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Study · Non-randomized trial · n = 16 · 2026

3 results

Pharmacokinetics and Safety of Single-Dose Apraglutide in Individuals with Normal and Impaired Hepatic Function: A Phase 1, Open-Label Trial.

Greig G, Hay J, Valencia P, Boules M, Masior T

Clinical pharmacology in drug development1 Jan 2026

PMID41545784 (opens in a new tab)PMCIDPMC12811208 (opens in a new tab)DOI10.1002/cpdd.70006 (opens in a new tab)PepBankPUB-41545784
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Summary

Intestinal failure-associated liver disease occurs in 20% to 30% of patients with short bowel syndrome and intestinal failure (SBS-IF). Apraglutide is a glucagon-like peptide-2 (GLP-2) analog in clinical development for the treatment of patients with SBS-IF. This study assessed the potential for changes in exposure of apraglutide in individuals with impaired hepatic function versus healthy volunteers. In this Phase 1, open-label, nonrandomized, single-dose trial, apraglutide 3.5 mg was administered to participants with moderate hepatic impairment (Child-Pugh B) or normal hepatic function. Primary pharmacokinetic endpoints were area under the plasma concentration-time curve (AUC) from time 0 to infinity (AUCinf) or AUC from time 0 to last quantifiable concentration (AUClast) if AUCinf could not be reliably estimated, AUC0-168 h, and maximum observed plasma concentration (Cmax). Secondary endpoints included safety and tolerability. Each group comprised eight participants. No increased apraglutide exposure was observed in individuals with moderate hepatic impairment. A lower Cmax and AUCinf of apraglutide was observed in individuals with moderate hepatic impairment versus those with normal hepatic function (Cmax = 58.7 vs 71.3 ng/mL; AUCinf = 4086 vs 5351 h ng/mL, respectively). The respective geometric mean ratios were 0.835 and 0.936 for Cmax and AUCinf, and the upper bounds of their 90% confidence intervals indicate that participants with moderate hepatic impairment were not overexposed to apraglutide versus those with normal hepatic function. Adverse events were mild or moderate in severity. The results of this trial suggest that apraglutide does not require dose alteration in patients with mild and moderate hepatic impairment.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study3

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

  1. 01HumanNon-randomized trialPharmacokinetics

    In moderate hepatic impairment, apraglutide maximum concentration was 58.7 versus 71.3 ng/mL with normal hepatic function.

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

    Peptide
    Apraglutide
    Outcome
    DecreaseMaximum plasma concentration
    Study

    n = 16

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

    Measurements

    Cmax
    58.7 ng/mL
    moderate hepatic impairment
    Cmax
    71.3 ng/mL
    normal hepatic function
    Geometric mean ratio of Cmax
    0.835 ratio
    moderate impairment vs normal

    Source sentences

    Summary
    A lower Cmax and AUCinf of apraglutide was observed in individuals with moderate hepatic impairment versus those with normal hepatic function (Cmax = 58.7 vs 71.3 ng/mL; AUCinf = 4086 vs 5351 h ng/mL, respectively).
    2 context sentences
    Summary · context
    The respective geometric mean ratios were 0.835 and 0.936 for Cmax and AUCinf, and the upper bounds of their 90% confidence intervals indicate that participants with moderate hepatic impairment were not overexposed to apraglutide versus those with normal hepatic function.
    Summary · context
    In this Phase 1, open-label, nonrandomized, single-dose trial, apraglutide 3.5 mg was administered to participants with moderate hepatic impairment (Child-Pugh B) or normal hepatic function.
  2. 02HumanNon-randomized trialPharmacokinetics

    In moderate hepatic impairment, apraglutide AUC to infinity was 4086 versus 5351 h ng/mL with normal hepatic function.

    In plain wordsIn participants with moderate liver impairment, apraglutide exposure was lower than with normal liver function.

    Peptide
    Apraglutide
    Outcome
    DecreaseAUC to infinity
    Study

    n = 16

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

    Measurements

    AUCinf
    4086 h ng/mL
    moderate hepatic impairment
    AUCinf
    5351 h ng/mL
    normal hepatic function
    Geometric mean ratio of AUCinf
    0.936 ratio
    moderate impairment vs normal

    Source sentences

    Summary
    A lower Cmax and AUCinf of apraglutide was observed in individuals with moderate hepatic impairment versus those with normal hepatic function (Cmax = 58.7 vs 71.3 ng/mL; AUCinf = 4086 vs 5351 h ng/mL, respectively).
    2 context sentences
    Summary · context
    The respective geometric mean ratios were 0.835 and 0.936 for Cmax and AUCinf, and the upper bounds of their 90% confidence intervals indicate that participants with moderate hepatic impairment were not overexposed to apraglutide versus those with normal hepatic function.
    Summary · context
    In this Phase 1, open-label, nonrandomized, single-dose trial, apraglutide 3.5 mg was administered to participants with moderate hepatic impairment (Child-Pugh B) or normal hepatic function.
  3. 03HumanNon-randomized trialSafety outcome

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

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

    Peptide
    Apraglutide
    Outcome
    Not applicableAdverse event severity
    Study

    n = 16

    Analysis
    Secondary
    Outcome group
    Adverse events · Whole body
    Studied dose
    3.5 mg · 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, nonrandomized, single-dose trial, apraglutide 3.5 mg was administered to participants with moderate hepatic impairment (Child-Pugh B) or normal hepatic function.

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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