CompletedPhase 1

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

Lead sponsor

Novo Nordisk A/S

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Hepatic impairment

Eligibility highlights

•BMI 18.5-40

Primary endpoint

•Area under the Curve (0-infinity)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01507389

Org study IDNN2211-1328

Secondary ID2005-003027-38

Timeline

Milestones

Study first posted2012-01-10estimated

Last update posted2014-12-09estimated

Study start2006-03 (month precision)

Primary completion2006-06actual (month precision)

Study completion2006-06actual (month precision)

Assets

Investigational agents

Liraglutide

Who this study enrolls

Healthy volunteersHepatic impairment

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Area under the Curve (0-infinity)

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Area under the Curve (0-t)

AUC₀-∞

concentration, descriptive

Secondary/protocol endpoint

Cmax, maximum concentration

Cmax

concentration, descriptive

Secondary/protocol endpoint

tmax, time to maximum concentration

Tmax

concentration, descriptive

Secondary/protocol endpoint

t½, terminal half-life

Half-life

descriptive

Secondary/protocol endpoint

Adverse events

Treatment-emergent AEs (any)

descriptive, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.