Investigating the Pharmacokinetics, Safety and Tolerability After a Single Subcutaneous Injection of Semaglutide in Subjects With Mild, Moderate or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Phase 1 Completed 44 enrolled Novo Nordisk A/S

RandomizedParallel-groupOpen-labelTreatment

Summary

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body), safety and tolerability after a single injection of semaglutide in subjects with mild, moderate or severe hepatic impairment compared to subjects with normal hepatic function.

Timeline

Start: 2014-08-07
Primary completion: 2015-06-03
Completion: 2015-06-03

Outcome

Met primary endpoint

paper Semaglutide exposure was similar across all groups, with AUC0-∞ treatment ratios for mild impairment/normal function of 0.95 (90% CI 0.77, 1.16), PMID 29205786 ↗

paper moderate impairment/normal function 1.02 (90% CI 0.93, 1.12), and severe impairment/normal function 0.97 (90% CI 0.84, 1.12). PMID 29205786 ↗

Publications

Results Jensen L, Kupcova V, Arold G, Pettersson J, Hjerpsted JB. Pharmacokinetics and tolerability of semaglutide in people with hepatic impairment. Diabetes Obes Metab. 2018 Apr;20(4):998-1005. doi: 10.1111/dom.13186. Epub 2018 Jan 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Semaglutide	Peptide	0.5 mg	Subcutaneous