Testing the Drug Obeticholic Acid for Familial Adenomatous Polyposis identifier:
NCT05223036 (

Prevention study for people with an APC mutation and FAP or AFAP who have polyps in remaining tissue after colectomy surgery

Study Contact Information:

Contact: Eduardo Vilar-Sanchez
713-563-4743 [email protected]

About the Study

This study is looking at whether obeticholic acid (OCA) is safe and has a beneficial effect on the number of polyps in the small bowel and colon in people with familial adenomatous polyposis (FAP). OCA is a drug similar to a bile acid the body's liver makes. Researchers believe OCA may help keeping cancer from developing. OCA is already FDA approved to treat a type of liver disease. 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.

What the Study Involves

Participants will be divided into two groups:

All participants will undergo GI endoscopy with biopsy and collection of blood samples at screening and on study.

After completion of the study treatment, patients are followed within 14-21 days.

Study Locations


Boston, MA
Dana-Farber Cancer Institute
Contact: Ramona M. Lim
617-582-7777 [email protected] 


Ann Arbor, MI
University of Michigan Comprehensive Cancer Center
Contact: Elena M. Stoffel
734-615-9712 [email protected]


Cleveland, OH
Cleveland Clinic Foundation
Contact: Carol A. Burke
216-444-7000 [email protected]


Houston, TX
MD Anderson Cancer Center
Contact: Eduardo Vilar-Sanchez
713-563-4743 [email protected]

Puerto Rico

San Juan, PR
University of Puerto Rico
Contact: Marcia R. Cruz-Correa
787-758-2525 [email protected]

This Study is Open To:

This study is open to people over 18 years who: 

See for the full list of inclusion criteria

This Study is Not Open To:

People with the following are not eligible:

See for the full list of exclusion criteria


FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.