GLP-1 Therapy for Weight Loss and Improved Glucose Tolerance in Obese Children

What Was Tested

This registered phase 2 trial tested Exenatide for fat loss, obesity & body recomposition.

The prevalence of severely obese children is on the rise.

Behavioral therapies for weight loss are successful in some, but others need more aggressive approaches such as drug therapy.

It had two arms (groups): Exenatide (experimental) and Control (no intervention).

Exenatide.

Control - no intervention.

The registry classes the interventions as drug.

More on the Plan

This will be a randomized, open-label, controlled, crossover clinical trial in 12 patients.

All patients will receive exenatide and undergo the control phase.

Following baseline testing, participants will be randomly assigned to treatment order: therapy (exenatide) or control (lifestyle modification).

Half (n = 6) will receive exenatide first (3-months) then cross over to control (no drug therapy for 3-months).

Who Took Part

Enrollment: 12 actual participants took part.

It was open to people of any sex aged from 8 years up to 19 years.

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

Examples of who could join: Age 8-19 years old. Subject able to give assent, and parent/guardian capable of giving consent on behalf of the child. Body mass index (BMI) ≥ 99th percentile (based on gender and age).

The full record lists 3 inclusion and 11 exclusion criteria; among the exclusions: type 1 or 2 diabetes mellitus; initiation of a new drug therapy within the past 30 days prior to the screening visit; BMI ≥ 55.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

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

In the crossover set-up each of the fat loss, obesity & body recomposition participants took both Exenatide and the comparison in turn, acting as their own control.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2009-05 with completion listed for 2011-02.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Body Mass Index (BMI) (time frame: 3-month).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 12 people with fat loss, obesity & body recomposition.

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 Exenatide compound page, Fat loss, obesity & body recomposition research.