Double-blinded, 6 Months Study With Bydureon® or Placebo in Adolescents With Obesity to Explore Changes in BMI

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

The reason behind these alarming figures is mostly a changing environment with a more sedative lifestyle and supply of excess food.

It had two arms (groups): Bydureon (active comparator) and Placebo (placebo comparator).

S.c. once Weekly.

S.c. once Weekly.

The registry classes the interventions as behavioral and drug.

Who Took Part

Enrollment: 44 actual participants took part.

It was open to people of any sex aged from 10 years up to 18 years.

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

Examples of who could join: Signed informed consent prior to any study-specific procedures. Males or females of age 10-18 years and 5 months. Obesity (BMI SDS \> 2.0 or age-adapted BMI \> 30 kg/m2), according to WHO. Intrauterine device (IUD). Intrauterine hormone-releasing system (IUS).

The full record lists 16 inclusion and 24 exclusion criteria; among the exclusions: known syndromal obesity, such as prader-willi syndrome, laurence-moon syndrome or bardet-biedl syndrome; pregnancy or lactation; indigestion-causing diseases.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

The Exenatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Exenatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2015-09 with completion listed for 2016-09.

It ran at 2 sites in Austria (1) and Sweden (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): BMI SDS (Body Mass Index Standard Deviation Score) (time frame: 6 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 44 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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