deltatrials
Suspended PHASE2 INTERVENTIONAL 2-arm NCT05223036

Testing Obeticholic Acid for Familial Adenomatous Polyposis

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

Sponsor: National Cancer Institute (NCI)

Conditions Attenuated Familial Adenomatous Polyposis Colorectal Carcinoma Duodenal Carcinoma Familial Adenomatous Polyposis
Interventions Biopsy Procedure Biospecimen Collection Gastrointestinal Endoscopy Obeticholic Acid Placebo Administration Questionnaire Administration
Updated 26 times since 2022 Last updated: Mar 12, 2026 Started: Jan 19, 2023 Primary completion: Jan 31, 2029 Completion: Feb 21, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Suspended

FDA Partial Clinical Hold

This PHASE2 trial investigates Attenuated Familial Adenomatous Polyposis and Colorectal Carcinoma and is currently suspended. National Cancer Institute (NCI) leads this study, which shows 26 recorded versions since 2023 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Mar 2022 – ~Jun 2022 · 3 months · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Feb 2023 · 5 months · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~Jun 2023 · 2 months · monthly snapshot~Jun 2023 – ~Aug 2023 · 2 months · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Dec 2023 · 3 months · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~May 2024 · 3 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Mar 2025 · 59 days · monthly snapshot~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Oct 2025 · 4 months · monthly snapshot~Oct 2025 – ~Dec 2025 · 2 months · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – ~Mar 2026 · 28 days · monthly snapshot~Mar 2026 – present · 6 months · monthly snapshot

Change History

26 versions recorded

  1. Mar 2026 — Present [monthly]

    Suspended PHASE2

  2. Feb 2026 — Mar 2026 [monthly]

    Suspended PHASE2

  3. Jan 2026 — Feb 2026 [monthly]

    Suspended PHASE2

  4. Dec 2025 — Jan 2026 [monthly]

    Suspended PHASE2

  5. Oct 2025 — Dec 2025 [monthly]

    Suspended PHASE2

    Status: Recruiting → Suspended

▶ Show 21 earlier versions

  1. Jun 2025 — Oct 2025 [monthly]

    Recruiting PHASE2

  2. May 2025 — Jun 2025 [monthly]

    Recruiting PHASE2

  3. Apr 2025 — May 2025 [monthly]

    Recruiting PHASE2

  4. Mar 2025 — Apr 2025 [monthly]

    Recruiting PHASE2

  5. Jan 2025 — Mar 2025 [monthly]

    Recruiting PHASE2

  6. Sep 2024 — Jan 2025 [monthly]

    Recruiting PHASE2

  7. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  8. May 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

  9. Feb 2024 — May 2024 [monthly]

    Recruiting PHASE2

  10. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE2

  11. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE2

  12. Sep 2023 — Dec 2023 [monthly]

    Recruiting PHASE2

  13. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE2

  14. Jun 2023 — Aug 2023 [monthly]

    Recruiting PHASE2

  15. Apr 2023 — Jun 2023 [monthly]

    Recruiting PHASE2

  16. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE2

  17. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE2

  18. Sep 2022 — Feb 2023 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  19. Jul 2022 — Sep 2022 [monthly]

    Not Yet Recruiting PHASE2

  20. Jun 2022 — Jul 2022 [monthly]

    Not Yet Recruiting PHASE2

  21. Mar 2022 — Jun 2022 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
Data source: National Cancer Institute (NCI)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations