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

What Was Tested

In this phase 1 trial, researchers set out to test Liraglutide.

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.

It had four arms (groups): Mild (experimental), Moderate (experimental), Severe (experimental) and Normal (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 24 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: 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).

The full record lists 3 inclusion and 10 exclusion criteria; among the exclusions: known or suspected allergy to trial product or related products; liver transplanted subjects; cardiac problems.

How the Study Was Run

The set-up was non-randomized, parallel-group and open-label.

The Liraglutide group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Liraglutide study: the participants and staff both knew the treatment.

It started in 2006-03 with completion listed for 2006-06.

It ran at 1 site in Poland.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the Curve (0-infinity).

It also tracked 5 secondary outcomes, for example Area under the Curve (0-t), Cmax, maximum concentration, tmax, time to maximum concentration, t½, terminal half-life and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Liraglutide in 24 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Liraglutide compound page, all human trials.