Novel Mitochondria-Targeting Peptide in Heart Failure Treatment: A Randomized, Placebo-Controlled Trial of Elamipretide.

Daubert MA, Yow E, Dunn G, Marchev S, Barnhart H, Douglas PS, O'Connor C, Goldstein S, Udelson JE, Sabbah HN

Circulation. Heart failure1 Dec 2017Cited by 147 (Europe PMC)

PMID29217757DOI10.1161/circheartfailure.117.004389PepBankPUB-29217757

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialSafety outcome
In patients with heart failure with reduced ejection fraction, no serious adverse events were reported after a single elamipretide infusion.
In plain wordsIn people with heart failure, no serious side effects were reported after a single elamipretide infusion.
Peptide
Elamipretide (SS-31)
Outcome
No significant changeSerious adverse events
Study
n = 36
Comparator
Placebo
Outcome group
Adverse events · Whole body
Studied dose
0.005, 0.05 and 0.25 mg/kg/h · infusion · single 4-hour infusionAs given in this study (human).
Source sentences
Summary
There were no serious adverse events.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, ascending-dose trial, patients with heart failure with reduced ejection fraction (ejection fraction, ≤35%) were randomized to either a single 4-hour infusion of elamipretide (cohort 1 [n=8], 0.005; cohort 2 [n=8], 0.05; and cohort 3 [n=8], 0.25 mg·kg-1<…
Report a problemFND-2921775702
02HumanRandomized controlled trialSafety outcome
In patients with heart failure with reduced ejection fraction, blood pressure remained stable in all elamipretide cohorts.
In plain wordsIn people with heart failure, blood pressure stayed stable in all elamipretide dose groups.
Peptide
Elamipretide (SS-31)
Outcome
No significant changeBlood pressure
Study
n = 36
Comparator
Placebo
Outcome group
Blood pressure · Cardiovascular
Studied dose
0.005, 0.05 and 0.25 mg/kg/h · infusion · single 4-hour infusionAs given in this study (human).
Source sentences
Summary
Blood pressure and heart rate remained stable in all cohorts.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, ascending-dose trial, patients with heart failure with reduced ejection fraction (ejection fraction, ≤35%) were randomized to either a single 4-hour infusion of elamipretide (cohort 1 [n=8], 0.005; cohort 2 [n=8], 0.05; and cohort 3 [n=8], 0.25 mg·kg-1<…
Report a problemFND-2921775703
03HumanRandomized controlled trialSafety outcome
In patients with heart failure with reduced ejection fraction, heart rate remained stable in all elamipretide cohorts.
In plain wordsIn people with heart failure, heart rate stayed stable in all elamipretide dose groups.
Peptide
Elamipretide (SS-31)
Outcome
No significant changeHeart rate
Study
n = 36
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
0.005, 0.05 and 0.25 mg/kg/h · infusion · single 4-hour infusionAs given in this study (human).
Source sentences
Summary
Blood pressure and heart rate remained stable in all cohorts.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, ascending-dose trial, patients with heart failure with reduced ejection fraction (ejection fraction, ≤35%) were randomized to either a single 4-hour infusion of elamipretide (cohort 1 [n=8], 0.005; cohort 2 [n=8], 0.05; and cohort 3 [n=8], 0.25 mg·kg-1<…
Report a problemFND-2921775704
04HumanRandomized controlled trialPharmacokinetics
In patients with heart failure with reduced ejection fraction, peak plasma concentrations of elamipretide occurred at end-infusion and were undetectable by 24 hours after infusion.
In plain wordsIn people with heart failure, elamipretide blood levels peaked at the end of the infusion and could not be detected 24 hours later.
Peptide
Elamipretide (SS-31)
Outcome
Not applicablePlasma concentration time course
Study
n = 24
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
0.005, 0.05 and 0.25 mg/kg/h · infusion · single 4-hour infusionAs given in this study (human).
Source sentences
Summary
Peak plasma concentrations of elamipretide occurred at end-infusion and were undetectable by 24 hours postinfusion.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, ascending-dose trial, patients with heart failure with reduced ejection fraction (ejection fraction, ≤35%) were randomized to either a single 4-hour infusion of elamipretide (cohort 1 [n=8], 0.005; cohort 2 [n=8], 0.05; and cohort 3 [n=8], 0.25 mg·kg-1<…
Report a problemFND-2921775701
05HumanRandomized controlled trialEfficacy outcome
In patients with heart failure with reduced ejection fraction, the highest elamipretide dose decreased left ventricular end-diastolic volume compared with placebo at end infusion.
In plain wordsIn people with heart failure, the highest elamipretide dose lowered the heart's relaxed-state volume more than placebo at the end of the infusion.
Peptide
Elamipretide (SS-31)
Outcome
DecreaseLeft ventricular end-diastolic volume at end infusion
Study
n = 20
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
0.25 mg/kg/h · infusion · single 4-hour infusionAs given in this study (human).
Measurements
Change in LV end-diastolic volume
−18 mL
highest dose cohort vs placebo
Source sentences
Summary
Compared with placebo, a significant decrease in left ventricular end-diastolic volume (-18 mL; P=0.009)
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, ascending-dose trial, patients with heart failure with reduced ejection fraction (ejection fraction, ≤35%) were randomized to either a single 4-hour infusion of elamipretide (cohort 1 [n=8], 0.005; cohort 2 [n=8], 0.05; and cohort 3 [n=8], 0.25 mg·kg-1<…
Report a problemFND-2921775705
06HumanRandomized controlled trialEfficacy outcome
In patients with heart failure with reduced ejection fraction, the highest elamipretide dose decreased left ventricular end-systolic volume compared with placebo at end infusion.
In plain wordsIn people with heart failure, the highest elamipretide dose lowered the heart's squeezed-state volume more than placebo at the end of the infusion.
Peptide
Elamipretide (SS-31)
Outcome
DecreaseLeft ventricular end-systolic volume at end infusion
Study
n = 20
Comparator
Placebo
Outcome group
Heart function · Cardiovascular
Studied dose
0.25 mg/kg/h · infusion · single 4-hour infusionAs given in this study (human).
Measurements
Change in LV end-systolic volume
−14 mL
highest dose cohort vs placebo
Source sentences
Summary
Compared with placebo, a significant decrease in left ventricular end-diastolic volume (-18 mL; P=0.009) and end-systolic volume (-14 mL; P=0.005) occurred at end infusion in the highest dose cohort.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled, ascending-dose trial, patients with heart failure with reduced ejection fraction (ejection fraction, ≤35%) were randomized to either a single 4-hour infusion of elamipretide (cohort 1 [n=8], 0.005; cohort 2 [n=8], 0.05; and cohort 3 [n=8], 0.25 mg·kg-1<…
Report a problemFND-2921775706

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT02388464

A Study Investigating the Safety, Tolerability, and Pharmacokinetics of MTP-131 in Subjects With Congestive Heart Failure

Stealth BioTherapeutics Inc.n = 36Jul 2014 to Jun 2015

Congestive Heart Failure

Trial page ClinicalTrials.govUpdated 17 Sept 2015

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
9 Oct 2026, 18:17 UTC
Study results updated
Version 1
9 Oct 2026, 02:47 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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