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NCT02016911
Pharmacokinetics, Safety and Tolerability of Oral Semaglutide in Subjects With Hepatic Impairment
Phase 1 trial testing semaglutide in Diabetes in 56 participants. Completed in 12 January 2015.
12 January 2015
Quick facts
| Lead sponsor | Novo Nordisk A/S |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 12 December 2013 |
| Primary completion | 12 January 2015 |
| Estimated completion | 12 January 2015 |
| Sites | 6 locations across Slovakia, Poland, Czechia |
Drugs / interventions tested
- semaglutide (semaglutide) — full drug profile →
Conditions studied
- Diabetes — all drugs for Diabetes →
- Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →
- Healthy — all drugs for Healthy →
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):
-
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 -
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 -
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 -
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 -
53 <sup>rd</sup> 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 -
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:
- PubMed search for NCT02016911
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of semaglutide
Trials testing the same drug.
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Other recruiting trials for Diabetes
Currently open trials in the same condition.
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- NCT07479134 — Production of Stem Cells for the Generation of Pancreatic Cells · NA · recruiting
- NCT07441655 — Families Implementing Good Health Traditions for Life · NA · recruiting
- NCT06724172 — CHIME: Comparing Health Interventions for Maternal Equity · NA · recruiting
- NCT07417865 — ECHO Diabetes FQHC · recruiting
Other Novo Nordisk A/S trials
Trials by the same sponsor.
- NCT07357740 — A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes · Phase 2 · not yet recruiting
- NCT07282613 — A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adoles · Phase 3 · not yet recruiting
- NCT07357766 — A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight · Phase 3 · not yet recruiting
- NCT07564414 — A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obe · Phase 3 · not yet recruiting
- NCT07400107 — AMAZE 8: A Research Study Investigating How Well the Medicine NNC0487-0111 Compared to Semaglutide Helps People With Exc · Phase 3 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02016911 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
- Last refreshed: 15 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02016911.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing