Obesity/TherapyPhase 3PLASTICNCT07021937
Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity
A Phase 3 study testing Semaglutide 1.7mg subcutaneous in people with Obesity/Therapy, run by University of Colorado, Denver at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Obesity/Therapy
- What is being tested?
- Semaglutide 1.7mg subcutaneous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jun 2026to 30 Apr 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sean Nilan contact
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Allison Shapiro, PhD, MPH, 303-724-3733, allison.shapiro@cuanschutz.edu
Allison Shapiro, PhD, MPH
About this study
Official title: 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.
- Conditions
- Obesity/Therapy
- Being tested
- Semaglutide 1.7mg subcutaneous, Placebo
- Keywords
- adolescent, adult, brain function, glucagon-like peptide-1 receptor agonists, eating behaviors, appetite sensations
- Medical subject headings
- Obesity, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 1.7mg subcutaneousDrug
Also called SEMA
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
PlaceboDrug
Placebo saline solution subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Pubertal Adolescent - Continuous Treatment | Experimental | Pubertal adolescents defined as Tanner stage 2-4 and/or 12-15 y/o who will receive 32 weeks of semaglutide (s.c.) Receives: Drug: Semaglutide 1.7mg subcutaneous |
| Pubertal Adolescent - Early Treatment Cessation | Experimental | 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 Receives: Drug: Semaglutide 1.7mg subcutaneous; Drug: Placebo |
| Post-Pubertal Adolescent - Continuous Treatment | Experimental | Post-pubertal adolescents defined as Tanner stage 5 and/or 16-18 y/o who will receive 32 weeks of semaglutide (s.c.) Receives: Drug: Semaglutide 1.7mg subcutaneous |
| Post-Pubertal Adolescent - Early Treatment Cessation | Experimental | 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 Receives: Drug: Semaglutide 1.7mg subcutaneous; Drug: Placebo |
| Adult - Continuous Treatment | Active comparator | Adults defined as 30-45 y/o who will receive 32 weeks of semaglutide (s.c.) Receives: Drug: Semaglutide 1.7mg subcutaneous |
| Adult - Early Treatment Cessation | Active comparator | Adults defined as 30-45 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo Receives: Drug: Semaglutide 1.7mg subcutaneous; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood oxygen-level dependent signal
measured via resting-state functional magnetic resonance imaging
Measured: From enrollment to the end of trial at 32 weeks
meal kilocalories (kcal)
Measured as kcal consumed from standardized ad libitum meal
Measured: From enrollment to the end of trial at 32 weeks
visual analogue scale (VAS) score for hunger
pre- and post-meal hunger measured on a 100mm VAS
Measured: From enrollment to the end of trial at 32 weeks
visual analogue scale (VAS) for desire to eat
pre- and post-meal desire to eat measured on a 100mm VAS
Measured: From enrollment to end of trial at 32 weeks
visual analogue scale (VAS) score for fullness
pre- and post-meal feeling of fullness measured on a 100mm VAS
Measured: From enrollment to end of trial at 32 weeks
visual analogue scale (VAS) score for amount participant feels they can eat
pre- and post-meal of amount participant feels they can eat measured on a 100mm VAS
Measured: From enrollment to end of trial at 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start15 Jun 2026 (estimated)
- Primary completion30 Apr 2031 (estimated)
- Study completion30 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity/TherapyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, The Metis Foundation
- Responsible party
- Sponsor
- Investigators
- Allison Shapiro, PhD, MPH, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021937
- Sponsor's protocol ID
- Pending
- Other IDs
- Pending
- Acronym
- PLASTIC
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pending consent authorization by participants
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Brain PLASTICity and GLP-1 Receptor Agonists in the Treatment of Obesity: The PLASTIC Trial
- ClinicalTrials.gov ID
- NCT07021937
- Acronym / sponsor ID
- PLASTIC / Pending
- Conditions
- Obesity/Therapy
- Keywords
- adolescent, adult, brain function, glucagon-like peptide-1 receptor agonists, eating behaviors, appetite sensations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- University of Minnesota, The Metis Foundation
- Study start
- 15 Jun 2026 (estimated)
- Primary completion
- 30 Apr 2031 (estimated)
- Study completion
- 30 Apr 2031 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Pubertal Adolescent - Continuous Treatment | Experimental | Drug: Semaglutide 1.7mg subcutaneousPubertal adolescents defined as Tanner stage 2-4 and/or 12-15 y/o who will receive 32 weeks of semaglutide (s.c.) |
| Pubertal Adolescent - Early Treatment Cessation | Experimental | Drug: Semaglutide 1.7mg subcutaneous, Drug: PlaceboPubertal 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 |
| Post-Pubertal Adolescent - Continuous Treatment | Experimental | Drug: Semaglutide 1.7mg subcutaneousPost-pubertal adolescents defined as Tanner stage 5 and/or 16-18 y/o who will receive 32 weeks of semaglutide (s.c.) |
| Post-Pubertal Adolescent - Early Treatment Cessation | Experimental | Drug: Semaglutide 1.7mg subcutaneous, Drug: PlaceboPost-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 |
| Adult - Continuous Treatment | Active comparator | Drug: Semaglutide 1.7mg subcutaneousAdults defined as 30-45 y/o who will receive 32 weeks of semaglutide (s.c.) |
| Adult - Early Treatment Cessation | Active comparator | Drug: Semaglutide 1.7mg subcutaneous, Drug: PlaceboAdults defined as 30-45 y/o who will receive 24 weeks of semaglutide (s.c.) followed by 8 weeks of placebo |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 1.7mg subcutaneousAlso: SEMASemaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment | Drug | Adult - Continuous Treatment, Adult - Early Treatment Cessation, Post-Pubertal Adolescent - Continuous Treatment, Post-Pubertal Adolescent - Early Treatment Cessation, Pubertal Adolescent - Continuous Treatment, Pubertal Adolescent - Early Treatment Cessation |
| PlaceboPlacebo saline solution subcutaneous | Drug | Adult - Early Treatment Cessation, Post-Pubertal Adolescent - Early Treatment Cessation, Pubertal Adolescent - Early Treatment Cessation |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No. Pending consent authorization by participants
Related trials for Obesity/Therapy
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
RecruitingPhase 3
A Study to Learn About Safety and Effects of Once-monthly Treatment With Berobenatide in Adults With Obesity Disease in Japan (VESPER-JM)
Obesity
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
RecruitingObservational study
Two-Year Weight Loss With GLP-1 Medications Compared With Sleeve Gastrectomy in Adults With Obesity
Obesity & Overweight
Active, not recruiting
Family Functioning in Obesity Treatment for Mexican Americans
Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sean Nilan contact
Allison Shapiro, PhD, MPH principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide 1.7mg subcutaneous in people with Obesity/Therapy, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allison Shapiro, PhD, MPH (3037241150, allison.shapiro@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blood oxygen-level dependent signal (time frame: From enrollment to the end of trial at 32 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.