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NCT05239468 · ClinicalTrials.gov registry record · Phase 2
Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC
A Phase 2 study, sponsored by Intercept Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT05239468: Completed Phase 2 study, sponsored by Intercept Pharmaceuticals.
NCT05239468 is a Phase 2 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05239468, a Phase 2 study, has completed, sponsored by Intercept Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
Primary Outcome
Serum samples were collected at scheduled visits during the double-blind treatment period. Changes in ALP were evaluated using a mixed-effects repeated-measures model (MMRM) to assess the effects of treatment groups over time. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product. Change from Baseline was calculated as post Baseline value minus Baseline value.
Interventions
- DRUG Bezafibrate 100 mg
- DRUG Bezafibrate 200 mg
- DRUG Obeticholic Acid 5 mg
- DRUG Obeticholic Acid placebo
- DRUG Bezafibrate Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2022-03-21 |
| Est. Completion | 2025-09-01 |
| Phase | Phase 2 |
What the finished NCT05239468 record still lists
NCT05239468 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 5 interventions - of which Bezafibrate 100 mg is the first listed.
NCT05239468 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05239468 about?
NCT05239468 is a clinical study titled "Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC". Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
What is the current status of trial NCT05239468?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2022-03-21. Estimated completion is 2025-09-01.
What interventions are being tested in trial NCT05239468?
The interventions under investigation include: Bezafibrate 100 mg (DRUG), Bezafibrate 200 mg (DRUG), Obeticholic Acid 5 mg (DRUG), Obeticholic Acid placebo (DRUG), Bezafibrate Placebo (DRUG).
Who is sponsoring clinical trial NCT05239468?
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 NCT05239468's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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