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NCT06488911 · ClinicalTrials.gov registry record · Phase 3
To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate
A Phase 3 study, sponsored by Intercept Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 62
- Enrollment target
NCT06488911: Clinical Trial Phase 3 study, sponsored by Intercept Pharmaceuticals.
NCT06488911 is a Phase 3 study that was terminated before completion, run by Intercept Pharmaceuticals. The registered enrollment target is 62 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06488911, a Phase 3 study, was terminated before completion, sponsored by Intercept Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 62 participants
- Enrollment target
Study Summary
An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
Primary Outcome
A TEAE was defined as any event not present before the initiation of the investigational product in this study or any event already present, which worsened in either severity or frequency following exposure to the investigational product in this study. A serious TEAE was defined as any untoward medical occurrence that at any dose resulted in death, life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/in
Interventions
- DRUG FDC tablet (OCA 5 mg + BZF 400 mg SR)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2024-07-01 |
| Est. Completion | 2025-10-21 |
| Phase | Phase 3 |
Why NCT06488911 stopped before completion
NCT06488911 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which FDC tablet (OCA 5 mg + BZF 400 mg SR) is the first listed.
NCT06488911 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06488911 about?
NCT06488911 is a clinical study titled "To Evaluate Safety and Tolerability of the Fixed- Dose Combination of Obeticholic Acid and Bezafibrate". An Open Label Long-Term Study to Evaluate the Safety and Tolerability of the Fixed-Dose Combination (FDC) of Obeticholic Acid (OCA) and Bezafibrate (BZF) tablet in Subjects with Primary Biliary Cholangitis (PBC).
What is the current status of trial NCT06488911?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 62 participants. The study started on 2024-07-01. Estimated completion is 2025-10-21.
What interventions are being tested in trial NCT06488911?
The interventions under investigation include: FDC tablet (OCA 5 mg + BZF 400 mg SR) (DRUG).
Who is sponsoring clinical trial NCT06488911?
This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06488911's enrollment target sits among peer trials
62 1802nd of 2000 higher than 198 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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