Exenatide in Extreme Pediatric Obesity

What Was Tested

This registered phase 2 trial tested Exenatide.

Few drug therapies for weight loss have been evaluated in adolescents.

It had two arms (groups): Exenatide, then Open-Label Exenatide (experimental) and Placebo, then Open Label Exenatide (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

For the initial three-month phase, participants will be equally (by site) and randomly assigned to one of two groups: 1) exenatide plus lifestyle modification, or 2) placebo plus lifestyle modification.

Following baseline testing, subjects will be randomly assigned to study group.

Participants will return at one-month for titration and assessment of safety (blood draw and adverse event assessment) and injection/lifestyle modification compliance and at three-months for reassessment of baseline variables and injection/lifestyle modification compliance and allocation to study drug for the three-month open-label extension.

Participants will return at four-months for assessment of safety (blood draw and adverse event assessment) and injection/lifestyle modification compliance and at six-months for reassessment of baseline variables and injection/lifestyle modification compliance.

Who Took Part

26 actual participants took part.

It was open to people of any sex aged from 12 years up to 19 years.

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

Examples of who could join: Body mass index \> or = 1.2 times the 95th percentile (based on gender and age) or Body mass index \> or = 35 kg/m2. 12-19 years old.

The full record lists 2 inclusion and 15 exclusion criteria; among the exclusions: type 1 or 2 diabetes mellitus; previous (within 3-months) or current use of weight loss medication (patients may undergo washout); previous bariatric surgery.

How the Study Was Run

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

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

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

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 2010-10 with completion listed for 2012-05.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change From Baseline in Body Mass Index at 3-months (time frame: Baseline and 3-months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 26 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 Exenatide compound page, all human trials.