Brain Activation and Satiety in Children 2

What Was Tested

This registered phase 3 trial tested Exenatide.

It had two arms (groups): Exenatide once weekly extended-release (active comparator) and Matching placebo (placebo comparator).

Weekly subcutaneous injections of placebo for 24 weeks.

The registry classes the interventions as behavioral and drug.

More on the Plan

Using functional and structural magnetic resonance neuroimaging, this study will evaluate brain factors which could undermine treatment responses and long-term obesity intervention outcomes.

Specific Aim 1 will test the effect of adding ExQW to FBT on change in BMI z-score over a total GLP-1RA treatment duration of 24 weeks and a subsequent 1-year observational follow-up period after treatment cessation.

To provide mechanistic insight, Specific Aim 2 will test whether adding GLP-1RA intervention to FBT impacts neural activation by food cues.

Finally, the proposed research will investigate the role of a cellular inflammatory process in the mediobasal hypothalamus-called gliosis-which might contribute to impaired hypothalamic function, attenuated satiety responsiveness, and potentially to worse weight management outcomes.

Who Took Part

63 actual participants took part.

It was open to people of any sex aged from 10 years up to 12 years.

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

Examples of who could join: 10-12 years of age. Male or female. Ability and willingness to participate in study visits including fMRI scans, blood draws, and weekly injections;. Parent willing to provide informed written consent and child willing to provide written assent;. Child has BMI z-score \>95th percentile. for age and sex;.

The full record lists 6 inclusion and 14 exclusion criteria; among the exclusions: history of acute or chronic serious medical conditions;; known diabetes mellitus or recent (6 mo.) history of anemia;; presence of any implanted metal or metal devices, including ferro-metallic surgical clips or orthodontic braces;.

How the Study Was Run

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

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.

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

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2021-01-28 with completion listed for 2025-08-21.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change of BMI z-score.

It also tracked 4 secondary outcomes, for example BMI z-score, Body composition, Indices of metabolic syndrome and Meal induced chances in brain activation to visual food cues.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide in 63 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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