Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity (PLASTIC)

June 6, 2025 updated by: Allison Shapiro, University of Colorado, Denver

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
        • Contact:
        • Principal Investigator:
          • Allison Shapiro, PhD, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.)
Drug: Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Other Names:
  • SEMA
Experimental: 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
Drug: Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Other Names:
  • SEMA
Drug: Placebo
Placebo saline solution subcutaneous
Experimental: 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.)
Drug: Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Other Names:
  • SEMA
Experimental: 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
Drug: Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Other Names:
  • SEMA
Drug: Placebo
Placebo saline solution subcutaneous
Active Comparator: Adult - Continuous Treatment
Adults defined as 30-45 y/o who will receive 32 weeks of semaglutide (s.c.)
Drug: Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Other Names:
  • SEMA
Active Comparator: 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
Drug: Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Other Names:
  • SEMA
Drug: Placebo
Placebo saline solution subcutaneous

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the end of trial at 32 weeks
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
From enrollment to the end of trial at 32 weeks
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
From enrollment to the end of trial at 32 weeks
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
From enrollment to the end of trial at 32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

University of Minnesota
The Metis Foundation

Investigators

  • Principal Investigator: Allison Shapiro, PhD, MPH, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

April 30, 2031

Study Completion (Estimated)

April 30, 2031

Study Registration Dates

First Submitted

June 3, 2025

First Submitted That Met QC Criteria

June 6, 2025

First Posted (Actual)

June 15, 2025

Study Record Updates

Last Update Posted (Actual)

June 15, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pending (ICTR award)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Pending consent authorization by participants

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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