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

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Liraglutide

Criteria

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