Testing Obeticholic Acid for Familial Adenomatous Polyposis
Status:
Not yet recruiting
Trial end date:
2025-09-28
Target enrollment:
Participant gender:
Summary
This phase IIa trial investigates if giving obeticholic acid (OCA) has an effect on the
number of polyps in the small bowel and colon in patients with familial adenomatous polyposis
(FAP). FAP is a rare gene defect that increases the risk of developing cancer of the
intestines and colon. OCA is a drug similar to bile acids, a fluid made and released by the
liver. It binds to a receptor in the intestine that is believed to have a positive effect on
preventing cancer development. OCA has been effective in treating primary biliary cholangitis
(PBC), a liver disease, and is approved by the Food and Drug Administration (FDA). There have
been studies showing that OCA decreases inflammation and fibrosis. However, it is not yet
known whether OCA works on reducing the number of polyps in patients with FAP.