Clinical trialNCT04939051RecruitingPhase 2Interventional

Obeticholic Acid for Prevention in Barrett's Esophagus

SponsorNational Cancer Institute (NCI)Enrollment30Barrett EsophagusEsophageal Adenocarcinoma

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Prashanthi Thota
University of Michigan Rogel Cancer Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of Kansas Cancer Center
Kansas City, Kansas, United States
Ajay Bansal
Recruiting
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Scott M. Schuetze →
Recruiting
Washington University School of Medicine
St Louis, Missouri, United States
Dayna S. Early
Recruiting
Unc Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Nicholas J. Shaheen
Recruiting
Case Western Reserve University
Cleveland, Ohio, United States
Amitabh Chak
Recruiting
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Prashanthi Thota
Recruiting
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Joseph E. Willis
Not, yet, recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Amitabh Chak
Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Obeticholic acid →Placebo Administration

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 3 Jan 2024
Primary completion: 1 Sept 2027
Completion: 1 Sept 2027
Last update posted: 11 Aug 2026
Registered enrollment: 30
Registry id: NCT04939051

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.