Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide 1.7mg subcutaneous, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity/Therapy. Basic parameters: 12 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Investigating Brain PLASTICity and GLP-1 Receptor Agonists in the Treatment of Obesity: The PLASTIC Trial
Overview
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.
Interventions
- Drug Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment - Drug Placebo
Placebo saline solution subcutaneous
Primary outcome measures
- blood oxygen-level dependent signal [Time frame: From enrollment to the end of trial at 32 weeks]
- meal kilocalories (kcal) [Time frame: From enrollment to the end of trial at 32 weeks]
- visual analogue scale (VAS) score for hunger [Time frame: From enrollment to the end of trial at 32 weeks]
- visual analogue scale (VAS) for desire to eat [Time frame: From enrollment to end of trial at 32 weeks]
- visual analogue scale (VAS) score for fullness [Time frame: From enrollment to end of trial at 32 weeks]
- visual analogue scale (VAS) score for amount participant feels they can eat [Time frame: From enrollment to end of trial at 32 weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Colorado Anschutz Medical Campus — Aurora
Identifiers
NCT: NCT07021937 · Pending · Pending