# Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)

> **NCT05162768** · PHASE3 · COMPLETED · sponsor: **Stealth BioTherapeutics Inc.** · enrollment: 102 (actual)

## Conditions studied

- Mitochondrial Myopathies
- Mitochondrial Pathology
- Mitochondrial DNA Mutation
- Mitochondrial Diseases
- Mitochondrial DNA Deletion
- Mitochondrial DNA Depletion
- Mitochondrial Metabolism Defect
- Mitochondrial Complex I Deficiency

## Interventions

- **DRUG:** Elamipretide
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT05162768
- **Lead sponsor:** Stealth BioTherapeutics Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2022-04-29
- **Primary completion:** 2024-09-30
- **Final completion:** 2024-12-04
- **Target enrollment:** 102 (ACTUAL)
- **Last updated:** 2025-10-24


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05162768

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05162768, "Study to Evaluate Efficacy and Safety of Elamipretide in Subjects With Primary Mitochondrial Disease From Nuclear DNA Mutations (nPMD)". Retrieved via AI Analytics 2026-07-19 from https://api.ai-analytics.org/clinical/NCT05162768. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*