Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide in Healthy Japanese Volunteers

What Was Tested

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

This trial is conducted in Japan.

The aim of this trial is to assess the safety and tolerability of NNC 90-1170 (liraglutide) in healthy Japanese male subjects.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 32 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 1 inclusion and 11 exclusion criteria; among the exclusions: clinically relevant abnormalities of physical examination, laboratory values, vital signs or ecg findings at the screening, as judged by the investigator or sub-investigator; blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90-150 mmhg systolic or 40-90 mmhg diastolic; heart rate in supine position at the screening, after resting for 5 min, outside the range 40-100 beats/min.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2002-12 with completion listed for 2003-03.

It ran at 1 site in Japan.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Body weight. Vital signs (Blood pressure). Vital signs (Pulse rate).

It also tracked 7 secondary outcomes, for example Area under the plasma NNC 90-1170 curve, Maximum plasma NNC 90-1170 concentration, Cmax, Time to maximum plasma NNC 90-1170 concentration, tmax, Terminal elimination half-life, t1/2, 24-hour glucose profile in serum and 24-hour insulin profile in serum.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 32 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.