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NCT02976038 · ClinicalTrials.gov registry record · Phase 2

Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)

A Phase 2 study, sponsored by Stealth BioTherapeutics.

Terminated
Registry status
Phase 2
Development phase
28
Enrollment target

NCT02976038: Clinical Trial Phase 2 study, sponsored by Stealth BioTherapeutics.

NCT02976038 is a Phase 2 study that was terminated before completion, run by Stealth BioTherapeutics. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02976038, a Phase 2 study, was terminated before completion, sponsored by Stealth BioTherapeutics.

TERMINATED
Registry status
Phase 2
Development phase
28 participants
Enrollment target

Study Summary

This is a Phase 2 Open-Label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed Primary Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial

Primary Outcome

Change From Baseline in Distance Walked (meters) on the Six-Minute Walk Test by Visit

Interventions

  • DRUG elamipretide

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2016-12
Est. Completion 2020-04-09
Phase Phase 2
Stealth BioTherapeutics

23 total trials

Why NCT02976038 stopped before completion

NCT02976038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).

The record links to 0 conditions, and to 1 intervention - of which elamipretide is the first listed.

NCT02976038 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02976038 about?

NCT02976038 is a clinical study titled "Open-Label Extension Trial to Characterize the Long-term Safety and Tolerability of Elamipretide in Subjects With Genetically Confirmed Primary Mitochondrial Myopathy (PMM)". This is a Phase 2 Open-Label extension study to evaluate the long term safety and tolerability of daily elamipretide injections in patients with genetically confirmed Primary Mitochondrial Disease who previously participated in the SPIMM-202 Clinical Trial

What is the current status of trial NCT02976038?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2016-12. Estimated completion is 2020-04-09.

What interventions are being tested in trial NCT02976038?

The interventions under investigation include: elamipretide (DRUG).

Who is sponsoring clinical trial NCT02976038?

This trial is sponsored by Stealth BioTherapeutics, which has 23 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02976038's enrollment target sits among peer trials

28 1677th of 2000 higher than 304 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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Source: ClinicalTrials.gov NCT02976038, the US trial registry maintained by the National Library of Medicine. NCT02976038 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.