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Study · Randomized controlled trial · n = 15 · 2022

7 results

Pharmacokinetics of Glepaglutide, A Long-Acting Glucagon-Like Peptide-2 Analogue: A Study in Healthy Subjects.

Agersnap MA, Sonne K, Knudsen KM, Knudsen CB, Berner-Hansen M

Clinical drug investigation2 Nov 2022Cited by 12 (Europe PMC)

PMID36323988 (opens in a new tab)PMCIDPMC9705454 (opens in a new tab)DOI10.1007/s40261-022-01210-1 (opens in a new tab)PepBankPUB-36323988
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, mean effective glepaglutide half-life was 124 h with 5 mg dosing (95% confidence interval 73-185 h).

    In plain wordsIn healthy subjects, mean effective glepaglutide half-life was 124 h with 5 mg dosing.

    Peptide
    Glepaglutide
    Outcome
    Not applicableEffective half-life
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 mg once weekly · subcutaneous · 6 weeksAs given in this study (human).

    Measurements

    Effective half-life
    124 h
    5 mg

    Source sentences

    Summary
    The estimated mean (95% confidence interval) effective half-life for glepaglutide 5 and 10 mg was 124 (73-185) h and 88 (31-146) h, respectively.
    2 context sentences
    Summary · context
    In this open-label, partially randomised, parallel-group study, healthy subjects were evenly randomised to glepaglutide 5 or 10 mg dosed subcutaneously once weekly for 6 weeks or to a single intravenous infusion of glepaglutide 1 mg.
    Summary · context
    Each group comprised 15 subjects.
  2. 02HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, mean effective glepaglutide half-life was 88 h with 10 mg dosing (95% confidence interval 31-146 h).

    In plain wordsIn healthy subjects, mean effective glepaglutide half-life was 88 h with 10 mg dosing.

    Peptide
    Glepaglutide
    Outcome
    Not applicableEffective half-life
    Study

    n = 15

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    10 mg once weekly · subcutaneous · 6 weeksAs given in this study (human).

    Measurements

    Effective half-life
    88 h
    10 mg

    Source sentences

    Summary
    The estimated mean (95% confidence interval) effective half-life for glepaglutide 5 and 10 mg was 124 (73-185) h and 88 (31-146) h, respectively.
    2 context sentences
    Summary · context
    In this open-label, partially randomised, parallel-group study, healthy subjects were evenly randomised to glepaglutide 5 or 10 mg dosed subcutaneously once weekly for 6 weeks or to a single intravenous infusion of glepaglutide 1 mg.
    Summary · context
    Each group comprised 15 subjects.
  3. 03HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, glepaglutide pharmacokinetics after subcutaneous dosing primarily reflected slow release of its two main metabolites from a subcutaneous depot.

    In plain wordsIn healthy subjects, comparison with intravenous dosing indicated that slow metabolite release mainly determined glepaglutide levels after subcutaneous dosing.

    Peptide
    Glepaglutide
    Outcome
    Not applicableDeterminants of subcutaneous pharmacokinetics
    Study

    n: not reported in source

    Comparator
    Intravenous glepaglutide 1 mg
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 or 10 mg once weekly · subcutaneous · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    From a comparison of pharmacokinetic parameters following subcutaneous versus intravenous dosing, it is concluded that the pharmacokinetics of glepaglutide following subcutaneous dosing are primarily determined by slow release of the two main glepaglutide metabolites from a subcutaneous depot.
    2 context sentences
    Summary · context
    In this open-label, partially randomised, parallel-group study, healthy subjects were evenly randomised to glepaglutide 5 or 10 mg dosed subcutaneously once weekly for 6 weeks or to a single intravenous infusion of glepaglutide 1 mg.
    Summary · context
    Each group comprised 15 subjects.
  4. 04HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, the two main metabolites accounted for >98% of glepaglutide exposure at steady state after weekly subcutaneous dosing.

    In plain wordsIn healthy subjects, two main metabolites accounted for >98% of glepaglutide exposure at steady state after weekly subcutaneous dosing.

    Peptide
    Glepaglutide
    Outcome
    Not applicableMetabolite share of steady-state exposure
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 or 10 mg once weekly · subcutaneous · 6 weeksAs given in this study (human).

    Measurements

    Metabolite share of overall glepaglutide exposure at steady state
    > 98%
    two main metabolites, once-weekly subcutaneous dosing

    Source sentences

    Summary
    For subcutaneous dosing once weekly, the two main metabolites accounted for >98% of the overall glepaglutide exposure at steady state, with the parent drug contributing to less than 1% of exposure.
    2 context sentences
    Summary · context
    In this open-label, partially randomised, parallel-group study, healthy subjects were evenly randomised to glepaglutide 5 or 10 mg dosed subcutaneously once weekly for 6 weeks or to a single intravenous infusion of glepaglutide 1 mg.
    Summary · context
    Each group comprised 15 subjects.
  5. 05HumanRandomized controlled trialPharmacokinetics

    In healthy subjects, the parent drug contributed less than 1% of glepaglutide exposure at steady state after weekly subcutaneous dosing.

    In plain wordsIn healthy subjects, the parent drug contributed less than 1% of glepaglutide exposure at steady state after weekly subcutaneous dosing.

    Peptide
    Glepaglutide
    Outcome
    Not applicableParent drug share of exposure
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 or 10 mg once weekly · subcutaneous · 6 weeksAs given in this study (human).

    Measurements

    Parent drug share of overall glepaglutide exposure at steady state
    < 1%
    parent drug, once-weekly subcutaneous dosing

    Source sentences

    Summary
    For subcutaneous dosing once weekly, the two main metabolites accounted for >98% of the overall glepaglutide exposure at steady state, with the parent drug contributing to less than 1% of exposure.
    2 context sentences
    Summary · context
    In this open-label, partially randomised, parallel-group study, healthy subjects were evenly randomised to glepaglutide 5 or 10 mg dosed subcutaneously once weekly for 6 weeks or to a single intravenous infusion of glepaglutide 1 mg.
    Summary · context
    Each group comprised 15 subjects.
  6. 06HumanRandomized controlled trialActivity measurement

    In healthy subjects, citrulline concentration increased at both subcutaneous glepaglutide dose levels.

    In plain wordsIn healthy subjects, citrulline concentration increased at both subcutaneous glepaglutide dose levels.

    Peptide
    Glepaglutide
    Outcome
    IncreaseCitrulline concentration
    Study

    n: not reported in source

    Outcome group
    Intestinal growth and absorption · Gastrointestinal
    Studied dose
    5 and 10 mg once weekly · subcutaneous · 6 weeksAs given in this study (human).

    Source sentences

    Summary
    There was an increase in the citrulline concentration for both glepaglutide subcutaneous dose levels.
    2 context sentences
    Summary · context
    In this open-label, partially randomised, parallel-group study, healthy subjects were evenly randomised to glepaglutide 5 or 10 mg dosed subcutaneously once weekly for 6 weeks or to a single intravenous infusion of glepaglutide 1 mg.
    Summary · context
    Each group comprised 15 subjects.
  7. 07HumanRandomized controlled trialSafety outcome

    In healthy subjects, the study identified no safety issues during glepaglutide treatment.

    In plain wordsIn healthy subjects, the study identified no safety issues during glepaglutide treatment.

    Peptide
    Glepaglutide
    Outcome
    Not applicableSafety issues
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    No safety issues were identified.
    2 context sentences
    Summary · context
    In this open-label, partially randomised, parallel-group study, healthy subjects were evenly randomised to glepaglutide 5 or 10 mg dosed subcutaneously once weekly for 6 weeks or to a single intravenous infusion of glepaglutide 1 mg.
    Summary · context
    Each group comprised 15 subjects.

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 1NCT03279302

Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects

Zealand Pharman = 754 Sept 2017 to 18 Dec 2017

Healthy Subjects

Trial pageClinicalTrials.govUpdated 22 Dec 2017

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

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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