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NCT03323749 · ClinicalTrials.gov registry record · Phase 3
A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension
A Phase 3 study, sponsored by Stealth BioTherapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 218
- Enrollment target
NCT03323749: Clinical Trial Phase 3 study, sponsored by Stealth BioTherapeutics.
NCT03323749 is a Phase 3 study that was terminated before completion, run by Stealth BioTherapeutics. The registered enrollment target is 218 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03323749, a Phase 3 study, was terminated before completion, sponsored by Stealth BioTherapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 218 participants
- Enrollment target
Study Summary
This is a multicenter phase 3 randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety and efficacy of daily subcutaneous injections of elamipretide in subjects with primary mitochondrial myopathy. This will be followed by an open-label treatment extension.
Primary Outcome
Change From Baseline in Distance Walked (meters) on the Six-Minute Walk Test by Visit
Interventions
- COMBINATION_PRODUCT elamipretide
- COMBINATION_PRODUCT placebo comparator
- COMBINATION_PRODUCT elamipretide open label treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2017-10-09 |
| Est. Completion | 2020-02-10 |
| Phase | Phase 3 |
Why NCT03323749 stopped before completion
NCT03323749 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 3 interventions - of which elamipretide is the first listed.
NCT03323749 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03323749 about?
NCT03323749 is a clinical study titled "A Trial to Evaluate Safety and Efficacy of Elamipretide Primary Mitochondrial Myopathy Followed by Open-Label Extension". This is a multicenter phase 3 randomized, double-blind, parallel-group, placebo-controlled trial to evaluate the safety and efficacy of daily subcutaneous injections of elamipretide in subjects with primary mitochondrial myopathy. This will be followed by an open-label treatment extension.
What is the current status of trial NCT03323749?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2017-10-09. Estimated completion is 2020-02-10.
What interventions are being tested in trial NCT03323749?
The interventions under investigation include: elamipretide (COMBINATION_PRODUCT), placebo comparator (COMBINATION_PRODUCT), elamipretide open label treatment (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03323749?
This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03323749's enrollment target sits among peer trials
218 1331st of 2000 higher than 669 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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