Skip to content

Study · Non-randomized trial · n = 56 · 2017

7 results

Pharmacokinetics and Tolerability of a Single Dose of Semaglutide, a Human Glucagon-Like Peptide-1 Analog, in Subjects With and Without Renal Impairment.

Marbury TC, Flint A, Jacobsen JB, Derving Karsbøl J, Lasseter K

Clinical pharmacokinetics1 Nov 2017Cited by 102 (Europe PMC)

PMID28349386 (opens in a new tab)PMCIDPMC5648736 (opens in a new tab)DOI10.1007/s40262-017-0528-2 (opens in a new tab)PepBankPUB-28349386
Read at sourcePubMedAsk about this study
Jump to 7 results

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 subjects with mild or moderate renal impairment or ESRD, semaglutide exposure after a single 0.5 mg dose was similar to that in subjects with normal renal function.

    In plain wordsIn people with mild or moderate kidney impairment or kidney failure, semaglutide levels were similar to those with normal kidney function.

    Peptide
    Semaglutide
    Outcome
    No significant changeSemaglutide exposure in mild or moderate renal impairment and ESRD
    Study

    n = 56

    Comparator
    Subjects with normal renal function
    Outcome group
    Pharmacokinetics · Kidney and urinary
    Studied dose
    0.5 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Semaglutide exposure in subjects with mild/moderate RI and ESRD was similar to that in subjects with normal renal function.
    2 context sentences
    Summary · context
    Fifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg.
    Summary · context
    Semaglutide plasma concentrations were assessed ≤480 h post-dose; the primary endpoint was the area under the plasma concentration-time curve from time zero to infinity.
  2. 02HumanNon-randomized trialPharmacokinetics

    In subjects with severe renal impairment, mean semaglutide exposure was 22% higher than in subjects with normal renal function, and the confidence interval exceeded the pre-specified limits.

    In plain wordsIn people with severe kidney impairment, semaglutide levels were 22% higher than with normal kidney function.

    Peptide
    Semaglutide
    Outcome
    IncreaseSemaglutide exposure in severe renal impairment
    Study

    n = 56

    Comparator
    Subjects with normal renal function
    Outcome group
    Pharmacokinetics · Kidney and urinary
    Studied dose
    0.5 mg · subcutaneous · single doseAs given in this study (human).

    Measurements

    Exposure ratio CI
    1.02 to 1.47 ratio
    severe RI vs normal

    Source sentences

    Summary
    In subjects with severe RI, the mean exposure of semaglutide was 22% higher than in subjects with normal renal function, and the 95% confidence interval (1.02-1.47) for the ratio exceeded the pre-specified limits (0.70-1.43).
    2 context sentences
    Summary · context
    Fifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg.
    Summary · context
    Semaglutide plasma concentrations were assessed ≤480 h post-dose; the primary endpoint was the area under the plasma concentration-time curve from time zero to infinity.
  3. 03HumanNon-randomized trialPharmacokinetics

    After adjustment for sex, age and body weight, all semaglutide exposure comparisons between renal groups were within the pre-specified clinically relevant limits.

    In plain wordsAfter adjusting for sex, age and weight, semaglutide levels in all kidney function groups were within the accepted limits.

    Peptide
    Semaglutide
    Outcome
    No significant changeAdjusted semaglutide exposure across renal groups
    Study

    n = 56

    Comparator
    Subjects with normal renal function
    Outcome group
    Pharmacokinetics · Kidney and urinary
    Studied dose
    0.5 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    When adjusted for differences in sex, age, and body weight between the groups, all comparisons were within the pre-specified clinically relevant limits.
    2 context sentences
    Summary · context
    Fifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg.
    Summary · context
    Semaglutide plasma concentrations were assessed ≤480 h post-dose; the primary endpoint was the area under the plasma concentration-time curve from time zero to infinity.
  4. 04HumanNon-randomized trialPharmacokinetics

    Across renal impairment groups, creatinine clearance was not related to semaglutide exposure or Cmax.

    In plain wordsAcross kidney function groups, kidney function was not related to semaglutide levels.

    Peptide
    Semaglutide
    Outcome
    No significant changeRelationship of creatinine clearance with semaglutide exposure and Cmax
    Study

    n = 56

    Outcome group
    Pharmacokinetics · Kidney and urinary
    Studied dose
    0.5 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Across RI groups there was no relationship between creatinine clearance (CLCR) and semaglutide exposure, or between CLCR and semaglutide maximum plasma drug concentration (C max).
    2 context sentences
    Summary · context
    Fifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg.
    Summary · context
    Semaglutide plasma concentrations were assessed ≤480 h post-dose; the primary endpoint was the area under the plasma concentration-time curve from time zero to infinity.
  5. 05HumanNon-randomized trialPharmacokinetics

    Hemodialysis did not appear to affect the pharmacokinetics of semaglutide.

    In plain wordsDialysis did not seem to change semaglutide levels in the body.

    Peptide
    Semaglutide
    Outcome
    No significant changeEffect of hemodialysis on semaglutide pharmacokinetics
    Study

    n = 56

    Outcome group
    Pharmacokinetics · Kidney and urinary
    Studied dose
    0.5 mg · subcutaneous · single doseAs given in this study (human).

    Source sentences

    Summary
    Hemodialysis did not appear to affect the pharmacokinetics of semaglutide.
    2 context sentences
    Summary · context
    Fifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg.
    Summary · context
    Semaglutide plasma concentrations were assessed ≤480 h post-dose; the primary endpoint was the area under the plasma concentration-time curve from time zero to infinity.
  6. 06HumanNon-randomized trialSafety outcome

    After a single 0.5 mg dose of semaglutide, there were no appreciable changes in safety parameters or vital signs and no serious adverse events.

    In plain wordsAfter one semaglutide dose, no meaningful changes in safety measures or serious side effects were seen.

    Peptide
    Semaglutide
    Outcome
    No significant changeSafety parameters, vital signs and serious adverse events
    Study

    n = 56

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

    Source sentences

    Summary
    No appreciable changes in safety parameters or vital signs and no serious adverse events were noted.
    2 context sentences
    Summary · context
    Fifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg.
    Summary · context
    Semaglutide plasma concentrations were assessed ≤480 h post-dose; the primary endpoint was the area under the plasma concentration-time curve from time zero to infinity.
  7. 07HumanNon-randomized trialSafety outcome

    One subject with severe renal impairment reported two major hypoglycemic events after semaglutide.

    In plain wordsOne person with severe kidney impairment had two major low blood sugar events after semaglutide.

    Peptide
    Semaglutide
    Outcome
    Not applicableMajor hypoglycemic events
    Study

    n: not reported in source

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

    Source sentences

    Summary
    One subject with severe RI reported two major hypoglycemic events.
    2 context sentences
    Summary · context
    Fifty-six subjects, categorized into renal function groups [normal, mild, moderate, severe, and end-stage renal disease (ESRD)], received a single subcutaneous dose of semaglutide 0.5 mg.
    Summary · context
    Semaglutide plasma concentrations were assessed ≤480 h post-dose; the primary endpoint was the area under the plasma concentration-time curve from time zero to infinity.

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

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 1NCT00833716

Effect of Renal Impairment on the Pharmacokinetics of NN9535

Novo Nordisk A/Sn = 622 Feb 2009 to 26 Jul 2010

Diabetes · Diabetes Mellitus, Type 2 · Renal Impairment

Trial pageClinicalTrials.govUpdated 4 Apr 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.

PepBank is a research reference. Talk to a doctor before you use any peptide.