maywood
Ochsner Medical Center, New Orleans
Methodist Clinical Research Institute (CRI), Dallas
American Research Corporation at the Texas Liver Institute, San Antonio
Facey Medical Group, Mission Hills
Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado, Coronado
Beth Israel Deaconess Medical Center Harvard Liver Research Center, Boston
NYU Langone Medical Center, New York
Houston Methodist Cancer Center, Houston
Hospital Italiano La Plata, La Plata
DIM Clinical Privada, Ramos Mejía
Hospital Italiano de Buenos Aires, Buenos Aires
Hospital Universitario Austral, Pilar
Hospital Provincial del Centenario, Rosario
University of Montreal, Montreal
Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi, Bologna
The Northern Alberta Clinical Trials and Research Centre, Edmonton
Pacific Gastroenterology Associates, Vancouver
Lead Sponsor
Intercept Pharmaceuticals
INDUSTRY