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Study · Non-randomized trial · n = 24 · 2010

6 results

Influence of hepatic impairment on pharmacokinetics of the human GLP-1 analogue, liraglutide.

Flint A, Nazzal K, Jagielski P, Hindsberger C, Zdravkovic M

British journal of clinical pharmacology1 Dec 2010Cited by 56 (Europe PMC)

PMID21175436 (opens in a new tab)PMCIDPMC2997321 (opens in a new tab)DOI10.1111/j.1365-2125.2010.03762.x (opens in a new tab)PepBankPUB-21175436
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanNon-randomized trialPharmacokinetics

    In adults with hepatic impairment, liraglutide AUC was lowest in severe impairment (ratio to healthy 0.56) and equivalence across groups was not demonstrated.

    In plain wordsIn people with liver impairment, liraglutide exposure was not higher and was lowest in severe impairment compared with healthy people.

    Peptide
    Liraglutide
    Outcome
    DecreaseAUC(0,inf), severe hepatic impairment versus healthy
    Study

    n = 24

    Comparator
    Healthy subjects
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    AUC(0,inf) ratio severe/healthy
    0.56 ratio
    90% CI 0.39-0.81

    Source sentences

    Summary
    On the contrary, mean AUC(0,∞) was highest for healthy subjects and lowest for subjects with severe hepatic impairment (severe/healthy: 0.56, with 90% CI 0.39, 0.81) and equivalence in this parameter across groups was not demonstrated.
    2 context sentences
    Summary · context
    The primary endpoint was area under the plasma liraglutide concentration-time curve from time zero to infinity (AUC(0,∞)).
    Summary · context
    This parallel group, open label trial involved four groups of six subjects with healthy, mild, moderate and severe hepatic impairment, respectively. Each subject received 0.75 mg of liraglutide (s.c., thigh), and blood samples were taken over 72 h for PK assessment.
  2. 02HumanNon-randomized trialPharmacokinetics

    In adults with hepatic impairment, liraglutide Cmax tended to decrease with impairment (ratio severe to healthy 0.71).

    In plain wordsIn people with liver impairment, peak liraglutide levels tended to be lower than in healthy people.

    Peptide
    Liraglutide
    Outcome
    DecreaseCmax, severe hepatic impairment versus healthy
    Study

    n = 24

    Comparator
    Healthy subjects
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    Cmax ratio severe/healthy
    0.71 ratio
    90% CI 0.52-0.97

    Source sentences

    Summary
    C(max) also tended to decrease with hepatic impairment (severe/healthy: 0.71, with 90% CI 0.52, 0.97)
    1 context sentence
    Summary · context
    This parallel group, open label trial involved four groups of six subjects with healthy, mild, moderate and severe hepatic impairment, respectively. Each subject received 0.75 mg of liraglutide (s.c., thigh), and blood samples were taken over 72 h for PK assessment.
  3. 03HumanNon-randomized trialPharmacokinetics

    In adults with hepatic impairment, time to peak liraglutide level was similar across groups.

    In plain wordsTime to the peak liraglutide level was similar in people with and without liver impairment.

    Peptide
    Liraglutide
    Outcome
    No significant changetmax across hepatic function groups
    Study

    n = 24

    Comparator
    Healthy subjects
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    tmax
    11.3 to 13.2 h
    all groups

    Source sentences

    Summary
    but t(max) was similar across groups (11.3-13.2 h).
    1 context sentence
    Summary · context
    This parallel group, open label trial involved four groups of six subjects with healthy, mild, moderate and severe hepatic impairment, respectively. Each subject received 0.75 mg of liraglutide (s.c., thigh), and blood samples were taken over 72 h for PK assessment.
  4. 04HumanNon-randomized trialSafety outcome

    In adults with hepatic impairment and healthy subjects, no serious adverse events occurred after a single liraglutide dose.

    In plain wordsNo serious side effects occurred after one liraglutide dose in people with or without liver impairment.

    Peptide
    Liraglutide
    Outcome
    No significant changeSerious adverse events
    Study

    n = 24

    Comparator
    Healthy subjects
    Outcome group
    Adverse events · Liver
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    There were no serious adverse events, hypoglycaemic episodes or clinically significant changes in laboratory parameters and liraglutide was considered well tolerated.
    1 context sentence
    Summary · context
    This parallel group, open label trial involved four groups of six subjects with healthy, mild, moderate and severe hepatic impairment, respectively. Each subject received 0.75 mg of liraglutide (s.c., thigh), and blood samples were taken over 72 h for PK assessment.
  5. 05HumanNon-randomized trialSafety outcome

    In adults with hepatic impairment and healthy subjects, no hypoglycaemic episodes occurred after a single liraglutide dose.

    In plain wordsNo low blood sugar episodes occurred after one liraglutide dose in people with or without liver impairment.

    Peptide
    Liraglutide
    Outcome
    No significant changeHypoglycaemic episodes
    Study

    n = 24

    Comparator
    Healthy subjects
    Outcome group
    Adverse events · Liver
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    There were no serious adverse events, hypoglycaemic episodes or clinically significant changes in laboratory parameters and liraglutide was considered well tolerated.
    1 context sentence
    Summary · context
    This parallel group, open label trial involved four groups of six subjects with healthy, mild, moderate and severe hepatic impairment, respectively. Each subject received 0.75 mg of liraglutide (s.c., thigh), and blood samples were taken over 72 h for PK assessment.
  6. 06HumanNon-randomized trialSafety outcome

    In adults with hepatic impairment and healthy subjects, there were no clinically significant changes in laboratory parameters after a single liraglutide dose.

    In plain wordsNo clinically important lab changes occurred after one liraglutide dose in people with or without liver impairment.

    Peptide
    Liraglutide
    Outcome
    No significant changeLaboratory parameters
    Study

    n = 24

    Comparator
    Healthy subjects
    Outcome group
    Adverse events · Liver
    Studied dose
    0.75 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    There were no serious adverse events, hypoglycaemic episodes or clinically significant changes in laboratory parameters and liraglutide was considered well tolerated.
    1 context sentence
    Summary · context
    This parallel group, open label trial involved four groups of six subjects with healthy, mild, moderate and severe hepatic impairment, respectively. Each subject received 0.75 mg of liraglutide (s.c., thigh), and blood samples were taken over 72 h for PK assessment.

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

    12 Oct 2026, 12:10 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:05 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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