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NCT05308472 · ClinicalTrials.gov registry record · Phase 2
Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP
A Phase 2 study, sponsored by Disc Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 75
- Enrollment target
NCT05308472: Completed Phase 2 study, sponsored by Disc Medicine.
NCT05308472 is a Phase 2 study that has completed, run by Disc Medicine. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05308472, a Phase 2 study, has completed, sponsored by Disc Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a Phase 2, multi-center, double-blind, placebo-controlled, parallel group study of bitopertin to evaluate the safety, tolerability, efficacy, and PPIX concentration change in participants with EPP. Participants may roll over to an open label extension portion after completing the double-blind treatment period.
Primary Outcome
Percent change from baseline in PPIX concentration was analyzed using a mixed model repeated measures analysis in the ITT population.
Interventions
- DRUG Placebo
- DRUG DISC-1459
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2022-10-31 |
| Est. Completion | 2024-08-23 |
| Phase | Phase 2 |
What the finished NCT05308472 record still lists
NCT05308472 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05308472 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05308472 about?
NCT05308472 is a clinical study titled "Study of Bitopertin to Evaluate the Safety, Tolerability, Efficacy, and PPIX Concentrations in Participants With EPP". This is a Phase 2, multi-center, double-blind, placebo-controlled, parallel group study of bitopertin to evaluate the safety, tolerability, efficacy, and PPIX concentration change in participants with EPP. Participants may roll over to an open label extension portion after completing the double-blin...
What is the current status of trial NCT05308472?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2022-10-31. Estimated completion is 2024-08-23.
What interventions are being tested in trial NCT05308472?
The interventions under investigation include: Placebo (DRUG), DISC-1459 (DRUG).
Who is sponsoring clinical trial NCT05308472?
This trial is sponsored by Disc Medicine, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05308472's enrollment target sits among peer trials
75 900th of 2000 higher than 1,081 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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