Human study PLS-00224

A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Function

Other design · 23 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.

A Phase 1 Study Investigating the Safety and Pharmacokinetics of Repeat-dose Intravenous Infusion of MTP-131 in Subjects With Impaired Renal Functionregistry entry · NCT02436447 (COMPLETED, no results posted, planned enrollment 23)

Design and participants

Design: Other design
Population: Subjects with impaired renal function (registered condition: normal and impaired renal function)
Conditions: Normal and impaired renal function
Planned enrollment (registry): 23
Enrolled: 23
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.

MTP-131 (intervention) · elamipretide · MTP-131 (elamipretide) given as a repeat-dose intravenous infusion. Grouping by renal function is not described in the record. · intravenous infusion · repeat-dose; duration not stated · Not reported assigned

What the authors reported

As stated in the sources. This is the authors’ account, not Peptide Library’s assessment.

Safety

unclear outcome · safety · Not described beyond the title's statement that safety was investigated

No results reported.

Pharmacokinetics

unclear outcome · surrogate · Not described beyond the title's statement that pharmacokinetics were investigated

No results reported.

Adverse events

None reported. That is not evidence of safety.

Monitoring: The title states the study investigated safety. Specific monitoring procedures are not described 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: Registry record only: the study is marked completed, but no results are posted and no publication is provided.
no control group: No placebo or untreated comparator is described; all registered interventions are MTP-131.
small or imprecise: Actual enrollment was only 23 participants, which limits the precision of any safety estimate.
inappropriate population: Participants had normal or impaired renal function, not Barth syndrome or primary mitochondrial myopathy.
inappropriate endpoint: The study's focus is safety and pharmacokinetics; no efficacy or patient-important functional outcomes are registered.

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 (wrong population) 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 NCT02436447, registry (interventions) · extracted by AI (automated, not verified by a person)
design: NCT NCT02436447, registry (phases, study_type) · extracted by AI (automated, not verified by a person)
limitations: NCT NCT02436447, registry (has_results, status) · extracted by AI (automated, not verified by a person)
outcomes: NCT NCT02436447, title (study title) · extracted by AI (automated, not verified by a person)
participants: NCT NCT02436447, registry (enrollment, enrollment_type) · extracted by AI (automated, not verified by a person)
population: NCT NCT02436447, registry (conditions) · 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).