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NCT05162768 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)
A Phase 3 study, sponsored by Stealth BioTherapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 102
- Enrollment target
NCT05162768: Completed Phase 3 study, sponsored by Stealth BioTherapeutics.
NCT05162768 is a Phase 3 study that has completed, run by Stealth BioTherapeutics. The registered enrollment target is 102 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05162768, a Phase 3 study, has completed, sponsored by Stealth BioTherapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 102 participants
- Enrollment target
Study Summary
SPIMD-301 is a 48-week, randomized, double-blind, parallel-group, placebo-controlled trial to assess efficacy and safety of single daily subcutaneous (SC) administration of elamipretide as a treatment for subjects with primary mitochondrial myopathy associated with nuclear DNA mutations (nPMD).
Primary Outcome
Change from Baseline in Distance Walked (in meters) on the Six-Minute Walk Test by Visit
Interventions
- DRUG Placebo
- DRUG Elamipretide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2022-04-29 |
| Est. Completion | 2024-12-04 |
| Phase | Phase 3 |
What the finished NCT05162768 record still lists
NCT05162768 is an interventional study that assigns participants to a tested intervention. The registered 102 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 (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05162768 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05162768 about?
NCT05162768 is a clinical study titled "Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)". SPIMD-301 is a 48-week, randomized, double-blind, parallel-group, placebo-controlled trial to assess efficacy and safety of single daily subcutaneous (SC) administration of elamipretide as a treatment for subjects with primary mitochondrial myopathy associated with nuclear DNA mutations (nPMD).
What is the current status of trial NCT05162768?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 102 participants. The study started on 2022-04-29. Estimated completion is 2024-12-04.
What interventions are being tested in trial NCT05162768?
The interventions under investigation include: Placebo (DRUG), Elamipretide (DRUG).
Who is sponsoring clinical trial NCT05162768?
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 NCT05162768's enrollment target sits among peer trials
102 1676th of 2000 higher than 321 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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