Clinical trial NCT07021937: Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity
Official title: Investigating Brain PLASTICity and GLP-1 Receptor Agonists in the Treatment of Obesity: The PLASTIC Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Obesity/Therapy
Keywords: adolescent
adult
brain function
glucagon-like peptide-1 receptor agonists
eating behaviors
appetite sensations
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: University of Minnesota
name: The Metis Foundation
First posted: 2025-06-15
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Glucagon-like peptide 1 receptor agonists (GLP-1RA), such as Ozempic and Wegovy, have been rapidly adopted for the treatment of obesity in both youth and adults. However, despite this rapid adoption and the known GLP-1RA mechanism of action for weight loss, which targets brain circuits responsible for appetite and eating behaviors, almost nothing is known about how these drugs affect the brain in youth who are treated for obesity, or how these drugs affect the brain of youth differently from adults. The goal of the current study is to compare youth and adults with obesity who are treated a GLP-1RA and measure potential difference in GLP-1RA associated change in brain function, appetite, and eating behaviors.


Eligibility criteria: Inclusion Criteria:

* English-speaking
* male or female (sex assigned at birth)
* 12-18 y/o with obesity (BMI\>120% of the 95th %ile)
* 30-45 y/o with obesity (BMI\>35 kg/m2)

Exclusion Criteria:

* treated with glucagon-like peptide-1 (GLP-1) agonists (e.g., exenatide, liraglutide, semaglutide, tirzepatide) for weight management in the prior 3 months
* currently taking anti-psychotic medications (anti-depressants accepted)
* diagnosis of type 2 diabetes
* current or lifetime anorexia nervosa or current bulimia nervosa
* head injury resulting in loss of consciousness \>30min
* neurological disorder (e.g., Parkinson's disease) or history of stroke
* any contraindication to receiving a MRI (e.g., orthodontal braces)
* psychological/behavioral dysfunction (e.g., autism spectrum disorder) or physical impairment that would interfere with study procedures, as determined by study physician
* if female, desiring to become pregnant, or currently pregnant or breastfeeding

Primary outcomes:
measure: hypothalamic functional activation
timeFrame: From enrollment to the end of trial at 32 weeks
measure: hypothalamic functional connectivity
timeFrame: From enrollment to the end of trial at 32 weeks
measure: ad libitum food intake
timeFrame: From enrollment to the end of trial at 32 weeks
measure: appetite sensations
timeFrame: From enrollment to the end of trial at 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Allison Shapiro, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: