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Study · Randomized controlled trial · n = 48 · 2013

8 results

A single ascending-dose study of muscle regulator ACE-031 in healthy volunteers.

Attie KM, Borgstein NG, Yang Y, Condon CH, Wilson DM, Pearsall AE, Kumar R, Willins DA, Seehra JS, Sherman ML

Muscle & nerve21 Nov 2012Cited by 146 (Europe PMC)

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 study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In healthy postmenopausal women, single-dose ACE‑031 was generally well tolerated.

    In plain wordsIn healthy postmenopausal women, a single ACE‑031 dose was generally well tolerated.

    Outcome
    Direction not reportedOverall tolerability
    Study

    n = 48

    Outcome group
    Adverse events · Whole body
    Studied dose
    0.02-3 mg/kg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    ACE-031 was generally well-tolerated.
    1 context sentence
    Summary · context
    This double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ACE-031 in 48 healthy, postmenopausal women randomized to receive 1 dose of ACE-031 (0.02-3 mg/kg s.c.) or placebo (3:1).
  2. 02HumanRandomized controlled trialSafety outcome

    In healthy postmenopausal women receiving ACE‑031, adverse events included injection site erythema.

    In plain wordsIn healthy postmenopausal women, adverse events with ACE‑031 included redness at the injection site.

    Outcome
    Direction not reportedInjection site erythema
    Study

    n: not reported in source

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    0.02-3 mg/kg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Adverse events included injection site erythema.
    1 context sentence
    Summary · context
    This double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ACE-031 in 48 healthy, postmenopausal women randomized to receive 1 dose of ACE-031 (0.02-3 mg/kg s.c.) or placebo (3:1).
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy postmenopausal women, mean ACE‑031 AUC increased linearly with dose.

    In plain wordsIn healthy postmenopausal women, total ACE‑031 exposure increased linearly with dose.

    Outcome
    IncreaseAUC dose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.02-3 mg/kg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Mean ACE-031 AUC(0-∞) and C(max) increased linearly with dose; mean T(½) was 10-15 days.
    1 context sentence
    Summary · context
    This double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ACE-031 in 48 healthy, postmenopausal women randomized to receive 1 dose of ACE-031 (0.02-3 mg/kg s.c.) or placebo (3:1).
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy postmenopausal women, mean ACE‑031 Cmax increased linearly with dose.

    In plain wordsIn healthy postmenopausal women, peak ACE‑031 levels increased linearly with dose.

    Outcome
    IncreaseCmax dose proportionality
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.02-3 mg/kg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Mean ACE-031 AUC(0-∞) and C(max) increased linearly with dose; mean T(½) was 10-15 days.
    1 context sentence
    Summary · context
    This double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ACE-031 in 48 healthy, postmenopausal women randomized to receive 1 dose of ACE-031 (0.02-3 mg/kg s.c.) or placebo (3:1).
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy postmenopausal women, mean ACE‑031 half-life was 10-15 days.

    In plain wordsIn healthy postmenopausal women, the mean ACE‑031 half-life was 10-15 days.

    Outcome
    Not applicableElimination half-life
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.02-3 mg/kg · subcutaneousAs given in this study (human).

    Measurements

    Half-life
    10 to 15 days
    mean

    Source sentences

    Summary
    Mean ACE-031 AUC(0-∞) and C(max) increased linearly with dose; mean T(½) was 10-15 days.
    1 context sentence
    Summary · context
    This double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ACE-031 in 48 healthy, postmenopausal women randomized to receive 1 dose of ACE-031 (0.02-3 mg/kg s.c.) or placebo (3:1).
  6. 06HumanRandomized controlled trialEfficacy outcome

    In healthy postmenopausal women, ACE‑031 increased mean total body lean mass by 3.3% at day 29 (P = 0.03).

    In plain wordsIn healthy postmenopausal women, ACE‑031 increased lean body mass at day 29.

    Outcome
    IncreaseTotal body lean mass at day 29
    Study

    n: not reported in source

    Outcome group
    Muscle injury and repair · Musculoskeletal
    Studied dose
    3 mg/kg · subcutaneousAs given in this study (human).

    Measurements

    Lean mass increase
    3.3%
    3 mg/kg at day 29

    Source sentences

    Summary
    Statistically significant increases in mean total body lean mass (3.3%; P = 0.03, by DXA) and thigh muscle volume (5.1%; P = 0.03, by MRI) were observed at day 29 in the 3 mg/kg group.
    1 context sentence
    Summary · context
    This double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ACE-031 in 48 healthy, postmenopausal women randomized to receive 1 dose of ACE-031 (0.02-3 mg/kg s.c.) or placebo (3:1).
  7. 07HumanRandomized controlled trialEfficacy outcome

    In healthy postmenopausal women, ACE‑031 increased thigh muscle volume by 5.1% at day 29 (P = 0.03).

    In plain wordsIn healthy postmenopausal women, ACE‑031 increased thigh muscle volume at day 29.

    Outcome
    IncreaseThigh muscle volume at day 29
    Study

    n: not reported in source

    Outcome group
    Muscle injury and repair · Musculoskeletal
    Studied dose
    3 mg/kg · subcutaneousAs given in this study (human).

    Measurements

    Thigh muscle volume increase
    5.1%
    3 mg/kg at day 29

    Source sentences

    Summary
    Statistically significant increases in mean total body lean mass (3.3%; P = 0.03, by DXA) and thigh muscle volume (5.1%; P = 0.03, by MRI) were observed at day 29 in the 3 mg/kg group.
    1 context sentence
    Summary · context
    This double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ACE-031 in 48 healthy, postmenopausal women randomized to receive 1 dose of ACE-031 (0.02-3 mg/kg s.c.) or placebo (3:1).
  8. 08HumanRandomized controlled trialEfficacy outcome

    In healthy postmenopausal women, significant serum biomarker changes suggested that ACE‑031 also improved bone and fat metabolism.

    In plain wordsIn healthy postmenopausal women, blood marker changes suggested that ACE‑031 also improved bone and fat metabolism.

    Outcome
    Direction not reportedSerum biomarkers of bone and fat metabolism
    Study

    n: not reported in source

    Outcome group
    Bone and joint · Whole body
    Studied dose
    0.02-3 mg/kg · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Statistically significant changes in serum biomarkers suggest ACE-031 also improved bone and fat metabolism.
    1 context sentence
    Summary · context
    This double-blind, placebo-controlled study evaluated the safety, pharmacokinetics, and pharmacodynamics of ACE-031 in 48 healthy, postmenopausal women randomized to receive 1 dose of ACE-031 (0.02-3 mg/kg s.c.) or placebo (3:1).

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

    21 Oct 2026, 15:58 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 12:50 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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