Human study PLS-00115

Effects of Elamipretide on Left Ventricular Function in Patients With Heart Failure With Reduced Ejection Fraction: The PROGRESS-HF Phase 2 Trial.

Randomized controlled trial · 71 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.

Effects of Elamipretide on Left Ventricular Function in Patients With Heart Failure With Reduced Ejection Fraction: The PROGRESS-HF Phase 2 Trial.primary · Journal of cardiac failure · 2020-02-14 · PMID 32068002 · DOI

Design and participants

Design: Randomized controlled trial
Population: Patients with stable heart failure with reduced ejection fraction (LVEF at or below 40%). Mean age 65 years, 24% female, mean EF 31%.
Conditions: Heart failure with reduced ejection fraction
Planned enrollment (registry): Not reported
Enrolled: 71
Randomized: 71
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 lower dose (intervention) · elamipretide · Elamipretide, lower of two doses, given subcutaneously once daily · subcutaneous · once daily for 28 consecutive days · Not reported assigned
Elamipretide higher dose (intervention) · elamipretide · Elamipretide, higher of two doses, given subcutaneously once daily · subcutaneous · once daily for 28 consecutive days · Not reported assigned
Placebo (comparator) · Placebo · placebo · subcutaneous · once daily for 28 consecutive days · Not reported assigned

What the authors reported

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

Change in left ventricular end systolic volume (LVESV)

primary outcome · surrogate · Baseline to week 4 · Cardiac magnetic resonance imaging

Elamipretide lower dose: change from baseline -4.4
Elamipretide higher dose: change from baseline -1.2
Placebo: change from baseline -3.8
Elamipretide lower dose vs Placebo: mean difference -0.3 (95% CI -4.6 to 4), p = 0.9 — Change in LVESV did not differ significantly from placebo
Elamipretide higher dose vs Placebo: mean difference 2.3 (95% CI -1.9 to 6.5), p = 0.28 — Change in LVESV did not differ significantly from placebo

Change in left ventricular ejection fraction (LVEF)

secondary outcome · surrogate · Week 4 · Cardiac imaging; method not specified for this outcome in the abstract

Elamipretide lower dose vs Placebo: narrative — No significant difference in change in LVEF versus placebo
Elamipretide higher dose vs Placebo: narrative — No significant difference in change in LVEF versus placebo

Study drug-related adverse events

secondary outcome · safety · Over 28-day treatment period · Rates of any study drug-related adverse events

Elamipretide lower dose vs Placebo: narrative — Rates of drug-related adverse events similar to placebo
Elamipretide higher dose vs Placebo: narrative — Rates of drug-related adverse events similar to placebo

Adverse events

Any study drug-related adverse event: Not reported participants

Monitoring: Adverse events were recorded. Only a statement that drug-related adverse event rates were similar across groups is reported in the abstract.

The authors concluded (paraphrased): Elamipretide was well tolerated but did not improve LVESV at 4 weeks compared with placebo in patients with stable HFrEF.

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 abstract is available. Methods, attrition, allocation details and full safety data cannot be verified.
short follow up: Treatment and assessment lasted only 28 days, too short to judge longer-term effects or safety.
inappropriate endpoint: Efficacy outcomes were imaging surrogates (LVESV, LVEF), not patient-important clinical outcomes.
small or imprecise: Only 71 patients were split across three arms, which limits precision, especially for adverse events.
selective reporting: Adverse events are reported only as similar rates of drug-related events, without counts or specific terms.

Change in left ventricular end systolic volume (LVESV): 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	Randomization 1:1:1 is stated, but sequence generation and allocation concealment are not described in the abstract.
Deviations from intended interventions	Some concerns	The trial was double-blind and placebo-controlled, but adherence and analysis population are not reported.
Missing outcome data	Some concerns	The numbers completing and analyzed per arm are not reported in the abstract.
Measurement of the outcome	Some concerns	Cardiac MRI is an objective measure and the trial was double-blind, but blinding of image readers is not explicitly stated.
Selection of the reported result	Some concerns	The prespecified analysis plan is not available, and no registry record is provided in the record.

The trial was randomized and double-blind, but the abstract-only report leaves several domains unverifiable.

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.

Change in left ventricular ejection fraction (LVEF): 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	Randomization is stated, but sequence generation and concealment details are absent from the abstract.
Deviations from intended interventions	Some concerns	The trial was double-blind, but adherence and analysis approach are not described in the abstract.
Missing outcome data	Some concerns	Attrition and the number analyzed for LVEF are not reported.
Measurement of the outcome	Some concerns	The method of LVEF assessment and assessor blinding are not explicitly described for this outcome.
Selection of the reported result	Some concerns	LVEF is reported only narratively as not significant, with no estimates given in the abstract.

This is a randomized blinded design, but limited abstract reporting and a narrative-only result raise some concerns.

Study drug-related adverse events: 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	Randomization is stated without details of sequence generation or allocation concealment.
Deviations from intended interventions	Some concerns	Double-blind placebo control is stated, but deviations and adherence are not reported.
Missing outcome data	Some concerns	The number of participants in the safety analysis per arm is not given in the abstract.
Measurement of the outcome	Some concerns	Attribution of events as drug-related is subjective, and the ascertainment method is not described.
Selection of the reported result	Some concerns	Only a summary statement of similar rates is given, without counts, terms or serious events.

The safety result is reported only narratively in the abstract, with unclear ascertainment and no counts.

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”, indirect evidence

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

Where each value comes from

adverse_events: PMID 32068002, abstract (Results, sentence 4) · extracted by AI (automated, not verified by a person) · abstract only
arms: PMID 32068002, abstract (Methods, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
author_conclusion: PMID 32068002, abstract (Conclusions, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
design: PMID 32068002, abstract (Methods, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
limitations: PMID 32068002, abstract (Methods and Results) · extracted by AI (automated, not verified by a person) · abstract only
outcomes: PMID 32068002, abstract (Background sentence 2; Results sentences 2-3) · extracted by AI (automated, not verified by a person) · abstract only
participants: PMID 32068002, abstract (Methods, sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
population: PMID 32068002, abstract (Methods sentence 1; Results sentence 1) · extracted by AI (automated, not verified by a person) · abstract only
results: PMID 32068002, abstract (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).