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NOT YET RECRUITING
NCT07911046

Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity

Sponsor: Erin Mauney

View on ClinicalTrials.gov

Summary

This single-site, prospective observational pilot study examines how clinically prescribed semaglutide is associated with changes in the adolescent brain, cognition, mood, interoception, and metabolic and biological markers. Adolescents 12 to 15 years old with obesity (body mass index at or above the 95th percentile for age and sex), whose own treating physician has independently decided to start weekly subcutaneous semaglutide (Wegovy) as part of routine care, complete multimodal assessments before starting the medication and again after approximately 6 months of treatment. Assessments at each timepoint include 3T structural and resting-state functional MRI, a neurobehavioral and interoceptive battery, and saliva and blood collection for biomarker analysis and biobanking; a semi-structured qualitative interview is conducted at the follow-up visit. The study does not provide, prescribe, or modify the medication-all treatment decisions are made by the participant's own physician. The primary goal is to characterize within-subject changes in resting-state functional connectivity, brain structure, cognition, and eating- and reward-related behavior associated with GLP-1 receptor agonist treatment during adolescence, and to interpret these measures relative to normative neuroimaging and cognitive data from the Adolescent Brain Cognitive Development (ABCD) Study.

Key Details

Gender

All

Age Range

12 Years - 15 Years

Study Type

OBSERVATIONAL

Enrollment

12

Start Date

2027-03

Completion Date

2029-06

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DRUG

Semaglutide

Weekly subcutaneous semaglutide (a GLP-1 receptor agonist), prescribed and managed by the participant's own physician as part of routine clinical care and titrated per the approved pediatric schedule to a maintenance dose of at least 1.7 mg per week. The study observes participants during treatment but does not administer, provide, or modify the medication.

Locations (1)

Tufts Medical Center

Boston, Massachusetts, United States