Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity

NCT ID: NCT07021937

Last Updated: 2025-06-15

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-01

Study Completion Date

2031-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity/Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
study statistician

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.)

Group Type EXPERIMENTAL

Semaglutide 1.7mg subcutaneous

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Semaglutide 1.7mg subcutaneous

Intervention Type DRUG

Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment

Placebo

Intervention Type DRUG

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.)

Group Type EXPERIMENTAL

Semaglutide 1.7mg subcutaneous

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Semaglutide 1.7mg subcutaneous

Intervention Type DRUG

Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment

Placebo

Intervention Type DRUG

Placebo saline solution subcutaneous

Adult - Continuous Treatment

Adults defined as 30-45 y/o who will receive 32 weeks of semaglutide (s.c.)

Group Type ACTIVE_COMPARATOR

Semaglutide 1.7mg subcutaneous

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Semaglutide 1.7mg subcutaneous

Intervention Type DRUG

Semaglutide subcutaneous max dose of 1.7mg over 24 or 32 weeks of active treatment

Placebo

Intervention Type DRUG

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

Intervention Type DRUG

Placebo

Placebo saline solution subcutaneous

Intervention Type DRUG

Other Intervention Names

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SEMA

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role collaborator

The Metis Foundation

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Allison Shapiro

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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United States

Central Contacts

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Allison Shapiro, PhD, MPH

Role: CONTACT

3037241150

Facility Contacts

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Allison Shapiro, PhD, MPH

Role: primary

3037243733

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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