Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity
ConditionObesity/Therapy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-45
SponsorUniversity of Colorado, Denver
About this trial
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
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide 1.7mg subcutaneous
DrugSemaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Placebo
DrugPlacebo saline solution subcutaneous
Treatment groups
120 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Pubertal Adolescent - Continuous TreatmentExperimental treatment 1 intervention
Group B: Pubertal Adolescent - Early Treatment CessationExperimental treatment 2 interventions
Group C: Post-Pubertal Adolescent - Continuous TreatmentExperimental treatment 1 intervention
Group D: Post-Pubertal Adolescent - Early Treatment CessationExperimental treatment 2 interventions
Group E: Adult - Continuous TreatmentActive comparator 1 intervention
Group F: Adult - Early Treatment CessationActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
blood oxygen-level dependent signal
measured via resting-state functional magnetic resonance imaging
Time frame
From enrollment to the end of trial at 32 weeks2
meal kilocalories (kcal)
Measured as kcal consumed from standardized ad libitum meal
Time frame
From enrollment to the end of trial at 32 weeks3
visual analogue scale (VAS) score for hunger
pre- and post-meal hunger measured on a 100mm VAS
Time frame
From enrollment to the end of trial at 32 weeks4
visual analogue scale (VAS) for desire to eat
pre- and post-meal desire to eat measured on a 100mm VAS
Time frame
From enrollment to end of trial at 32 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
University of Minnesota
Collaborator
The Metis Foundation
Collaborator
Source ClinicalTrials.gov
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