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Farnesoid X receptor (FXR) agonist

Obeticholic Acid for Familial Adenomatous Polyposis

Phase 1

Waitlist Available

Led By Eduardo Sanchez, MD, PhD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Presence of intact rectum or ileo-rectal anastomosis (IRA) or ileal pouch-anal anastomosis (IPAA)

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will test if a new drug, obeticholic acid, can help treat Familial Adenomatous Polyposis, a condition that causes growths in the colon.

Who is the study for?

Adults diagnosed with Familial Adenomatous Polyposis (FAP) having more than 100 adenomas, a family history of FAP, or specific genetic markers. Participants must have normal organ and marrow function, no active cancer for the past 6 months, and agree to use contraception. Excluded are those with severe health issues, uncontrolled hyperlipidemia, pregnant or breastfeeding women, and anyone on certain medications.Check my eligibility

What is being tested?

The trial is testing Obeticholic Acid (OCA), comparing its effects against a placebo in treating FAP. The goal is to see if OCA can improve conditions associated with FAP such as duodenal polyposis and rectal polyps.See study design

What are the potential side effects?

While not specified here, potential side effects of OCA may include itching, fatigue, abdominal pain or discomfort; however exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lower bowel is intact or I have had specific types of bowel surgery.

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I am 18 years old or older.

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I am fully active and can carry on all my pre-disease activities without restriction.

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I have FAP affecting my duodenum and rectum, confirmed by genetic or clinical diagnosis.

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My organ and bone marrow functions are normal.

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My screening showed I have moderate to severe duodenal polyps.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the effect of treatment with OCA versus treatment with placebo on duodenal polyp burden (sum of polyp diameters) in participants with FAP.

Side effects data

From 2022 Phase 2 trial • 10 Patients • NCT02430077

40%

Itching

100%

80%

60%

40%

20%

Study treatment Arm

Placebo for Obeticholic Acid

Active Capsule of Obeticholic Acid

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2: PlaceboExperimental Treatment1 Intervention

Participants will receive the study drug for 6 months

Group II: Group 1: Obeticholic AcidExperimental Treatment1 Intervention

Participants will receive the study drug for 6 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Obeticholic Acid

2015

Completed Phase 2

~130

Placebo

1995

Completed Phase 3

~2670

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,966 Previous Clinical Trials

1,804,701 Total Patients Enrolled

Eduardo Sanchez, MD, PhDPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Obeticholic Acid (Farnesoid X receptor (FXR) agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05112822 — Phase 1

Adenomatous Polyposis Research Study Groups: Group 1: Obeticholic Acid, Group 2: Placebo

Adenomatous Polyposis Clinical Trial 2023: Obeticholic Acid Highlights & Side Effects. Trial Name: NCT05112822 — Phase 1

Obeticholic Acid (Farnesoid X receptor (FXR) agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05112822 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently taking part in this clinical trial?

"Unfortunately, the recruitment period for this trial is now closed. It was initially launched in March of 2022 and last updated on November 18th 2021. If you are considering other studies, 897 trials associated with colorectal cancer have open enrollment periods and 6 investigations related to Obeticholic Acid are actively searching for participants."

Answered by AI

Are applications still being accepted for this clinical experiment?

"As detailed on clinicaltrials.gov, recruitment for this trial has been suspended - the project was first posted on March 31st 2022 and last updated November 18th 2021. Although it is not currently searching for participants, 903 other studies are actively recruiting at the moment."

Answered by AI

Has Obeticholic Acid been granted sanction by the FDA?

"Our team at Power concluded that Obeticholic Acid is relatively safe, assigning it a score of 1. This assessment was made due to its Phase 1 trial status, meaning there are limited data supporting both its efficacy and safety."

Answered by AI

Has a similar trial ever been conducted before this one?

"Since 2015, Obeticholic Acid has been the subject of extensive clinical investigation. The initial trial was conducted by Intercept Pharmaceuticals and included 2480 patients. Following a successful Phase 3 approval in 2015, there are currently 6 active studies for this drug spanning across 31 nations and 142 cities."

Answered by AI

Are there numerous sites within the state that are conducting this clinical trial?

"Currently, there are 4 locations taking part in this study - Boston, Phoenix and Ann Arbor plus an additional site. To achieve optimal convenience for participants, it is recommended to select the closest clinic available."

Answered by AI

Are there prior studies that have analyzed the effects of Obeticholic Acid?

"Obeticholic Acid was initially evaluated at the Gastroenterology Department Hull Royal Infirmary in 2015. Since then, 18337 clinical trials have been completed and 6 current studies are underway--many of which are taking place out of Boston, MA."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Testing Obeticholic Acid (OCA) for Familial Adenomatous Polyposis (FAP)

2022. "Testing Obeticholic Acid (OCA) for Familial Adenomatous Polyposis (FAP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05112822.

All > Familial Adenomatous Polyposis