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).
The investigators propose to develop studies of obeticholic acid (OCA) in patients with bile
acid diarrhoea. OCA is a semisynthetic bile acid, also known as 6αethylchenodeoxycholic acid
or INT747,and is a potent farnesoid X receptor (FXR) agonist. Preliminary data suggests that
patients with bile acid diarrhoea have impaired production of the ileal hormone Fibroblast
Growth Factor 19 (FGF19). FGF19 is stimulated by FXR agonists, and regulates bile acid
synthesis. This study is a pilot, proof-of-concept, open-label study to investigate whether
OCA can stimulate FGF19 in bile acid diarrhoea patients to provide a safe and effective
treatment.
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