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NCT07531251 · ClinicalTrials.gov registry record · Phase 4
Clinical Trial in Patients With Barth Syndrome- 4TAZPower
A Phase 4 study, sponsored by Stealth BioTherapeutics.
- Not yet
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
NCT07531251 is a Phase 4 study that has not yet begun recruiting, run by Stealth BioTherapeutics. The registered enrollment target is 48 participants.
The verdict
NCT07531251, a Phase 4 study, has not yet begun recruiting, sponsored by Stealth BioTherapeutics.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
Study Summary
Phase 3b/4, randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the efficacy, safety, and pharmacokinetics of a once daily SC injection of elamipretide in subjects with genetically confirmed BTHS for 72 weeks. The primary trial objective is to confirm the efficacy of elamipretide which is approved in the United States(FORZINITY™) under the accelerated approval based on an improvement in knee extensor muscle strength, an intermediate clinical endpoint.
Interventions
- DRUG Placebo
- DRUG Elamipretide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2026-06-30 |
| Est. Completion | 2029-11-30 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07531251
The ClinicalTrials.gov registry entry for NCT07531251 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stealth BioTherapeutics, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07531251 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07531251 about?
NCT07531251 is a clinical study titled "Clinical Trial in Patients With Barth Syndrome- 4TAZPower". Phase 3b/4, randomized, double-blind, parallel-group, placebo-controlled clinical trial to evaluate the efficacy, safety, and pharmacokinetics of a once daily SC injection of elamipretide in subjects with genetically confirmed BTHS for 72 weeks. The primary trial objective is to confirm the efficacy...
What is the current status of trial NCT07531251?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2026-06-30. Estimated completion is 2029-11-30.
What interventions are being tested in trial NCT07531251?
The interventions under investigation include: Placebo (DRUG), Elamipretide (DRUG).
Who is sponsoring clinical trial NCT07531251?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
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