Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects

What Was Tested

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

This trial is conducted in the United States of America (USA).

It had five arms (groups): one (experimental), one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 31 actual participants took part.

It was open to men only aged from 18 years up to 55 years.

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

Examples of who could join: Body mass index (BMI) between 20 and 35 kg/m\^2 (both inclusive) with a body weight of at least 60 kg. Apart from being obese (BMI above 30 kg/m\^2) the subject has to be considered generally healthy.

The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: prescription medicine and non-prescription medicine with few exceptions; current and prior history of alcohol or drug abuse; current smoking of more than 5 cigarettes per day.

How the Study Was Run

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

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2011-10 with completion listed for 2012-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Treatment Emergent Adverse Events (TEAEs) (time frame: Day 0 and up to 21 days after treatment).

It also tracked 6 secondary outcomes, for example Area Under the Plasma Concentration Curve in the Period From the Time of Liraglutide-depot Administration to Infinity.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 31 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Liraglutide compound page, all human trials.