Safety of Liraglutide in Subjects With Liver Impairment and in Subjects With Normal Liver Function

A Single-centre, Open-label Trial Investigating the Pharmacokinetics and the Safety Profile After a Single Dose of Liraglutide in Subjects With Hepatic Impairment and in Subjects With Normal Hepatic Function

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01507389

Enrollment

Registered

2012-01-10

Start date

2006-03-31

Completion date

2006-06-30

Last updated

2014-12-09

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

Brief summary

This trial is conducted in Europe. The aim of this trial is to investigate liraglutide in subjects with mild, moderate and severe degrees of hepatic impairment compared with subjects with normal hepatic function.

Interventions

DRUGliraglutide

Single dose of 0.75 mg injected subcutaneously (under the skin)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

Inclusion criteria

* Subjects with normal hepatic function and liver parameters within normal range * Subjects with stable hepatic impairment classified as Child-Pugh grade A, B or C * Body Mass Index between 18.5-40.0 kg/m\^2 (both inclusive)

Exclusion criteria

* Known or suspected allergy to trial product or related products * Liver transplanted subjects * Cardiac problems * Uncontrolled treated/untreated hypertension * Signs of acute liver insufficiency * Positive HIV (human immunodeficiency virus) 1+2 antibodies * Cancer or any clinically significant disease or disorder except for conditions associated with the hepatic impairment * Impaired renal function * Smoking of more than 10 cigarettes per day, or the equivalent for other tobacco products * Habitual excessive consumption of methylxanthine-containing beverages and foods (coffee, tea, soft drinks such as cola, chocolate) as judged by the investigator

Design outcomes

Primary

Measure	Time frame
Area under the Curve (0-infinity)	—

Secondary

Measure	Time frame
Area under the Curve (0-t)	—
Cmax, maximum concentration	—
tmax, time to maximum concentration	—
t½, terminal half-life	—
Adverse events	—

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026