Human study PLS-00222
Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy
Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
Reports of this study
Every publication, registration and abstract describing this one study. Participants are counted once.
- Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathyregistry entry · NCT02367014 (COMPLETED, results posted, planned enrollment 36)
Design and participants
- Design
- Other design
- Population
- People with mitochondrial myopathy. Age and other eligibility details are not stated in the record.
- Conditions
- Mitochondrial Myopathy
- Planned enrollment (registry)
- 36
- Enrolled
- 36
- Randomized
- Not reported
- Completed follow-up
- Not reported
Intervention and comparator
What each group received. Related peptides, analogs and combinations are never treated as the compound itself.
- Elamipretide low dose (intervention) · elamipretide · Elamipretide (MTP-131), low-dose group as listed in the registry interventions · Not reported assigned
- Elamipretide intermediate dose (intervention) · elamipretide · Elamipretide (MTP-131), intermediate-dose group as listed in the registry interventions · Not reported assigned
- Elamipretide high dose (intervention) · elamipretide · Elamipretide (MTP-131), high-dose group as listed in the registry interventions · Not reported assigned
- Placebo (comparator) · Placebo · placebo · Not reported assigned
What the authors reported
As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.
Adverse events
None reported. That is not evidence of safety.
Monitoring: The title states that safety and tolerability were assessed. No specific monitoring procedures are given in the record.
Peptide Library’s assessment
An automated assessment, made by AI separately from the authors’ conclusions and not reviewed by a person. How risk of bias is assessed.
Limitations
- other: Only the registry entry is available. No outcome measures, results or adverse event data appear in the record despite has_results being true.
- small or imprecise: Actual enrollment was 36 participants spread across three elamipretide dose groups and a placebo group, so any estimate would be imprecise.
- inadequate randomization: The record does not state whether or how participants were randomized or whether allocation was concealed.
- inadequate blinding: A placebo arm is listed, but masking of participants and assessors is not described in the record.
- selective reporting: Registered outcome measures are not given in the record, so results cannot be checked against prespecified outcomes.
- abstract only: No publication or abstract is available in the record; only registry fields are available.
No risk-of-bias assessment has been published for this study’s results.
Claims this study informs
- Improves function in Barth syndrome: not eligible (wrong population) for “Muscle strength, exercise capacity and fatigue”
- Improves exercise capacity in primary mitochondrial myopathy: not eligible (insufficient data) for “Six-minute walk distance and fatigue”
- Is safe for human administration: not eligible (insufficient data) for “Adverse events, including injection-site reactions, and discontinuations”
Where each value comes from
- arms: NCT NCT02367014, registry (interventions field) · extracted by AI (automated, not verified by a person)
- design: NCT NCT02367014, registry (phases, study_type and interventions fields) · extracted by AI (automated, not verified by a person)
- outcomes: NCT NCT02367014, title (study title (safety, tolerability, efficacy)) · extracted by AI (automated, not verified by a person)
- participants: NCT NCT02367014, registry (enrollment and enrollment_type fields) · extracted by AI (automated, not verified by a person)
- population: NCT NCT02367014, registry (conditions field) · extracted by AI (automated, not verified by a person)
Version 1 · published November 8, 2026 · evidence through November 8, 2026 · research snapshot 2026.1.1 · methodology ev-1 · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.
These assessments describe published research. Records marked automated were produced by AI under the published methodology and have not been reviewed by a person; they can contain errors. None of this is medical advice, not a statement about any product’s safety for human use, and not a regulatory approval. Peptide Library’s vendor and partner relationships play no part in them (editorial independence).