Human study PLS-00222

Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy

Other design · 36 participants enrolled

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

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).