Trial reportClinical pharmacokinetics2023
Effect of Various Dosing Schedules on the Pharmacokinetics of Oral Semaglutide: A Randomised Trial in Healthy Subjects.
Trial report in Clinical pharmacokinetics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It reports registered trial NCT04513704. Cited by 14 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Oral Semaglutide Pharmacokinetics in Healthy Subjects, Effect of Dosing Schedules
Open the trial in the graphWho cites it
14 citing papers in PubMed, 2 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- The adverse effects associated with semaglutide use in patients at increased risk of cardiovascular events: a systematic review with meta-analysis and Trial Sequential Analysis.BMC medicine · 2025 · on this mapPooled it
- Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024Pooled it
- Oral GLP-1RA TERN-601 for Adults With Obesity/Overweight: Placebo-Controlled, Multiple-Ascending-Dose, Phase 1 and 2 Studies.Obesity (Silver Spring, Md.) · 2026Trial
- Salcaprozate Sodium as a Permeation Enhancer-Mechanism, Applications and Unresolved Questions.Pharmaceutics · 2026Review
- Semaglutide Bioavailability: Limitations, Formulation Innovation and Future Opportunities.Pharmaceutical research · 2026Review
- Efficacy and safety of orforglipron, an oral small-molecule GLP-1 receptor agonist, on cardiometabolic outcomes: a meta-analysis and systematic review.Cardiovascular diabetology. Endocrinology reports · 2026Review
- Adipose Tissue Circadian Dysregulation Beyond BMI: Implications for Cardiometabolic Risk and Cardiovascular Disease.Life (Basel, Switzerland) · 2026Review
- Food-drug interactions of novel drugs used in cardiologic and diabetic patients - a PRISMA scoping review.Frontiers in pharmacology · 2026Review
- Semaglutide - properties, action and chromatographic analysis.Journal of diabetes and metabolic disorders · 2025Review
- The Chronobiology of Hormone Administration: "Doctor, What Time Should I Take My Medication?"Endocrine reviews · 2025Review
- The Long-Term Cost-Effectiveness of Oral Semaglutide Versus Lower-Cost Liraglutide in the UK.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
- A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
- Suitability and Usefulness of a Flexible Dosing Timing of Oral Semaglutide to Maximize Benefit in Clinical Practice: An Expert Panel.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2024Review
- Enhanced Oral Efficacy of Semaglutide via an Ionic Nanocomplex with Organometallic Phyllosilicate in Type 2 Diabetic Rats.Pharmaceutics · 2024Article
Corrections and comments
- Erratum issued
Authors and funding
5 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPrescribing information instructs taking oral semaglutide (a glucagon-like peptide-1 analogue) in the fasting state, followed by a post-dose fasting period of ≥ 30 min. This trial compared the recommended dosing schedule with alternative schedules.
methodsThis was a randomised, single-centre, multiple-dose, open-label, five-armed, parallel-group trial in healthy subjects who received once-daily oral semaglutide (3 mg for 5 days followed by 7 mg for 5 days). Subjects (n = 156) were randomised to five dosing schedules: 2-, 4-, or 6-h pre-dose fast followed by a 30-min post-dose fast (treatment arms: 2 h-30 min, 4-30 min, 6 h-30 min); 2-h pre-dose fast followed by an overnight post-dose fast (treatment arm: 2 h-night); or overnight pre-dose fast followed by a 30-min post-dose fast (reference arm: night-30 min). Semaglutide plasma concentration was measured regularly until 24 h after the 10th dose. Endpoints included area under the semaglutide plasma concentration-time curve during a 24-h interval after the 10th dose (AUC
resultsCompared with an overnight pre-dose fast (reference arm: night-30 min), shorter pre-dose fasting times in the 2 h-night, 2 h-30 min, 4 h-30 min, and 6 h-30 min treatment arms resulted in significantly lower semaglutide AUC
conclusionThis trial supports dosing oral semaglutide in accordance with prescribing information, which requires dosing in the fasting state.
trial registrationClinicalTrials.gov (NCT04513704); registered August 14, 2020.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.