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Study · Non-randomized trial · n = 16 · 2024

3 results

Pharmacokinetics and Tolerability of a Single Dose of Apraglutide, a Novel, Long-Acting, Synthetic glucagon-like peptide-2 Analog With a Unique Pharmacologic Profile, in Individuals With Impaired Renal Function.

Greig G, Youssef NN, Bolognani F

Journal of clinical pharmacology11 Mar 2024Cited by 5 (Europe PMC)

PMID38465515 (opens in a new tab)DOI10.1002/jcph.2423 (opens in a new tab)PepBankPUB-38465515
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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 study3

3 results from studies that gave the peptide. 3 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In severe renal impairment, apraglutide maximum concentration was 36.9 versus 59.5 ng/L with normal renal function.

    In plain wordsIn participants with severe kidney impairment, peak apraglutide concentrations were lower than with normal kidney function.

    Peptide
    Apraglutide
    Outcome
    DecreaseMaximum plasma concentration
    Study

    n = 16

    Comparator
    normal renal function
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    Cmax
    36.9 ng/L
    severe renal impairment
    Cmax
    59.5 ng/L
    normal renal function
    Geometric mean ratio of Cmax
    0.62 ratio
    severe renal impairment vs normal renal function

    Source sentences

    Summary
    Apraglutide achieved a lower Cmax and AUCinf in individuals with severe renal impairment versus those with normal renal function (Cmax = 36.9 vs 59.5 ng/L; AUCinf = 3100 vs 4470 h · ng/mL, respectively).
    2 context sentences
    Summary · context
    The respective geometric mean ratios were 0.620 and 0.693 for Cmax and AUCinf, and the upper bound of their 90% confidence intervals were <2, indicating patients with severe renal impairment were not overexposed to apraglutide versus those with normal renal function.
    Summary · context
    In this phase 1, open-label, multicenter, nonrandomized, parallel-group study, a single dose of apraglutide 5 mg was administered subcutaneously
  2. 02HumanNon-randomized trialPharmacokinetics

    In severe renal impairment, apraglutide AUC to infinity was 3100 versus 4470 h · ng/mL with normal renal function.

    In plain wordsIn participants with severe kidney impairment, apraglutide exposure was lower than with normal kidney function.

    Peptide
    Apraglutide
    Outcome
    DecreaseAUC to infinity
    Study

    n = 16

    Comparator
    normal renal function
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    5 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    AUCinf
    3100 h · ng/mL
    severe renal impairment
    AUCinf
    4470 h · ng/mL
    normal renal function
    Geometric mean ratio of AUCinf
    0.693 ratio
    severe renal impairment vs normal renal function

    Source sentences

    Summary
    Apraglutide achieved a lower Cmax and AUCinf in individuals with severe renal impairment versus those with normal renal function (Cmax = 36.9 vs 59.5 ng/L; AUCinf = 3100 vs 4470 h · ng/mL, respectively).
    2 context sentences
    Summary · context
    The respective geometric mean ratios were 0.620 and 0.693 for Cmax and AUCinf, and the upper bound of their 90% confidence intervals were <2, indicating patients with severe renal impairment were not overexposed to apraglutide versus those with normal renal function.
    Summary · context
    In this phase 1, open-label, multicenter, nonrandomized, parallel-group study, a single dose of apraglutide 5 mg was administered subcutaneously
  3. 03HumanNon-randomized trialSafety outcome

    In the apraglutide renal-function trial, adverse events were mild or moderate.

    In plain wordsIn the apraglutide kidney-function trial, adverse events were mild or moderate.

    Peptide
    Apraglutide
    Outcome
    Not applicableAdverse event severity
    Study

    n = 16

    Outcome group
    Adverse events · Whole body
    Studied dose
    5 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Adverse events were mild or moderate in severity.
    1 context sentence
    Summary · context
    In this phase 1, open-label, multicenter, nonrandomized, parallel-group study, a single dose of apraglutide 5 mg was administered subcutaneously

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

    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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