Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment.

Baekdal TA, Thomsen M, Kupčová V, Hansen CW, Anderson TW

Journal of clinical pharmacology25 Apr 2018Cited by 70 (Europe PMC)

PMID29693715PMCIDPMC6175428DOI10.1002/jcph.1131PepBankPUB-29693715

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Summary

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Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanNon-randomized trialPharmacokinetics
Oral semaglutide AUC from 0-24 hours after the 10th dose appeared similar across hepatic function groups.
In plain wordsLiver impairment did not appear to change how much oral semaglutide was in the blood.
Peptide
Semaglutide
Outcome
No significant changeSemaglutide AUC0-24h after the 10th dose by hepatic function
Study
n = 56
Comparator
Normal hepatic function
Analysis
Primary
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Source sentences
Summary
Area under the semaglutide plasma concentration-time curve from 0-24 hours after the 10th dose (primary end point) and maximum semaglutide concentration after the 10th dose appeared similar across hepatic function groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were classified into groups: normal hepatic function (n = 24), and mild (n = 12), moderate (n = 12), or severe (n = 8) hepatic impairment according to Child-Pugh criteria, and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days).
Report a problemFND-2969371501
02HumanNon-randomized trialPharmacokinetics
Oral semaglutide maximum concentration after the 10th dose appeared similar across hepatic function groups.
In plain wordsLiver impairment did not appear to change the peak level of oral semaglutide in the blood.
Peptide
Semaglutide
Outcome
No significant changeSemaglutide Cmax after the 10th dose by hepatic function
Study
n = 56
Comparator
Normal hepatic function
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Source sentences
Summary
Area under the semaglutide plasma concentration-time curve from 0-24 hours after the 10th dose (primary end point) and maximum semaglutide concentration after the 10th dose appeared similar across hepatic function groups.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were classified into groups: normal hepatic function (n = 24), and mild (n = 12), moderate (n = 12), or severe (n = 8) hepatic impairment according to Child-Pugh criteria, and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days).
Report a problemFND-2969371502
03HumanNon-randomized trialPharmacokinetics
Hepatic impairment had no apparent effect on time to maximum concentration of oral semaglutide.
In plain wordsLiver impairment had no apparent effect on how fast oral semaglutide reached its peak level.
Peptide
Semaglutide
Outcome
No significant changeTime to maximum semaglutide concentration by hepatic function
Study
n = 56
Comparator
Normal hepatic function
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Measurements
Time to maximum concentration
1 to 1.5 hours
median range across groups
Source sentences
Summary
Similarly, there was no apparent effect of hepatic impairment on time to maximum semaglutide concentration (median range 1.0-1.5 hours) or half-life (geometric mean range 142-156 hours).
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were classified into groups: normal hepatic function (n = 24), and mild (n = 12), moderate (n = 12), or severe (n = 8) hepatic impairment according to Child-Pugh criteria, and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days).
Report a problemFND-2969371503
04HumanNon-randomized trialPharmacokinetics
Hepatic impairment had no apparent effect on the half-life of oral semaglutide.
In plain wordsLiver impairment had no apparent effect on how long oral semaglutide stayed in the body.
Peptide
Semaglutide
Outcome
No significant changeSemaglutide half-life by hepatic function
Study
n = 56
Comparator
Normal hepatic function
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Measurements
Half-life
142 to 156 hours
geometric mean range across groups
Source sentences
Summary
Similarly, there was no apparent effect of hepatic impairment on time to maximum semaglutide concentration (median range 1.0-1.5 hours) or half-life (geometric mean range 142-156 hours).
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were classified into groups: normal hepatic function (n = 24), and mild (n = 12), moderate (n = 12), or severe (n = 8) hepatic impairment according to Child-Pugh criteria, and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days).
Report a problemFND-2969371504
05HumanNon-randomized trialSafety outcome
No safety concerns were identified, and adverse events matched those seen with other GLP-1 receptor agonists, in subjects with hepatic impairment given oral semaglutide.
In plain wordsNo safety concerns were found in people with liver impairment, and side effects matched those of similar drugs.
Peptide
Semaglutide
Outcome
Not applicableSafety of oral semaglutide in hepatic impairment
Study
n = 56
Outcome group
Adverse events · Whole body
Studied dose
5 mg for 5 days followed by 10 mg for 5 days · oral · 10 daysAs given in this study (human).
Source sentences
Summary
No safety concerns were identified in subjects with hepatic impairment receiving semaglutide. Reported adverse events were in line with those observed for other glucagon-like peptide-1 receptor agonists.
1 context sentence(design, population, supporting numbers)
Summary · context
Subjects were classified into groups: normal hepatic function (n = 24), and mild (n = 12), moderate (n = 12), or severe (n = 8) hepatic impairment according to Child-Pugh criteria, and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days).
Report a problemFND-2969371505

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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 1NCT02016911