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Study · Randomized controlled trial · n = 39 · 2021

4 results

In vivo mitochondrial ATP production is improved in older adult skeletal muscle after a single dose of elamipretide in a randomized trial.

Roshanravan B, Liu SZ, Ali AS, Shankland EG, Goss C, Amory JK, Robertson HT, Marcinek DJ, Conley KE

PloS one15 Jul 2021Cited by 32 (Europe PMC)

PMID34264994 (opens in a new tab)PMCIDPMC8282018 (opens in a new tab)DOI10.1371/journal.pone.0253849 (opens in a new tab)PepBankPUB-34264994
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Summary

BackgroundLoss of mitochondrial function contributes to fatigue, exercise intolerance and muscle weakness, and is a key factor in the disability that develops with age and a wide variety of chronic disorders. Here, we describe the impact of a first-in-class cardiolipin-binding compound that is targeted to mitochondria and improves oxidative phosphorylation capacity (Elamipretide, ELAM) in a randomized, double-blind, placebo-controlled clinical trial.MethodsNon-invasive magnetic resonance and optical spectroscopy provided measures of mitochondrial capacity (ATPmax) with exercise and mitochondrial coupling (ATP supply per O2 uptake; P/O) at rest. The first dorsal interosseous (FDI) muscle was studied in 39 healthy older adult subjects (60 to 85 yrs of age; 46% female) who were enrolled based on the presence of poorly functioning mitochondria. We measured volitional fatigue resistance by force-time integral over repetitive muscle contractions.ResultsA single ELAM dose elevated mitochondrial energetic capacity in vivo relative to placebo (ΔATPmax; P = 0.055, %ΔATPmax; P = 0.045) immediately after a 2-hour infusion. No difference was found on day 7 after treatment, which is consistent with the half-life of ELAM in human blood. No significant changes were found in resting muscle mitochondrial coupling. Despite the increase in ATPmax there was no significant effect of treatment on fatigue resistance in the FDI.ConclusionsThese results highlight that ELAM rapidly and reversibly elevates mitochondrial capacity after a single dose. This response represents the first demonstration of a pharmacological intervention that can reverse mitochondrial dysfunction in vivo immediately after treatment in aging human muscle.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In healthy older adults, a single elamipretide dose raised muscle mitochondrial capacity (ATPmax) versus placebo immediately after a 2-hour infusion.

    In plain wordsIn healthy older adults, one dose of elamipretide raised the energy-making capacity of muscle mitochondria more than placebo right after infusion.

    Peptide
    Elamipretide (SS-31)
    Outcome
    IncreaseMitochondrial energetic capacity (ATPmax) immediately after infusion
    Study

    n = 39

    Comparator
    Placebo
    Outcome group
    Mitochondrial function · Musculoskeletal
    Studied dose
    single dose · infusion · 2-hour infusionAs given in this study (human).

    Source sentences

    Summary
    A single ELAM dose elevated mitochondrial energetic capacity in vivo relative to placebo (ΔATPmax; P = 0.055, %ΔATPmax; P = 0.045) immediately after a 2-hour infusion.
    1 context sentence
    Summary · context
    The first dorsal interosseous (FDI) muscle was studied in 39 healthy older adult subjects (60 to 85 yrs of age; 46% female) who were enrolled based on the presence of poorly functioning mitochondria.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In healthy older adults, a single elamipretide dose caused no difference in muscle ATPmax versus placebo on day 7.

    In plain wordsIn healthy older adults, one dose of elamipretide no longer differed from placebo in muscle mitochondrial capacity a week later.

    Peptide
    Elamipretide (SS-31)
    Outcome
    No significant changeMitochondrial energetic capacity (ATPmax) on day 7
    Study

    n = 39

    Comparator
    Placebo
    Outcome group
    Mitochondrial function · Musculoskeletal
    Studied dose
    single dose · infusion · 2-hour infusionAs given in this study (human).

    Source sentences

    Summary
    No difference was found on day 7 after treatment, which is consistent with the half-life of ELAM in human blood.
    1 context sentence
    Summary · context
    The first dorsal interosseous (FDI) muscle was studied in 39 healthy older adult subjects (60 to 85 yrs of age; 46% female) who were enrolled based on the presence of poorly functioning mitochondria.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In healthy older adults, a single elamipretide dose caused no significant change in resting muscle mitochondrial coupling versus placebo.

    In plain wordsIn healthy older adults, one dose of elamipretide did not change resting muscle mitochondrial coupling compared with placebo.

    Peptide
    Elamipretide (SS-31)
    Outcome
    No significant changeResting muscle mitochondrial coupling (P/O)
    Study

    n = 39

    Comparator
    Placebo
    Outcome group
    Mitochondrial function · Musculoskeletal
    Studied dose
    single dose · infusion · 2-hour infusionAs given in this study (human).

    Source sentences

    Summary
    No significant changes were found in resting muscle mitochondrial coupling.
    1 context sentence
    Summary · context
    The first dorsal interosseous (FDI) muscle was studied in 39 healthy older adult subjects (60 to 85 yrs of age; 46% female) who were enrolled based on the presence of poorly functioning mitochondria.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In healthy older adults, a single elamipretide dose had no significant effect on fatigue resistance versus placebo.

    In plain wordsIn healthy older adults, one dose of elamipretide did not improve muscle fatigue resistance compared with placebo.

    Peptide
    Elamipretide (SS-31)
    Outcome
    No significant changeFatigue resistance in the first dorsal interosseous muscle
    Study

    n = 39

    Comparator
    Placebo
    Outcome group
    Exercise and physical function · Musculoskeletal
    Studied dose
    single dose · infusion · 2-hour infusionAs given in this study (human).

    Source sentences

    Summary
    Despite the increase in ATPmax there was no significant effect of treatment on fatigue resistance in the FDI.
    1 context sentence
    Summary · context
    The first dorsal interosseous (FDI) muscle was studied in 39 healthy older adult subjects (60 to 85 yrs of age; 46% female) who were enrolled based on the presence of poorly functioning mitochondria.

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

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.

  1. Version 2Current

    9 Oct 2026, 18:17 UTC

    Study results updated

  2. 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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