Effect of oral semaglutide on the pharmacokinetics of thyroxine after dosing of levothyroxine and the influence of co-administered tablets on the pharmacokinetics of oral semaglutide in healthy subjects: an open-label, one-sequence crossover, single-center, multiple-dose, two-part trial

Jul 22, 2021Expert opinion on drug metabolism & toxicology

How oral semaglutide affects thyroid hormone levels and how other tablets affect semaglutide levels in healthy people

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Abstract

A 33% increase in total thyroxine exposure was observed when levothyroxine was co-administered with oral semaglutide.

The maximum concentration of thyroxine was not affected by the addition of oral semaglutide.
Sodium-(8-[2-hydroxybenzoyl] amino) caprylate alone did not influence total thyroxine exposure.
A 34% decrease in semaglutide exposure occurred when it was taken with multiple placebo tablets.
Co-administration of oral semaglutide with levothyroxine may necessitate monitoring thyroid parameters.
Dosing guidance may need to be adjusted based on the effect of multiple tablets on oral semaglutide exposure.

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BACKGROUND: Oral semaglutide comprises the glucagon-like peptide-1 analog, semaglutide, and sodium-(8-[2-hydroxybenzoyl] amino) caprylate (SNAC). Levothyroxine has similar dosing conditions to oral semaglutide. This trial investigated if oral semaglutide co-administered with levothyroxine affects thyroxine (T) exposure and if multiple placebo tablets co-administered with oral semaglutide affect semaglutide exposure. N4

RESEARCH DESIGN AND METHODS: In this one-sequence crossover trial, 45 healthy subjects received levothyroxine (600 μg single-dose) alone, or with concomitant SNAC 300 mg or concomitant oral semaglutide 14 mg at steady-state. Subjects also received oral semaglutide 14 mg at steady-state alone or with five placebo tablets once-daily for 5 weeks.

RESULTS: A 33% increase in total Texposure was observed with levothyroxine/oral semaglutide vs levothyroxine alone, but baseline-corrected maximum concentration () was unaffected. SNAC alone did not affect total Texposure, whereaswas slightly decreased. A 34% decrease in semaglutide exposure was observed when oral semaglutide was co-administered with placebo tablets, andalso decreased. 4max4max max C C C

CONCLUSIONS: Levothyroxine pharmacokinetics were influenced by co-administration with oral semaglutide. Monitoring of thyroid parameters should be considered when treating patients with both oral semaglutide and levothyroxine. Oral semaglutide exposure was influenced by co-administration with multiple tablets, which is addressed in the dosing guidance.

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Effect of oral semaglutide on the pharmacokinetics of thyroxine after dosing of levothyroxine and the influence of co-administered tablets on the pharmacokinetics of oral semaglutide in healthy subjects: an open-label, one-sequence crossover, single-center, multiple-dose, two-part trial

Abstract

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