Metabolism and Excretion of Liraglutide in Healthy Male Volunteers

What Was Tested

This registered phase 1 trial tested Liraglutide.

This trial is conducted in Europe.

The aim of this trial is characterise the metabolic profile of liraglutide in plasma, urine, and faeces after a single injection of \[3H\]-liraglutide.

It had 1 arm (groups): Liraglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 7 planned participants were the target.

It was open to men only aged from 30 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Good general health as judged by the Investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs, and blood and urinary laboratory assessments. BMI (Boday Mass Index) of 20.0-27.0 kg/m\^2, both inclusive.

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: impaired renal function; active hepatitis b or active hepatitis c; positive human immunodeficiency virus (hiv) antibodies.

How the Study Was Run

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

Being open-label, the Liraglutide study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-11 with completion listed for 2006-12.

It ran at 1 site in Netherlands.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Profile and identity of the major metabolites of tritium labelled liraglutide in plasma, urine, and faeces. Total recovery of tritium, [3H]-liraglutide and metabolites in urine and faeces.

It also tracked 6 secondary outcomes, for example Area under the curve, Cmax, maximum concentration, tmax, time to reach Cmax, t½, terminal half-life, The distribution of [3H]-liraglutide in whole blood versus plasma and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Liraglutide in 7 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.