Safety and Tolerability of Liraglutide in Healthy Japanese Male Volunteers

What Was Tested

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

This trial is conducted in Japan.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

24 actual participants took part.

It was open to men only aged from 20 years up to 45 years.

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

Examples of who could join: Healthy Japanese subjects. BMI (Body Mass Index) between 18.0-27.0 kg/m\^2 inclusive.

The full record lists 2 inclusion and 8 exclusion criteria; among the exclusions: hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive; known or suspected allergy to trial product or related products; history of drug or alcohol abuse.

How the Study Was Run

Design: randomized, crossover and double-blind.

Random assignment meant chance, not the researchers, decided who got Liraglutide and who got the comparison, which limits bias.

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

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 2006-01 with completion listed for 2006-04.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Adverse events. Body weight. Antibody against liraglutide.

It also tracked 7 secondary outcomes, for example Area under the plasma liraglutide concentration curve, Cmax, maximum concentration, tmax, time to reach Cmax, Terminal elimination rate constant, t½, terminal elimination half-life and 24-hour profiles of plasma glucose.

What This Means in Plain Language

Put simply, this is a phase 1, 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.