Trial reportJournal of clinical pharmacology2018
Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment.
Trial report in Journal of clinical pharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT02016911. Cited by 40 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.
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
Open the trial in the graphWho cites it
40 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.
- Clinical Pharmacokinetics of Semaglutide: A Systematic Review.Drug design, development and therapy · 2024Pooled it
- Renal or Hepatic Impairment Does Not Affect Pharmacokinetics, Safety, or Tolerability of Subcutaneous Cagrilintide.Clinical pharmacokinetics · 2026Trial
- Effect of Various Dosing Schedules on the Pharmacokinetics of Oral Semaglutide: A Randomised Trial in Healthy Subjects.Clinical pharmacokinetics · 2023Trial
- Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects.Clinical pharmacokinetics · 2021Trial
- Relationship Between Oral Semaglutide Tablet Erosion and Pharmacokinetics: A Pharmacoscintigraphic Study.Clinical pharmacology in drug development · 2021Trial
- Article
- Semaglutide - properties, action and chromatographic analysis.Journal of diabetes and metabolic disorders · 2025Review
- The expanding role of semaglutide: beyond glycemic control.Journal of diabetes and metabolic disorders · 2025Review
- Semaglutide-associated drug-induced liver injury: a case report and review of the literature.Oxford medical case reports · 2025Article
- Clinical development of oral semaglutide for the treatment of type 2 diabetes mellitus: focusing on early phase clinical trials.Translational and clinical pharmacology · 2025Review
- A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants.Diabetes therapy : research, treatment and education of diabetes and related disorders · 2025Article
- Subcutaneous Semaglutide during Breastfeeding: Infant Safety Regarding Drug Transfer into Human Milk.Nutrients · 2024Article
- Safety and efficacy of semaglutide in post kidney transplant patients with type 2 diabetes or Post-Transplant diabetes.Journal of clinical & translational endocrinology · 2024Article
- Evolving role of semaglutide in NAFLD: in combination, weekly and oral administration.Frontiers in pharmacology · 2024Review
- Current Understanding of Sodium N-(8-[2-Hydroxylbenzoyl] Amino) Caprylate (SNAC) as an Absorption Enhancer: The Oral Semaglutide Experience.Clinical diabetes : a publication of the American Diabetes Association · 2024Article
- Gastrointestinal Permeation Enhancers for the Development of Oral Peptide Pharmaceuticals.Pharmaceuticals (Basel, Switzerland) · 2022Review
- A new era for oral peptides: SNAC and the development of oral semaglutide for the treatment of type 2 diabetes.Reviews in endocrine & metabolic disorders · 2022Review
- Design and Development of a New Glucagon-Like Peptide-1 Receptor Agonist to Obtain High Oral Bioavailability.Pharmaceutical research · 2022Article
- Population Pharmacokinetics of Cotadutide in Subjects with Type 2 Diabetes.Clinical pharmacokinetics · 2022Article
- Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes.Reviews in endocrine & metabolic disorders · 2022 · on this mapReview
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 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Semaglutide is a human glucagon-like peptide-1 analog that has been co-formulated with the absorption enhancer, sodium N-(8-[2-hydroxybenzoyl] amino) caprylate, for oral administration. This trial (NCT02016911) investigated whether hepatic impairment affects the pharmacokinetics, safety, and tolerability of oral semaglutide. Subjects were classified into groups: normal hepatic function (n = 24), and mild (n = 12), moderate (n = 12), or severe (n = 8) hepatic impairment according to Child-Pugh criteria, and received once-daily oral semaglutide (5 mg for 5 days followed by 10 mg for 5 days). Semaglutide plasma concentrations were measured during dosing and for up to 21 days post-last dose. Area under the semaglutide plasma concentration-time curve from 0-24 hours after the 10th dose (primary end point) and maximum semaglutide concentration after the 10th dose appeared similar across hepatic function groups. Similarly, there was no apparent effect of hepatic impairment on time to maximum semaglutide concentration (median range 1.0-1.5 hours) or half-life (geometric mean range 142-156 hours). No safety concerns were identified in subjects with hepatic impairment receiving semaglutide. Reported adverse events were in line with those observed for other glucagon-like peptide-1 receptor agonists. There was no apparent effect of hepatic impairment on the pharmacokinetics, safety, and tolerability of oral semaglutide. The results of this trial suggest that dose adjustment of oral semaglutide is not warranted in subjects with hepatic impairment.
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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 Socratic graph.