Safety and Tolerability of Liraglutide in Healthy Male Volunteers

What Was Tested

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

This trial is conducted in Europe.

It had two arms (groups): NNC 90-1170 (liraglutide) (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 34 actual participants took part.

It was open to men only aged from 18 years up to 45 years.

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

Examples of who could join: Male subjects of any ethnic origin. Good general health based on medical history, physical and laboratory examinations, incl. ECG (electrocardiogram). Body mass index within the range 20-27 kg/m\^2, inclusive.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: history of alcoholism or drug addiction; positive results in the plasma urine screens for illicit drug; alcohol intake within 48 hours of visit; hepatitis b surface antigen (hbsag), hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and investigator.

It started in 1999-03 with completion listed for 1999-12.

It ran at 1 site in United Kingdom.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): AUC (area under the curve).

It also tracked 3 secondary outcomes, for example Cmax, maximum concentration, tmax, time to maximum concentration and t½, terminal half-life.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 34 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.