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Study · Non-randomized trial · n = 44 · 2018

3 results

Pharmacokinetics and tolerability of semaglutide in people with hepatic impairment.

Jensen L, Kupcova V, Arold G, Pettersson J, Hjerpsted JB

Diabetes, obesity & metabolism17 Jan 2018Cited by 58 (Europe PMC)

PMID29205786 (opens in a new tab)PMCIDPMC5873441 (opens in a new tab)DOI10.1111/dom.13186 (opens in a new tab)PepBankPUB-29205786
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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-ND. 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 people with mild, moderate or severe hepatic impairment, semaglutide AUC0-inf after a single dose was similar to that in people with normal hepatic function.

    In plain wordsHepatic impairment did not change how much semaglutide stayed in the blood after one dose, compared with normal liver function.

    Peptide
    Semaglutide
    Outcome
    No significant changeSemaglutide AUC0-inf by hepatic function
    Study

    n = 44

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

    Measurements

    AUC0-inf treatment ratio
    0.95 ratio
    mild impairment/normal function
    AUC0-inf treatment ratio
    1.02 ratio
    moderate impairment/normal function
    AUC0-inf treatment ratio
    0.97 ratio
    severe impairment/normal function

    Source sentences

    Summary
    Semaglutide exposure was similar across all groups, with AUC0-∞ treatment ratios for mild impairment/normal function of 0.95 (90% CI 0.77, 1.16), moderate impairment/normal function 1.02 (90% CI 0.93, 1.12), and severe impairment/normal function 0.97 (90% CI 0.84, 1.12).
    2 context sentences
    Summary · context
    No effect of hepatic impairment was declared if the 90% confidence interval (CI) for the between-group ratio (hepatic impairment/normal function) was within the interval 0.70 to 1.43.
    Summary · context
    In this multicentre, open-label, parallel-group trial (sponsor Novo Nordisk, ClinicalTrials.gov ID NCT02210871), four groups of participants with normal hepatic function (n = 19) or mild (n = 8), moderate (n = 10) or severe (n = 7) hepatic impairment received a single, subcutaneous dose of 0.5 mg semaglutide.
  2. 02HumanNon-randomized trialPharmacokinetics

    In people with hepatic impairment, maximum semaglutide plasma concentration after a single dose did not appear to differ from that in people with normal hepatic function.

    In plain wordsHepatic impairment did not appear to change the peak semaglutide level in the blood, compared with normal liver function.

    Peptide
    Semaglutide
    Outcome
    No significant changeSemaglutide Cmax by hepatic function
    Study

    n = 44

    Comparator
    Normal hepatic function
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.5 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    Cmax treatment ratio
    0.99 ratio
    mild impairment/normal function
    Cmax treatment ratio
    1.02 ratio
    moderate impairment/normal function
    Cmax treatment ratio
    1.15 ratio
    severe impairment/normal function

    Source sentences

    Summary
    The maximum plasma semaglutide concentration (Cmax ) did not appear to be influenced by hepatic function, with mild impairment/normal function treatment ratios of 0.99 (90% CI 0.80, 1.23), moderate impairment/normal function 1.02 (90% CI 0.88, 1.18) and severe impairment/normal function 1…
    1 context sentence
    Summary · context
    In this multicentre, open-label, parallel-group trial (sponsor Novo Nordisk, ClinicalTrials.gov ID NCT02210871), four groups of participants with normal hepatic function (n = 19) or mild (n = 8), moderate (n = 10) or severe (n = 7) hepatic impairment received a single, subcutaneous dose of 0.5 mg semaglutide.
  3. 03HumanNon-randomized trialSafety outcome

    After a single 0.5 mg semaglutide dose, 10 participants reported 12 mild or moderate non-serious adverse events, and no unexpected safety issues were seen.

    In plain wordsAfter one dose, 10 people reported mild or moderate side effects that were not serious, and no unexpected safety problems appeared.

    Peptide
    Semaglutide
    Outcome
    Not applicableAdverse events after a single semaglutide dose
    Study

    n = 44

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

    Source sentences

    Summary
    In all, 10 participants reported 12 mild or moderate non-serious adverse events. No unexpected safety or tolerability issues were observed.
    1 context sentence
    Summary · context
    In this multicentre, open-label, parallel-group trial (sponsor Novo Nordisk, ClinicalTrials.gov ID NCT02210871), four groups of participants with normal hepatic function (n = 19) or mild (n = 8), moderate (n = 10) or severe (n = 7) hepatic impairment received a single, subcutaneous dose of 0.5 mg semaglutide.

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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 1NCT02210871

Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Novo Nordisk A/Sn = 447 Aug 2014 to 3 Jun 2015

Diabetes · Diabetes Mellitus, Type 2 · Hepatic Impaired

Trial pageClinicalTrials.govUpdated 21 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

    11 Oct 2026, 00:50 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:06 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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