Clinical trial

Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity

Opening soon · Phase 3 · 1 countries · Registry ID NCT07021937

Opening soonPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age12 Years to 45 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity/Therapy

Full registry 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

Treatments and study arms

Semaglutide 1.7mg subcutaneous

Drug

Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment

Placebo

Drug

Placebo saline solution subcutaneous

Primary outcomes

blood oxygen-level dependent signalFrom enrollment to the end of trial at 32 weeks

measured via resting-state functional magnetic resonance imaging

meal kilocalories (kcal)From enrollment to the end of trial at 32 weeks

Measured as kcal consumed from standardized ad libitum meal

visual analogue scale (VAS) score for hungerFrom enrollment to the end of trial at 32 weeks

pre- and post-meal hunger measured on a 100mm VAS

visual analogue scale (VAS) for desire to eatFrom enrollment to end of trial at 32 weeks

pre- and post-meal desire to eat measured on a 100mm VAS

visual analogue scale (VAS) score for fullnessFrom enrollment to end of trial at 32 weeks

pre- and post-meal feeling of fullness measured on a 100mm VAS

visual analogue scale (VAS) score for amount participant feels they can eatFrom enrollment to end of trial at 32 weeks

pre- and post-meal of amount participant feels they can eat measured on a 100mm VAS

Study locations

1 locations were listed when this page was built. The first 40 are shown.

University of Colorado Anschutz Medical Campus🇺🇸 Aurora, Colorado, United States

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Allison Shapiro, PhD, MPHContact

Email · Call 303-724-3733

Allison Shapiro, PhD, MPHPrincipal Investigator