Testing Obeticholic Acid for Familial Adenomatous Polyposis

ClinicalTrials.gov ID: NCT05223036

Public ClinicalTrials.gov record NCT05223036. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 7, 2026, 2:42 AM EDT

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Official title

A Phase IIa, Placebo-Controlled, Randomized Study of Daily Obeticholic Acid (OCA) to Reduce Intestinal Polyp Burden in Familial Adenomatous Polyposis (FAP)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This phase IIa trial investigates if giving obeticholic acid (OCA) is safe and has a beneficial 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 a bile acid the body makes. It is fluid made and released by the liver. OCA 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) for use at a lower dose (10 mg). 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.

Study identification

NCT ID: NCT05223036
Recruitment status: Terminated
Study type: Interventional
Phase: Phase 2
Lead sponsor: National Cancer Institute (NCI); NIH
Enrollment: 15 participants

Conditions and interventions

Conditions

Interventions

Procedure · Biological · Drug + 1 more

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Jan 18, 2023
Primary completion: Mar 16, 2026
Completion: Apr 16, 2026
Last update posted: May 13, 2026

2023 – 2026

United States locations

U.S. sites: 6
U.S. states: 6
U.S. cities: 6

Facility	City	State	ZIP	Site status
Mayo Clinic in Arizona	Scottsdale	Arizona	85259	—
University of Kansas Cancer Center	Kansas City	Kansas	66160	—
Dana-Farber Cancer Institute	Boston	Massachusetts	02215	—
University of Michigan Rogel Cancer Center	Ann Arbor	Michigan	48109	—
Cleveland Clinic Foundation	Cleveland	Ohio	44195	—
M D Anderson Cancer Center	Houston	Texas	77030	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05223036, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 13, 2026 · Synced Sep 7, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05223036 live on ClinicalTrials.gov.

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