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Study · Non-randomized trial · n = 33 · 2026

7 results

Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide.

Nielsen MJF, Becker NP, Duus HHH, Kirkeby K, Kupčová V, Lauenborg BW, Low B, Svolgaard O, Witten L

Clinical pharmacokinetics1 Jun 2026Cited by 1 (Europe PMC)

PMID42228334 (opens in a new tab)PMCIDPMC13356073 (opens in a new tab)DOI10.1007/s40262-026-01654-0 (opens in a new tab)PepBankPUB-42228334
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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. 01HumanNon-randomized trialPharmacokinetics

    In adults with mild, moderate or severe renal impairment, total cagrilintide exposure (AUC) after a single dose was similar to that with normal renal function.

    In plain wordsIn adults with kidney impairment, the body took in about the same amount of cagrilintide as in adults with normal kidney function.

    Peptide
    Cagrilintide
    Outcome
    No significant changeAUC0-inf in renal impairment
    Study

    n = 33

    Comparator
    Normal renal or hepatic function
    Analysis
    Primary
    Outcome group
    Pharmacokinetics · Kidney and urinary
    Studied dose
    0.6 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    AUC ratio vs normal function
    1.23 ratio
    mild renal impairment
    AUC ratio vs normal function
    1.18 ratio
    moderate renal impairment
    AUC ratio vs normal function
    1.21 ratio
    severe renal impairment

    Source sentences

    Summary
    Compared with normal renal function, the estimated ratio of the mean AUC0-∞ was 1.23 (90% confidence interval [CI], 0.91-1.66) in mild impairment, 1.18 (0.87-1.59) in moderate impairment and 1.21 (0.87-1.68) in severe impairment.
    2 context sentences
    Title · context
    Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide.
    Summary · context
    In both studies, adult participants were categorised into four groups on the basis of renal or hepatic function (normal function and mild, moderate or severe impairment) and received a single dose of cagrilintide 0.6 or 0.9 mg, respectively.
  2. 02HumanNon-randomized trialPharmacokinetics

    In adults with mild, moderate or severe hepatic impairment, total cagrilintide exposure (AUC) after a single dose was similar to that with normal hepatic function.

    In plain wordsIn adults with liver impairment, the body took in about the same amount of cagrilintide as in adults with normal liver function.

    Peptide
    Cagrilintide
    Outcome
    No significant changeAUC0-inf in hepatic impairment
    Study

    n = 32

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

    Measurements

    AUC ratio vs normal function
    0.99 ratio
    mild hepatic impairment
    AUC ratio vs normal function
    1.01 ratio
    moderate hepatic impairment
    AUC ratio vs normal function
    1.11 ratio
    severe hepatic impairment

    Source sentences

    Summary
    Compared with normal hepatic function, the estimated ratio of the mean AUC0-∞ was 0.99 (0.89-1.11) in mild impairment, 1.01 (0.91-1.12) in moderate impairment and 1.11 (0.96-1.30) in severe impairment.
    2 context sentences
    Title · context
    Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide.
    Summary · context
    In both studies, adult participants were categorised into four groups on the basis of renal or hepatic function (normal function and mild, moderate or severe impairment) and received a single dose of cagrilintide 0.6 or 0.9 mg, respectively.
  3. 03HumanNon-randomized trialPharmacokinetics

    In both studies, cagrilintide Cmax and other pharmacokinetic parameters were similar across groups, with no consistent pattern with renal or hepatic impairment.

    In plain wordsIn adults with kidney or liver impairment, peak cagrilintide levels and other measures were similar across groups.

    Peptide
    Cagrilintide
    Outcome
    No significant changeCmax and other pharmacokinetic parameters
    Study

    n: not reported in source

    Comparator
    Normal renal or hepatic function
    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    0.6 mg (renal study) or 0.9 mg (hepatic study) · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    In both studies, total cagrilintide exposure (AUC0-∞), Cmax and other pharmacokinetic parameters were similar across groups with no consistent patterns observed with renal or hepatic impairment.
    2 context sentences
    Title · context
    Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide.
    Summary · context
    In both studies, adult participants were categorised into four groups on the basis of renal or hepatic function (normal function and mild, moderate or severe impairment) and received a single dose of cagrilintide 0.6 or 0.9 mg, respectively.
  4. 04HumanNon-randomized trialSafety outcome

    In adults with renal or hepatic impairment, 21 and 16 treatment-emergent adverse events were reported after a single cagrilintide dose, with no increase as impairment increased.

    In plain wordsIn adults with kidney or liver impairment, side effects after one cagrilintide dose did not increase with more severe impairment.

    Peptide
    Cagrilintide
    Outcome
    No significant changeTreatment-emergent adverse events
    Study

    n: not reported in source

    Comparator
    Normal renal or hepatic function
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.6 mg (renal study) or 0.9 mg (hepatic study) · subcutaneous · single doseAs given in this study (human).

    Measurements

    Treatment-emergent adverse events, renal study
    21 events
    11 participants
    Treatment-emergent adverse events, hepatic study
    16 events
    9 participants

    Source sentences

    Summary
    Overall, 21 and 16 treatment-emergent adverse events (TEAEs) were reported in 11 and 9 participants in the renal and hepatic studies, respectively.
    2 context sentences
    Summary · context
    No increase in number of adverse events with increasing renal or hepatic impairment was observed, and no new safety or tolerability findings with cagrilintide were identified with renal or hepatic impairment.
    Summary · context
    In both studies, adult participants were categorised into four groups on the basis of renal or hepatic function (normal function and mild, moderate or severe impairment) and received a single dose of cagrilintide 0.6 or 0.9 mg, respectively.
  5. 05HumanNon-randomized trialSafety outcome

    In adults with renal or hepatic impairment, no serious treatment-emergent adverse events were reported after a single cagrilintide dose.

    In plain wordsIn adults with kidney or liver impairment, no serious side effects were reported after one cagrilintide dose.

    Peptide
    Cagrilintide
    Outcome
    No significant changeSerious treatment-emergent adverse events
    Study

    n: not reported in source

    Comparator
    Normal renal or hepatic function
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.6 mg (renal study) or 0.9 mg (hepatic study) · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    In both studies, no serious TEAEs, TEAEs leading to study withdrawal or deaths were reported.
    1 context sentence
    Summary · context
    In both studies, adult participants were categorised into four groups on the basis of renal or hepatic function (normal function and mild, moderate or severe impairment) and received a single dose of cagrilintide 0.6 or 0.9 mg, respectively.
  6. 06HumanNon-randomized trialSafety outcome

    In adults with renal or hepatic impairment, no treatment-emergent adverse events led to study withdrawal after a single cagrilintide dose.

    In plain wordsIn adults with kidney or liver impairment, no one left the study because of side effects after one cagrilintide dose.

    Peptide
    Cagrilintide
    Outcome
    No significant changeWithdrawal due to treatment-emergent adverse events
    Study

    n: not reported in source

    Comparator
    Normal renal or hepatic function
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.6 mg (renal study) or 0.9 mg (hepatic study) · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    In both studies, no serious TEAEs, TEAEs leading to study withdrawal or deaths were reported.
    1 context sentence
    Summary · context
    In both studies, adult participants were categorised into four groups on the basis of renal or hepatic function (normal function and mild, moderate or severe impairment) and received a single dose of cagrilintide 0.6 or 0.9 mg, respectively.
  7. 07HumanNon-randomized trialSafety outcome

    In adults with renal or hepatic impairment, no deaths were reported after a single cagrilintide dose.

    In plain wordsIn adults with kidney or liver impairment, no deaths were reported after one cagrilintide dose.

    Peptide
    Cagrilintide
    Outcome
    No significant changeDeaths
    Study

    n: not reported in source

    Comparator
    Normal renal or hepatic function
    Outcome group
    Mortality · Whole body
    Studied dose
    0.6 mg (renal study) or 0.9 mg (hepatic study) · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    In both studies, no serious TEAEs, TEAEs leading to study withdrawal or deaths were reported.
    1 context sentence
    Summary · context
    In both studies, adult participants were categorised into four groups on the basis of renal or hepatic function (normal function and mild, moderate or severe impairment) and received a single dose of cagrilintide 0.6 or 0.9 mg, respectively.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 1NCT05564104

A Research Study Looking at How a Single Dose of the Medicine Cagrilintide Works in Participants With Reduced Liver Function and in Healthy Participants With Normal Liver Function and How Cagrilintide is Absorbed and Used by the Body

Novo Nordisk A/Sn = 325 Apr 2023 to 19 Dec 2024

Hepatic Impairment · Healthy Volunteers

Trial pageClinicalTrials.govUpdated 12 Dec 2025
CompletedPhase 1NCT04209049

A Research Study Looking Into Blood Levels of NNC0174-0833 in People With Normal and Impaired Kidney Function

Novo Nordisk A/Sn = 3315 Jan 2020 to 5 Jan 2021

Overweight · Obesity

Trial pageClinicalTrials.govUpdated 26 Jan 2021

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. Versions 3 to 38Current

    28 Oct 2026, 02:04 UTC

    The same notice was added 36 times, first on 9 Oct 2026, 18:17 UTC. The status did not change between them.

    Study results updated

  2. Version 2

    9 Oct 2026, 03:06 UTC

    Study data updated · source update from Europe PMC

  3. Version 1

    9 Oct 2026, 03:04 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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