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NCT02016911

Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment

Completed Phase 1 Last updated 15 May 2018
What this trial tests

Phase 1 trial testing semaglutide in Diabetes in 56 participants. Completed in 12 January 2015.

Timeline
12 December 2013
Primary endpoint
12 January 2015
12 January 2015

Quick facts

Lead sponsorNovo Nordisk A/S
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment56
Start date12 December 2013
Primary completion12 January 2015
Estimated completion12 January 2015
Sites6 locations across Slovakia, Poland, Czechia

Drugs / interventions tested

Conditions studied

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

Adults 18 to 85, any sex, with Diabetes or Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), 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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Intestinal Permeation Enhancers for Oral Delivery of Macromolecules: A Comparison between Salcaprozate Sodium (SNAC) and Sodium Caprate (C<sub>10</sub>).
    Twarog C, Fattah S, Heade J, Maher S, et al · · 2019 · cited 153× · PMID 30781867 · DOI 10.3390/pharmaceutics11020078
  2. Semaglutide, a glucagon like peptide-1 receptor agonist with cardiovascular benefits for management of type 2 diabetes.
    Mahapatra MK, Karuppasamy M, Sahoo BM. · · 2022 · cited 92× · PMID 34993760 · DOI 10.1007/s11154-021-09699-1
  3. Clinical Pharmacokinetics of Oral Semaglutide: Analyses of Data from Clinical Pharmacology Trials.
    Overgaard RV, Navarria A, Ingwersen SH, Bækdal TA, et al · · 2021 · cited 83× · PMID 33969456 · DOI 10.1007/s40262-021-01025-x
  4. Pharmacokinetics, Safety, and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment.
    Baekdal TA, Thomsen M, Kupčová V, Hansen CW, et al · · 2018 · cited 64× · PMID 29693715 · DOI 10.1002/jcph.1131
  5. 53 &lt;sup&gt;rd&lt;/sup&gt; EASD Annual Meeting of the European Association for the Study of Diabetes : Lisbon, Portugal, 11 - 15 September 2017.
    · 2017 · cited 17× · PMID 28795195 · DOI 10.1007/s00125-017-4350-z
  6. Clinical development of oral semaglutide for the treatment of type 2 diabetes mellitus: focusing on early phase clinical trials.
    Won H, Cho JY, Lee S. · · 2025 · cited 4× · PMID 40206874 · DOI 10.12793/tcp.2025.33.e3

Verify or expand the search:

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Other Novo Nordisk A/S trials

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing