A Randomised, Double-blind, Placebo-controlled Trial to Assess Safety, Tolerability and Pharmacokinetics of Liraglutide in Obese Adolescent Subjects Aged 12 to 17 Years

What Was Tested

This registered phase 1 trial tested Liraglutide.

This trial is conducted in Europe.

It had two arms (groups): Liraglutide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 21 actual participants took part.

It was open to people of any sex aged from 12 years up to 17 years.

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

Examples of who could join: Subjects with Tanner stage 2-5 pubertal development at time of randomisation.

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: subjects with confirmed diagnosis of bulimia; subjects with tanner stage 1 development (prepubertal); diagnosis of type 1 or type 2 diabetes mellitus as judged by the investigator.

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.

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 2013-02 with completion listed for 2014-05.

It ran at 1 site in Germany.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of treatment emergent adverse events (TEAEs).

It also tracked 6 secondary outcomes, for example Incidence of liraglutide antibody, At steady-state: model-derived t½ (terminal half-life), At steady-state: model-derived CL/F (apparent clearance) and At steady-state: model-derived V/F (apparent volume of distribution).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Liraglutide in 21 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.