Human study PLS-00117

EMBRACE STEMI study: a Phase 2a trial to evaluate the safety, tolerability, and efficacy of intravenous MTP-131 on reperfusion injury in patients undergoing primary percutaneous coronary intervention.

Randomized controlled trial · Not reported participants enrolled

Version 1 · published November 7, 2026 · evidence through November 7, 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.

Only the abstract was available. Essential methods may be missing, which limits what can be judged.

Reports of this study

Every publication, registration and abstract describing this one study. Participants are counted once.

EMBRACE STEMI study: a Phase 2a trial to evaluate the safety, tolerability, and efficacy of intravenous MTP-131 on reperfusion injury in patients undergoing primary percutaneous coronary intervention.primary · European heart journal · 2015-11-19 · PMID 26586786 · DOI

Design and participants

Design: Randomized controlled trial
Population: Adults with first-time anterior ST-elevation myocardial infarction due to a proximal or mid left anterior descending artery occlusion who were undergoing primary percutaneous coronary intervention.
Conditions: ST-elevation myocardial infarction, Myocardial reperfusion injury
Setting: Multicentre trial in patients undergoing primary percutaneous coronary intervention; the abstract does not name the centres.
Planned enrollment (registry): Not reported
Enrolled: Not reported
Randomized: Not reported
Completed follow-up: Not reported
Funding: Not stated in the record.
Authors’ conflicts: Not stated in the record.

Intervention and comparator

What each group received. Related peptides, analogs and combinations are never treated as the compound itself.

MTP-131 (elamipretide) (intervention) · elamipretide · MTP-131, a cell-permeable peptide (development code for elamipretide), given as an intravenous infusion around primary PCI · intravenous infusion · single 1-hour infusion · Not reported assigned
Placebo (comparator) · Placebo infusion · placebo · intravenous infusion · single 1-hour infusion · Not reported assigned

What the authors reported

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

Infarct size by CK-MB area under the curve over 72 h

primary outcome · surrogate · 0-72 hours · Creatine kinase-myocardial band area under the curve (ng h/mL)

Placebo: mean 5785 — CK-MB AUC reported as 5785 ± 426 ng h/mL in the placebo group
MTP-131 (elamipretide): mean 5570 — CK-MB AUC reported as 5570 ± 486 ng h/mL in the MTP-131 group
MTP-131 (elamipretide) vs Placebo: narrative — No significant reduction with MTP-131 versus placebo (P reported as NS)

Pre-specified MRI, angiographic and electrocardiographic outcomes

secondary outcome · surrogate · Cardiac magnetic resonance imaging, coronary angiographic and electrocardiographic measures (specific measures not given in the abstract)

MTP-131 (elamipretide) vs Placebo: narrative — MTP-131 was not associated with improvement in pre-specified MRI, angiographic or ECG outcomes

Clinical outcomes

secondary outcome · patient-important · Pre-specified clinical outcomes (not specified in the abstract)

MTP-131 (elamipretide) vs Placebo: narrative — MTP-131 was not associated with improvement in pre-specified clinical outcomes

Safety and tolerability

unclear outcome · safety · Safety and tolerability (methods not described in the abstract)

MTP-131 (elamipretide) vs Placebo: narrative — Authors state MTP-131 administration was safe and well tolerated

Adverse events

None reported. That is not evidence of safety.

Monitoring: The trial evaluated safety and tolerability, but the abstract does not describe the monitoring methods or the adverse event data.

The authors concluded (paraphrased): In first-time anterior STEMI with proximal or mid LAD lesions treated with successful PCI, MTP-131 was safe and well tolerated. It did not reduce infarct size measured by CK-MB AUC over 72 h.

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

abstract only: Only the PubMed abstract is available, so details of methods, sample size, attrition and adverse events cannot be checked.
inappropriate endpoint: The primary endpoint is a biomarker surrogate (CK-MB AUC) rather than a clinical event or symptom outcome.
small or imprecise: This is a Phase 2a trial and the abstract reports no sample size, no confidence intervals and only 'P = NS'.
selective reporting: Secondary MRI, angiographic, ECG and clinical outcomes are summarized only narratively, without numerical results.
short follow up: The primary endpoint covers only 72 hours, and the duration of clinical follow-up is not reported in the abstract.
inappropriate population: The acute STEMI population differs from the mitochondrial disease populations targeted by some of the claims.

Infarct size by CK-MB area under the curve over 72 h: Some concerns (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	The abstract says the trial was randomized but gives no details of sequence generation, allocation concealment or baseline balance.
Deviations from intended interventions	Some concerns	The trial is described as double-blind, but the abstract gives no information on adherence or on the analysis population.
Missing outcome data	Some concerns	Numbers randomized and analysed are not reported in the abstract, so missing outcome data cannot be assessed.
Measurement of the outcome	Low risk of bias	CK-MB is an objective laboratory measure in a double-blind trial, so it is unlikely to be influenced by knowledge of assignment.
Selection of the reported result	Some concerns	CK-MB AUC is named as the primary endpoint, but there is no registry record or protocol to confirm the pre-specified analysis.

Reporting is limited to the abstract, with unclear randomization, missing-data handling and pre-specification, although the outcome measure is objective.

Version 1 · published November 7, 2026 · evidence through November 7, 2026 · research snapshot 2026.1.1 · methodology ev-1 · RoB 2 (2019-08-22) · Automated assessment by AI (claude-opus-5-5 and claude-sonnet-5-5), not reviewed by a person.

Pre-specified MRI, angiographic and electrocardiographic outcomes: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	Randomization is stated, but the abstract gives no details of the method or allocation concealment.
Deviations from intended interventions	Some concerns	The trial is double-blind, but the abstract gives no information on deviations from the intended intervention or on the analysis set.
Missing outcome data	Some concerns	The abstract does not report how many participants had imaging or ECG data, and MRI completion is often incomplete.
Measurement of the outcome	Some concerns	Imaging and ECG readings involve interpretation; blinded core-lab assessment is not described in the abstract.
Selection of the reported result	High risk of bias	Results are given only as a narrative 'no improvement' statement, with no specific measures or numbers reported.

Narrative-only reporting of several outcomes, with no numerical results and unclear missing data, raises a high risk of bias in the reported result.

Clinical outcomes: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	The abstract states the trial was randomized but gives no details on how allocation was generated or concealed.
Deviations from intended interventions	Some concerns	Blinding is stated, but adherence and the analysis population are not described in the abstract.
Missing outcome data	Some concerns	Follow-up completeness for clinical outcomes is not reported anywhere in the abstract.
Measurement of the outcome	Some concerns	The clinical outcomes and how they were adjudicated are not specified in the abstract.
Selection of the reported result	High risk of bias	Clinical outcomes are reported only as 'no improvement', without naming the outcomes or giving data.

The clinical outcomes are unspecified and summarized only narratively, so the risk of bias in the reported result is high.

Safety and tolerability: High risk of bias (Cochrane RoB 2)

Risk of bias in one result of a randomized trial, judged in five domains.

Domain judgments
Randomization process	Some concerns	Randomization is stated in the abstract without details of sequence generation or concealment.
Deviations from intended interventions	Some concerns	The trial is double-blind, but the abstract does not describe the safety population or protocol deviations.
Missing outcome data	Some concerns	The abstract reports no counts of participants treated or followed for safety.
Measurement of the outcome	Some concerns	Methods for collecting and grading adverse events are not described in the abstract.
Selection of the reported result	High risk of bias	Safety is summarized only as 'safe and well tolerated', with no adverse event data by arm.

Safety is reported only as a narrative author statement, without event counts, so selective or incomplete reporting cannot be excluded.

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: eligible for “Adverse events, including injection-site reactions, and discontinuations”, direct evidence

Insufficient information to assess Adverse events, including injection-site reactions, and discontinuations

Where each value comes from

adverse_events: PMID 26586786, abstract (Conclusion, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
arms: PMID 26586786, abstract (Methods and results, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 26586786, abstract (Conclusion, sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 26586786, abstract (Methods and results, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
limitations: PMID 26586786, abstract (Methods and results, sentences 1-3) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 26586786, abstract (Methods and results, sentences 2-3) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 26586786, abstract (Methods and results, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 26586786, abstract (Methods and results, sentences 2-3) · extracted by AI (automated, not verified by a person) · abstract only

Version 1 · published November 7, 2026 · evidence through November 7, 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).