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NCT Number: NCT07021937

Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity

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.

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Key information

Conditions

Obesity/therapy Behavior Behavior, Animal Body Weight Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

12 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location contact

Allison Shapiro, PhD, MPH

CONTACT

[email protected]

303-724-3733

Allison Shapiro, PhD, MPH

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semaglutide 1.7mg subcutaneous

Drug

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

Other names: SEMA

Placebo

Drug

Placebo saline solution subcutaneous

Primary outcomes

  1. blood oxygen-level dependent signal

    Time frame: From enrollment to the end of trial at 32 weeks

    measured via resting-state functional magnetic resonance imaging

  2. meal kilocalories (kcal)

    Time frame: From enrollment to the end of trial at 32 weeks

    Measured as kcal consumed from standardized ad libitum meal

  3. visual analogue scale (VAS) score for hunger

    Time frame: From enrollment to the end of trial at 32 weeks

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

  4. visual analogue scale (VAS) for desire to eat

    Time frame: From enrollment to end of trial at 32 weeks

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

  5. visual analogue scale (VAS) score for fullness

    Time frame: From enrollment to end of trial at 32 weeks

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

  6. visual analogue scale (VAS) score for amount participant feels they can eat

    Time frame: From 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 contacts

Contact information is provided by the study sponsor or research team.

Allison Shapiro, PhD, MPH

CONTACT

[email protected]

3037241150

Sean Nilan

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • The Metis Foundation
  • University of Minnesota

Registry information

Official study title

Investigating Brain PLASTICity and GLP-1 Receptor Agonists in the Treatment of Obesity: The PLASTIC Trial

Acronym: PLASTIC

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 15, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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