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

NCT02016911 · Completed

Last updated 2026-05-28

This clinical trial is testing how a diabetes medication called semaglutide is absorbed, processed, and tolerated in the body by people with liver problems and healthy volunteers.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) treatment study

Participants 56 people

Who can join Ages 18–85 · all sexes Healthy volunteers accepted.

Timeline Started 2013-12 · est. completion 2015-01

Where 6 sites · Czechia, Poland, Slovakia

What this study is testing ClinicalTrials.gov NCT02016911 ↗

Description as written by the study sponsor.

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.

Treatments tested

semaglutide Drug

Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg

Main thing measured	Area under the semaglutide plasma concentration curve
Sponsor	Novo Nordisk A/S
Conditions studied	Diabetes, Diabetes Mellitus, Type 2, Healthy
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02016911 ↗