Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity
NCT ID: NCT07021937
Last Updated: 2025-06-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
120 participants
INTERVENTIONAL
2026-05-01
2031-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.)
Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
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
Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Placebo
Placebo saline solution subcutaneous
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.)
Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
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
Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Placebo
Placebo saline solution subcutaneous
Adult - Continuous Treatment
Adults defined as 30-45 y/o who will receive 32 weeks of semaglutide (s.c.)
Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
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
Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Placebo
Placebo saline solution subcutaneous
Interventions
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Semaglutide 1.7mg subcutaneous
Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment
Placebo
Placebo saline solution subcutaneous
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
45 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
The Metis Foundation
OTHER
University of Colorado, Denver
OTHER
Responsible Party
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Allison Shapiro
Assistant Professor
Principal Investigators
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Allison Shapiro, PhD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pending
Identifier Type: OTHER
Identifier Source: secondary_id
Pending
Identifier Type: -
Identifier Source: org_study_id
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