Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide for fat loss, obesity & body recomposition.

Long-term weight loss maintenance is seldom achieved by individuals with obesity owing to numerous biological adaptations involving appetite, satiety, and energy expenditure in the post- weight loss setting.

Adolescents with severe obesity are not immune to the vexing issue of weight regain.

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

The registry classes the interventions as drug.

Who Took Part

100 actual participants took part.

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

Healthy volunteers could join, not only people with the condition.

Examples of who could join: BMI ≥1.2 times the 95th percentile (based on sex and age) or BMI ≥35 kg/m2. 12-17 years old.

The full record lists 2 inclusion and 27 exclusion criteria; among the exclusions: type 1 or 2 diabetes mellitus; previous (within 6 months) or current use of medication(s) prescribed primarily for weight loss (refer to appendix material for comprehensive list); previous bariatric surgery.

How the Study Was Run

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

The fat loss, obesity & body recomposition participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Exenatide.

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

It started in 2015-12 with completion listed for 2020-08-14.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Body Mass Index (time frame: 52 weeks).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 100 people with fat loss, obesity & body recomposition.

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.