ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2025
A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT05227196. Cited by 3 papers.
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A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants
Open the trial in the graphWho cites it
3 citing papers in PubMed.
- The fourth controlled release society workshop on oral peptide administration.Frontiers in drug delivery · 2026Article
- Semaglutide - properties, action and chromatographic analysis.Journal of diabetes and metabolic disorders · 2025Review
- GLP-1R in diabetes mellitus: from basic discovery to therapeutics development.Frontiers in pharmacology · 2025Review
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8 authors.
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Abstract
introductionThe glucagon-like peptide-1 (GLP-1) analogue semaglutide is approved as an oral formulation for the treatment of type 2 diabetes. This study aimed to confirm bioequivalence between a new, second-generation (2G) oral semaglutide formulation (1.5, 4 and 9 mg) and the initially approved first-generation (1G) formulation (3, 7 and 14 mg).
methodsThis was a randomised, multicentre, open-label, full replicate crossover study to confirm bioequivalence between 2G and 1G oral semaglutide formulations at steady-state (SS) in healthy participants (NCT05227196). Participants were recruited to three groups. In each group, participants were randomised to one of two alternating sequences comparing once-daily oral semaglutide treatment of 9 and 14 mg (group 1), 4 and 7 mg (group 2) or 1.5 and 3 mg (group 3) at SS. Treatment duration was 20 weeks, comprising four 5-week steady-state periods on alternating formulations. Repeated 24-h blood sampling at the end of each steady-state period supported pharmacokinetic analysis. Co-primary endpoints were area under the semaglutide plasma concentration-time curve during a dosing interval at SS (AUC
resultsA total of 222, 201 and 123 participants were recruited into groups 1, 2 and 3, respectively. The prespecified EMA, FDA and PMDA bioequivalence criteria were met for 2G versus 1G oral semaglutide for all three dose levels (1.5 vs 3 mg, 4 vs 7 mg and 9 vs 14 mg). The safety profile of 2G oral semaglutide was consistent with 1G oral semaglutide.
conclusionsThe 2G oral semaglutide formulation was confirmed as bioequivalent to 1G oral semaglutide, with no new safety concerns identified.
trial registrationClinicalTrials.gov identifier, NCT05227196.
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