Investigating Brain PLASTICity and GLP-1 Receptor Agonists in the Treatment of Obesity: The PLASTIC Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- blood oxygen-level dependent signal
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
study statistician
Eligibility Criteria
- Ages
- 12 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Adult - Early Treatment Cessation
Adults defined as 30-45 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo
Intervention: Placebo (Drug)
Adult - Continuous Treatment
Adults defined as 30-45 y/o who will receive 32 weeks of semaglutide (s.c.)
Intervention: Semaglutide 1.7mg subcutaneous (Drug)
Adult - Early Treatment Cessation
Adults defined as 30-45 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo
Intervention: Semaglutide 1.7mg subcutaneous (Drug)
Pubertal Adolescent - Continuous Treatment
Pubertal adolescents defined as Tanner stage 2-4 and/or 12-15 y/o who will receive 32 weeks of semaglutide (s.c.)
Intervention: Semaglutide 1.7mg subcutaneous (Drug)
Pubertal Adolescent - Early Treatment Cessation
Pubertal adolescents defined as Tanner stage 2-4 and/or 12-15 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo
Intervention: Semaglutide 1.7mg subcutaneous (Drug)
Pubertal Adolescent - Early Treatment Cessation
Pubertal adolescents defined as Tanner stage 2-4 and/or 12-15 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo
Intervention: Placebo (Drug)
Post-Pubertal Adolescent - Continuous Treatment
Post-pubertal adolescents defined as Tanner stage 5 and/or 16-18 y/o who will receive 32 weeks of semaglutide (s.c.)
Intervention: Semaglutide 1.7mg subcutaneous (Drug)
Post-Pubertal Adolescent - Early Treatment Cessation
Post-pubertal adolescents defined as Tanner stage 5 and/or 16-18 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo
Intervention: Semaglutide 1.7mg subcutaneous (Drug)
Post-Pubertal Adolescent - Early Treatment Cessation
Post-pubertal adolescents defined as Tanner stage 5 and/or 16-18 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
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
meal kilocalories (kcal)
Time Frame: 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 hunger
Time Frame: From 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 eat
Time Frame: From 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 fullness
Time Frame: From 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 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
hypothalamic functional activation
Time Frame: From enrollment to the end of trial at 32 weeks
blood oxygen-level dependent signal via resting-state functional magnetic resonance imaging
hypothalamic functional connectivity
Time Frame: From enrollment to the end of trial at 32 weeks
blood oxygen-level dependent signal via resting-state functional magnetic resonance imaging
ad libitum food intake
Time Frame: From enrollment to the end of trial at 32 weeks
Measured as kcal consumed from standardized ad libitum meal
appetite sensations
Time Frame: From enrollment to the end of trial at 32 weeks
pre- and post-meal hunger, desire to eat, amount feel can eat, and fullness
Secondary Outcomes
No secondary outcomes reported
Investigators
Allison Shapiro
Assistant Professor
University of Colorado, Denver