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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02016911

Enrollment

Registered

2013-12-20

Start date

2013-12-12

Completion date

2015-01-12

Last updated

2018-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2, Healthy

Brief summary

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.

Interventions

DRUGsemaglutide

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* Subject with normal hepatic function or hepatic impairment (mild, moderate or severe) * Body mass index (BMI) 18.5-40.0 kg/m\^2 (both inclusive)

Exclusion criteria

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods * History of Crohn's disease, ulcerative colitis, or other inflammatory bowel disease * Uncontrolled hypertension (defined as systolic blood pressure above or equal to 180 mmHg and/or diastolic blood pressure above or equal to 100 mmHg) * Any donation of blood or plasma in excess of 400 mL within the 3 months preceding screening * History of significant drug abuse, or a positive drug test at the screening visit (Visit 2)

Design outcomes

Primary

Measure	Time frame
Area under the semaglutide plasma concentration curve	From time 0 to 24 hours after the 10th dosing

Secondary

Measure	Time frame
Maximum observed semaglutide plasma concentration	0 to 24 hours after the 10th dosing
Area under the SNAC (Sodium N-[8-(2-hydroxybenzoyl) amino] caprylate /salcaprozate sodium) plasma concentration time curve	From time 0 to 24 hours after the 10th dosing
Maximum observed SNAC plasma concentration	0 to 24 hours after the 10th dosing

Countries

Czechia, Poland, Slovakia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026