ArticleClinical pharmacokinetics2021
Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials.
Article in Clinical pharmacokinetics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT01572753. Cited by 64 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Single Centre, Multiple Dose, Open Label Randomised Trial to Evaluate the Effect of Post Dose Meal Timings and the Effect of Volume of Water With Dosing on the Pharmacokinetic Properties of Oral Semaglutide in Healthy Male Subjects
Open the trial in the graphPharmacoscintigraphic Investigation NN9924 in Healthy Male Subjects
Open the trial in the graphInvestigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
Investigation of Pharmacokinetics, Safety and Tolerability of Oral Semaglutide (NNC0113-0217) in Subjects With Mild, Moderate and Severe Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Effect of Food on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects
Open the trial in the graphA Trial Investigating the Influence of Omeprazole on the Pharmacokinetics of Oral Semaglutide in Healthy Subjects
Investigation of the Effect of Upper Gastrointestinal Disease on the Pharmacokinetics of Oral Semaglutide in Subjects With Type 2 Diabetes
Open the trial in the graphWho cites it
64 citing papers in PubMed, 1 synthesis or guideline pooled it, 103 citations in OpenAlex.
- Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024Pooled it
- Oral Semaglutide for Alcohol Use Disorder: A Randomized Clinical Trial.The American journal of psychiatry · 2026Trial
- Gut-derived appetite hormones do not explain energy intake differences in humans following low-carbohydrate versus low-fat diets.Obesity (Silver Spring, Md.) · 2024Trial
- Trial
- Synthesis of withaferin a derivatives and exploratory evaluation of weight reduction and fasting blood glucose in DIO mice.RSC advances · 2026Article
- Gastrointestinal adverse effects of GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists: A narrative expert review of approved therapies, oral formulations, and pipeline agents.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2026Review
- Salcaprozate Sodium as a Permeation Enhancer-Mechanism, Applications and Unresolved Questions.Pharmaceutics · 2026Review
- Oral Incretin-Based Therapies for Weight Management.Current atherosclerosis reports · 2026Review
- Semaglutide Bioavailability: Limitations, Formulation Innovation and Future Opportunities.Pharmaceutical research · 2026Review
- Comment on 'The Impact of Missed Doses on Pharmacokinetic Concentrations for Oral Semaglutide in Comparison to Other Glucagon-Like Peptide-1-Based Therapies'.Diabetes, obesity & metabolism · 2026Article
- The Impact of Missed Doses on Pharmacokinetic Concentrations for Oral Semaglutide in Comparison to Other Glucagon-Like Peptide-1-Based Therapies.Diabetes, obesity & metabolism · 2026Article
- Natural Oral Absorption of Therapeutic Peptides: Mechanisms and Physiological Determinants.Pharmaceutics · 2026Review
- A self-unfolding polymer foil loaded with a permeation enhancer Ionogel for superior oral peptide delivery.Drug delivery and translational research · 2026Article
- Discovery of Biased Dual-Agonists of Glucagon-Like Peptide 1 and Glucagon Receptors through Mutation of a Conserved Aspartate.ACS medicinal chemistry letters · 2026Article
- Estimated Oral Semaglutide Exposure Has Distinct Relationships With Glycaemic Response, Weight Loss and Gastrointestinal Tolerability.Diabetes, obesity & metabolism · 2026Article
- Efficacy, Safety and PK of Once-Daily Oral Semaglutide 25 mg for Obesity With and Without Type 2 Diabetes in Comparison With Subcutaneous Semaglutide 2.4 mg: A Model-Informed Drug Development Approach.Diabetes, obesity & metabolism · 2026Article
- Impact of sodium caprate dosed as a mini-tablet or suspension on insulin delivery and mucosa histomorphology.Drug delivery and translational research · 2026Article
- Future Directions in the Medical Treatment of Obesity: A Narrative Review.Advances in therapy · 2026Review
- GLP-1 Receptor Agonists in Chronic Inflammatory Skin Diseases: Immunometabolic Mechanisms and Translational Perspectives.Pharmaceutics · 2026Review
- Novel Small Molecule GLP-1R Agonists Based on 1Molecules (Basel, Switzerland) · 2026Article
4 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThe absorption, distribution and elimination of oral semaglutide, the first oral glucagon-like peptide-1 receptor agonist for treating type 2 diabetes, was investigated using a population pharmacokinetic model based on data from clinical pharmacology trials.
methodsA previously developed, two-compartment pharmacokinetic model, based on subcutaneous and intravenous semaglutide, was extended to include data from six oral semaglutide trials conducted in either healthy volunteers or subjects with renal or hepatic impairment. Five trials employed multiple doses of oral semaglutide (5-10 mg) and one was a single-dose (10 mg) trial. In a separate analysis, the model was re-estimated using data from a trial in subjects with type 2 diabetes.
resultsThe model accurately described concentration profiles across trials. Post-dose fasting time, co-ingestion of a large water volume, and body weight were the most important covariates affecting semaglutide exposure. Bioavailability was 0.8% when oral semaglutide was dosed using the recommended dosing conditions (30 min post-dose fasting time, administered with ≤ 120 mL of water), increasing with a longer post-dose fasting time and decreasing with higher water volume. Within-subject variability in bioavailability was 137%, which with once-daily dosing and a long half-life translates into 33% within-subject variability in steady-state exposure. There was no significant difference in oral bioavailability of semaglutide in healthy subjects and subjects with type 2 diabetes.
conclusionsThe updated model provided a general characterisation of semaglutide pharmacokinetics following oral, subcutaneous and intravenous administration in healthy subjects and subjects with type 2 diabetes. Within-individual variation of oral bioavailability was relatively high, but reduced considerably at steady state. CLINICALTRIALS. GOV IDENTIFIERS: NCT01572753, NCT01619345, NCT02014259, NCT02016911, NCT02249871, NCT02172313, NCT02877355.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
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.