Human study PLS-00123

The mitochondria-targeting peptide elamipretide diminishes circulating HtrA2 in ST-segment elevation myocardial infarction.

Randomized controlled trial · 35 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.

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.

The mitochondria-targeting peptide elamipretide diminishes circulating HtrA2 in ST-segment elevation myocardial infarction.primary · European heart journal. Acute cardiovascular care · 2017-05-23 · PMID 28534645 · DOI

Design and participants

Design: Randomized controlled trial
Population: Patients with first-time acute anterior ST-segment elevation myocardial infarction after percutaneous coronary intervention (n=19, a subset of the EMBRACE trial), plus a reference group of healthy blood donors (n=16).
Conditions: ST-segment elevation myocardial infarction, Myocardial ischaemia-reperfusion injury
Setting: Multicenter phase 2a clinical study (EMBRACE) in acute STEMI after percutaneous coronary intervention.
Planned enrollment (registry): Not reported
Enrolled: 35
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.

STEMI + elamipretide (intervention) · elamipretide · Mitochondria-targeting peptide elamipretide given within the EMBRACE phase 2a study · 10 assigned
STEMI without elamipretide (comparator) · STEMI patients from EMBRACE who did not receive elamipretide; the comparator treatment is not described in the abstract · other · 9 assigned
Healthy donors (comparator) · Healthy blood donors used as a reference group; not part of the trial · other · 16 assigned

What the authors reported

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

Serum HtrA2 level

post hoc outcome · surrogate · After percutaneous coronary intervention (exact timing not stated) · Serum high-temperature requirement serine peptidase 2 (HtrA2) measured by ELISA in peripheral blood

STEMI without elamipretide vs Healthy donors: median 1805.5 — Median serum HtrA2 was significantly higher in STEMI patients than in healthy controls; the range given in parentheses is not defined as a confidence interval.
Healthy donors: median 392.4 — Median serum HtrA2 in healthy controls.
STEMI + elamipretide vs STEMI without elamipretide: median 496.5 — Elamipretide significantly reduced median serum HtrA2 after myocardial infarction compared with STEMI patients not given elamipretide.

Adverse events

None reported. That is not evidence of safety.

Monitoring: Not reported in the abstract.

The authors concluded (paraphrased): Serum HtrA2 is raised in STEMI and was lower in patients given elamipretide. HtrA2 may be a biomarker of mitochondrial-induced cardiomyocyte apoptosis and ischaemia-reperfusion injury, which needs validation in a larger trial.

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

small or imprecise: Only 19 STEMI patients (10 elamipretide, 9 without) were analysed, so estimates are very imprecise.
inappropriate endpoint: The only human outcome is a serum biomarker (HtrA2), with no clinical or patient-important outcomes reported.
selection bias: How this subset of 19 patients was selected from the EMBRACE trial is not described, so randomization balance may not hold.
selective reporting: This is an exploratory biomarker analysis; the abstract gives no prespecified analysis plan and reports only p<=0.05 thresholds.
abstract only: Only the abstract is available, so the comparator, dosing, timing and blinding details are not reported.
inappropriate population: The STEMI population is unrelated to the Barth syndrome or mitochondrial myopathy claims being assessed.
other: The abstract mixes human and mouse results. The group comparisons are not clearly described and the median figures are ambiguously ordered.

Serum HtrA2 level: 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	Publication type lists RCT (EMBRACE), but this analysis uses an undescribed subset of 19 patients; randomization and concealment are not reported.
Deviations from intended interventions	High risk of bias	The abstract gives no information on blinding or deviations from assigned intervention.
Missing outcome data	Some concerns	Only 19 trial patients had samples analysed, and the reasons for including this subset are not given.
Measurement of the outcome	Some concerns	An objective ELISA assay was used, but assessor blinding and sampling timing are not reported in the abstract.
Selection of the reported result	High risk of bias	This is a post hoc exploratory biomarker analysis without a stated prespecified plan; results are reported only as P<=0.05.

The reported-result domain is high risk, and the other domains raise concerns because the subset selection and trial conduct are undescribed in the abstract.

Version 1 · published November 8, 2026 · evidence through November 8, 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.

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 (wrong outcome) for “Adverse events, including injection-site reactions, and discontinuations”

Where each value comes from

arms: PMID 28534645, abstract (Methods, sentences 2-3) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 28534645, abstract (Conclusion, sentences 1-6) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 28534645, abstract (Methods, sentence 2 (EMBRACE phase 2a); publication types) · extracted by AI (automated, not verified by a person) · abstract only
limitations: PMID 28534645, abstract (Conclusion, final sentence) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 28534645, abstract (Methods, sentence 4) · extracted by AI (automated, not verified by a person) · abstract only
participants: PMID 28534645, abstract (Methods, sentences 1-3) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 28534645, abstract (Methods, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 28534645, abstract (Results, sentences 1-2) · extracted by AI (automated, not verified by a person) · abstract only

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).