Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers

What Was Tested

This registered phase 1 trial tested Liraglutide.

This trial is conducted in Japan.

The aim of this trial is to assess the safety and tolerability of liraglutide in healthy Japanese male subjects.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 24 actual participants took part.

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

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

Examples of who could join: Body mass index (BMI) between 18 and 27 kg/m\^2 inclusive.

The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: any clinical laboratory values deviated from the reference range at the laboratory; hepatitis b surface antigen, hepatitis c antibodies or hiv (human immunodeficiency virus) antibodies positive; known or suspected allergy to trial product or related products.

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.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2003-09 with completion listed for 2004-03.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Area under the plasma liraglutide curve.

It also tracked 8 secondary outcomes, for example Cmax, maximum plasma liraglutide concentration, tmax, time to reach Cmax, Terminal phase elimination rate-constant, t½, terminal elimination half life, 24-hour profiles of serum insulin and 24-hour profiles of serum 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.