Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)
Completed
Intercept Pharmaceuticals
Phase 2
2008-01-17
The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline
phosphatase levels in PBC participants, over a 12-week treatment period, as compared to
placebo.
The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)
Completed
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase 2
2011-03-01
Administration of the farnesoid X receptor (FXR) ligand obeticholic acid (OCA) for 72 weeks
to subjects with biopsy evidence of nonalcoholic steatohepatitis (NASH) will result in
improvement in their liver disease as measured by changes in the nonalcoholic fatty liver
disease (NAFLD) activity score (NAS).
Phase 3 Study of Obeticholic Acid in Patients With Primary Biliary Cirrhosis
Completed
Intercept Pharmaceuticals
Phase 3
2012-01-01
The main objectives of the study were to assess the effects of Obeticholic Acid (OCA) on
serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint and on
safety in participants with primary biliary cirrhosis (PBC).
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