Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects.

Jordy AB, Albayaty M, Breitschaft A, Anderson TW, Christiansen E, Houshmand-Øregaard A, Manigandan E, Bækdal TA

Clinical pharmacokinetics1 Sept 2021Cited by 19 (Europe PMC)

PMID33782832PMCIDPMC8416862DOI10.1007/s40262-020-00976-xPepBankPUB-33782832

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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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanNon-randomized trialPharmacokinetics
In healthy subjects, oral semaglutide raised furosemide AUC and the no-effect criterion was not met.
In plain wordsIn healthy people, oral semaglutide raised the amount of furosemide in the blood.
Peptide
Semaglutide
Outcome
IncreaseFurosemide AUC
Study
n = 41
Comparator
Drug given alone
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Measurements
AUC ratio
1.28 ratio
furosemide
Source sentences
Summary
The no-effect criterion was not met for furosemide or rosuvastatin for the AUC (1.28 [1.16-1.42] and 1.41 [1.24-1.60], respectively) or C_max.
3 context sentences(design, population, supporting numbers)
Summary · context
There was a small increase in exposure of furosemide and rosuvastatin; however, these increases are not expected to be of clinical relevance.
Summary · context
Two separate one-sequence crossover trials investigated the effects of oral semaglutide and SNAC on the pharmacokinetics of ethinylestradiol, levonorgestrel, furosemide and rosuvastatin.
Summary · context
Healthy, postmenopausal women (n = 25) received once-daily combined ethinylestradiol and levonorgestrel (Trial 1) and healthy male and female subjects (n = 41) received single doses of furosemide and rosuvastatin (Trial 2), either alone, with SNAC alone or with oral semaglutide.
Report a problemFND-3378283205
02HumanNon-randomized trialPharmacokinetics
In healthy subjects, oral semaglutide raised rosuvastatin AUC and the no-effect criterion was not met.
In plain wordsIn healthy people, oral semaglutide raised the amount of rosuvastatin in the blood.
Peptide
Semaglutide
Outcome
IncreaseRosuvastatin AUC
Study
n = 41
Comparator
Drug given alone
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Measurements
AUC ratio
1.41 ratio
rosuvastatin
Source sentences
Summary
The no-effect criterion was not met for furosemide or rosuvastatin for the AUC (1.28 [1.16-1.42] and 1.41 [1.24-1.60], respectively) or C_max.
3 context sentences(design, population, supporting numbers)
Summary · context
There was a small increase in exposure of furosemide and rosuvastatin; however, these increases are not expected to be of clinical relevance.
Summary · context
Two separate one-sequence crossover trials investigated the effects of oral semaglutide and SNAC on the pharmacokinetics of ethinylestradiol, levonorgestrel, furosemide and rosuvastatin.
Summary · context
Healthy, postmenopausal women (n = 25) received once-daily combined ethinylestradiol and levonorgestrel (Trial 1) and healthy male and female subjects (n = 41) received single doses of furosemide and rosuvastatin (Trial 2), either alone, with SNAC alone or with oral semaglutide.
Report a problemFND-3378283206
03HumanNon-randomized trialPharmacokinetics
In healthy subjects, the no-effect criterion was not met for furosemide Cmax with oral semaglutide; exposure rose slightly.
In plain wordsIn healthy people, oral semaglutide slightly raised peak furosemide levels.
Peptide
Semaglutide
Outcome
IncreaseFurosemide Cmax
Study
n = 41
Comparator
Drug given alone
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
The no-effect criterion was not met for furosemide or rosuvastatin for the AUC (1.28 [1.16-1.42] and 1.41 [1.24-1.60], respectively) or C_max.
3 context sentences(design, population, supporting numbers)
Summary · context
There was a small increase in exposure of furosemide and rosuvastatin; however, these increases are not expected to be of clinical relevance.
Summary · context
Two separate one-sequence crossover trials investigated the effects of oral semaglutide and SNAC on the pharmacokinetics of ethinylestradiol, levonorgestrel, furosemide and rosuvastatin.
Summary · context
Healthy, postmenopausal women (n = 25) received once-daily combined ethinylestradiol and levonorgestrel (Trial 1) and healthy male and female subjects (n = 41) received single doses of furosemide and rosuvastatin (Trial 2), either alone, with SNAC alone or with oral semaglutide.
Report a problemFND-3378283207
04HumanNon-randomized trialPharmacokinetics
In healthy subjects, the no-effect criterion was not met for rosuvastatin Cmax with oral semaglutide; exposure rose slightly.
In plain wordsIn healthy people, oral semaglutide slightly raised peak rosuvastatin levels.
Peptide
Semaglutide
Outcome
IncreaseRosuvastatin Cmax
Study
n = 41
Comparator
Drug given alone
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
The no-effect criterion was not met for furosemide or rosuvastatin for the AUC (1.28 [1.16-1.42] and 1.41 [1.24-1.60], respectively) or C_max.
3 context sentences(design, population, supporting numbers)
Summary · context
There was a small increase in exposure of furosemide and rosuvastatin; however, these increases are not expected to be of clinical relevance.
Summary · context
Two separate one-sequence crossover trials investigated the effects of oral semaglutide and SNAC on the pharmacokinetics of ethinylestradiol, levonorgestrel, furosemide and rosuvastatin.
Summary · context
Healthy, postmenopausal women (n = 25) received once-daily combined ethinylestradiol and levonorgestrel (Trial 1) and healthy male and female subjects (n = 41) received single doses of furosemide and rosuvastatin (Trial 2), either alone, with SNAC alone or with oral semaglutide.
Report a problemFND-3378283208
05HumanNon-randomized trialPharmacokinetics
In healthy postmenopausal women, oral semaglutide co-administration did not change ethinylestradiol AUC.
In plain wordsIn healthy postmenopausal women, taking oral semaglutide did not change how much ethinylestradiol reached the blood.
Peptide
Semaglutide
Outcome
No significant changeEthinylestradiol AUC
Study
n = 25
Comparator
Drug given alone
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Measurements
AUC ratio
1.06 ratio
ethinylestradiol
Source sentences
Summary
The AUC values of ethinylestradiol and levonorgestrel were not affected by oral semaglutide co-administration (estimated ratios [90% CI] 1.06 [1.01-1.10] and 1.06 [0.97-1.17], respectively); C_max was not affected.
2 context sentences(design, population, supporting numbers)
Summary · context
Two separate one-sequence crossover trials investigated the effects of oral semaglutide and SNAC on the pharmacokinetics of ethinylestradiol, levonorgestrel, furosemide and rosuvastatin.
Summary · context
Healthy, postmenopausal women (n = 25) received once-daily combined ethinylestradiol and levonorgestrel (Trial 1) and healthy male and female subjects (n = 41) received single doses of furosemide and rosuvastatin (Trial 2), either alone, with SNAC alone or with oral semaglutide.
Report a problemFND-3378283201
06HumanNon-randomized trialPharmacokinetics
In healthy postmenopausal women, oral semaglutide co-administration did not change levonorgestrel AUC.
In plain wordsIn healthy postmenopausal women, taking oral semaglutide did not change how much levonorgestrel reached the blood.
Peptide
Semaglutide
Outcome
No significant changeLevonorgestrel AUC
Study
n = 25
Comparator
Drug given alone
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Measurements
AUC ratio
1.06 ratio
levonorgestrel
Source sentences
Summary
The AUC values of ethinylestradiol and levonorgestrel were not affected by oral semaglutide co-administration (estimated ratios [90% CI] 1.06 [1.01-1.10] and 1.06 [0.97-1.17], respectively); C_max was not affected.
2 context sentences(design, population, supporting numbers)
Summary · context
Two separate one-sequence crossover trials investigated the effects of oral semaglutide and SNAC on the pharmacokinetics of ethinylestradiol, levonorgestrel, furosemide and rosuvastatin.
Summary · context
Healthy, postmenopausal women (n = 25) received once-daily combined ethinylestradiol and levonorgestrel (Trial 1) and healthy male and female subjects (n = 41) received single doses of furosemide and rosuvastatin (Trial 2), either alone, with SNAC alone or with oral semaglutide.
Report a problemFND-3378283202
07HumanNon-randomized trialPharmacokinetics
In healthy postmenopausal women, oral semaglutide co-administration did not change ethinylestradiol Cmax.
In plain wordsIn healthy postmenopausal women, oral semaglutide did not change peak ethinylestradiol levels.
Peptide
Semaglutide
Outcome
No significant changeEthinylestradiol Cmax
Study
n = 25
Comparator
Drug given alone
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
The AUC values of ethinylestradiol and levonorgestrel were not affected by oral semaglutide co-administration (estimated ratios [90% CI] 1.06 [1.01-1.10] and 1.06 [0.97-1.17], respectively); C_max was not affected.
2 context sentences(design, population, supporting numbers)
Summary · context
Two separate one-sequence crossover trials investigated the effects of oral semaglutide and SNAC on the pharmacokinetics of ethinylestradiol, levonorgestrel, furosemide and rosuvastatin.
Summary · context
Healthy, postmenopausal women (n = 25) received once-daily combined ethinylestradiol and levonorgestrel (Trial 1) and healthy male and female subjects (n = 41) received single doses of furosemide and rosuvastatin (Trial 2), either alone, with SNAC alone or with oral semaglutide.
Report a problemFND-3378283203
08HumanNon-randomized trialPharmacokinetics
In healthy postmenopausal women, oral semaglutide co-administration did not change levonorgestrel Cmax.
In plain wordsIn healthy postmenopausal women, oral semaglutide did not change peak levonorgestrel levels.
Peptide
Semaglutide
Outcome
No significant changeLevonorgestrel Cmax
Study
n = 25
Comparator
Drug given alone
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
The AUC values of ethinylestradiol and levonorgestrel were not affected by oral semaglutide co-administration (estimated ratios [90% CI] 1.06 [1.01-1.10] and 1.06 [0.97-1.17], respectively); C_max was not affected.
2 context sentences(design, population, supporting numbers)
Summary · context
Two separate one-sequence crossover trials investigated the effects of oral semaglutide and SNAC on the pharmacokinetics of ethinylestradiol, levonorgestrel, furosemide and rosuvastatin.
Summary · context
Healthy, postmenopausal women (n = 25) received once-daily combined ethinylestradiol and levonorgestrel (Trial 1) and healthy male and female subjects (n = 41) received single doses of furosemide and rosuvastatin (Trial 2), either alone, with SNAC alone or with oral semaglutide.
Report a problemFND-3378283204
09HumanNon-randomized trialSafety outcome
In both trials, adverse events with oral semaglutide were similar to those previously seen for GLP-1 receptor agonists.
In plain wordsIn both trials, side effects of oral semaglutide were similar to those seen before with this drug class.
Peptide
Semaglutide
Outcome
Not applicableAdverse events
Study
n: not reported in source
Outcome group
Adverse events · Pharmacology
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
Adverse events were similar to those previously observed for GLP-1RAs (both trials).
2 context sentences(design, population, supporting numbers)
Summary · context
Two separate one-sequence crossover trials investigated the effects of oral semaglutide and SNAC on the pharmacokinetics of ethinylestradiol, levonorgestrel, furosemide and rosuvastatin.
Summary · context
Healthy, postmenopausal women (n = 25) received once-daily combined ethinylestradiol and levonorgestrel (Trial 1) and healthy male and female subjects (n = 41) received single doses of furosemide and rosuvastatin (Trial 2), either alone, with SNAC alone or with oral semaglutide.
Report a problemFND-3378283209

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 1NCT03010475

A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects

Novo Nordisk A/Sn = 415 Jan 2017 to 9 Aug 2017

Diabetes · Healthy

Trial page ClinicalTrials.govUpdated 20 Dec 2017

CompletedPhase 1NCT02845219

A Trial Investigating the Influence of Oral Semaglutide on Pharmacokinetics of Ethinylestradiol and Levonorgestrel in an Oral Contraceptive Combination Drug in Healthy Postmenopausal Females

Novo Nordisk A/Sn = 25Jul 2016 to Dec 2016

Diabetes · Diabetes Mellitus, Type 2

Trial page ClinicalTrials.govUpdated 7 Jun 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.

Version 2Current
11 Oct 2026, 00:50 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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