An observational study in Pediatric Obesity and Obesity, sponsored by Erin Mauney. Not yet recruiting at 1 site in United States. Open to participants aged 12 Years to 15 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by Erin Mauney · Observational
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.
Glucagon-like peptide-1 (GLP-1) receptor agonists such as semaglutide are increasingly prescribed to adolescents with obesity, but their effects on the developing adolescent brain are not well understood. This observational pilot study uses a within-subject, pre-post design to characterize the neurobiological, cognitive, behavioral, and biological changes associated with approximately 6 months of clinically prescribed semaglutide in adolescents.
Participants are adolescents 12 to 15 years old with obesity whose treating physician has independently decided to initiate weekly subcutaneous semaglutide. Participants are enrolled before medication initiation and complete a baseline visit and a follow-up visit approximately 6 months later. The study team does not influence prescribing or dosing.
Specific Aims:
Aim 1 (Neuroimaging): Characterize within-subject changes in resting-state functional connectivity and brain structure (including hypothalamic and reward-network measures) before and after approximately 6 months of treatment, and compare these measures with normative data from the ABCD Study.
Aim 2 (Neurobehavioral and biological markers): Measure changes in cognition, mood, interoceptive awareness, eating behavior, food-related reward and "food noise," and a panel of salivary and blood-based biomarkers (including adipokines, inflammatory markers, and neurotrophic and appetite-regulating factors), with biobanking for future analyses.
Aim 3 (Qualitative): Characterize adolescents' lived experience of treatment through a semi-structured interview at follow-up.
Assessments at each visit include 3T structural MRI, resting-state functional MRI, and dedicated hypothalamic (sella) imaging; a neurobehavioral and interoceptive battery administered to the adolescent along with selected parent-report measures; anthropometrics; and saliva and fasting blood collection for biomarker measurement and biobanking. Routine-type laboratory measures (e.g., HbA1c, ALT, lipids) are assayed on the research blood sample.
Target enrollment is approximately 8 evaluable participants, with over-enrollment (up to approximately 12) to account for attrition; participants who withdraw before the follow-up visit may be replaced. Total participation is approximately 6 to 7 months. This study is funded by a Natalie V. Zucker Research Center Award at Tufts University School of Medicine.
1,127 studies on the registry are indexed under Pediatric Obesity; 188 are open to participants now.
This study's planned enrollment of 12 is below the median of 180 across 234 observational studies indexed under Pediatric Obesity.
Browse Pediatric Obesity studies →This is the only study on the registry with Erin Mauney as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adolescents aged 12 to 15 years with obesity who are initiating clinically prescribed weekly subcutaneous semaglutide as part of routine clinical care, recruited from pediatric weight-management and primary care practices in Massachusetts. The enrollment target is approximately 8 evaluable participants, with over-enrollment (up to approximately 12) to account for attrition.
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Exclusion Criteria:
Adolescents aged 12 to 15 years with obesity (body mass index at or above the 95th percentile for age and sex) who are starting clinically prescribed weekly subcutaneous semaglutide as part of routine clinical care. Participants are assessed before medication initiation and again after approximately 6 months of treatment. The study does not assign, provide, or modify the medication.
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.
Change in resting-state functional connectivity in reward and default-mode networks
Within-subject change in resting-state functional connectivity within and between reward, default-mode, and salience networks, derived from 3T resting-state functional MRI and analyzed as network connectivity and graph metrics, from baseline to approximately 6 months of treatment. Measures are interpreted relative to normative data from the ABCD Study.
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Change in brain structure (hypothalamic and reward-region morphometry)
Within-subject change in brain structure derived from 3T structural MRI, including hypothalamic and reward-related region volume and morphometry, from baseline to approximately 6 months of treatment.
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Change in fluid cognition (NIH Toolbox Cognition Battery)
Within-subject change in fluid cognition measured with the NIH Toolbox Cognition Battery (fluid subset), from baseline to approximately 6 months of treatment.
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Change in eating behavior and food-related reward
Within-subject change in eating behavior, food-related reward, and food preoccupation ("food noise") measured by validated self-report instruments, from baseline to approximately 6 months of treatment.
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Change in interoceptive awareness (MAIA-2)
Within-subject change in interoceptive awareness measured with the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2), from baseline to approximately 6 months of treatment.
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Change in blood- and saliva-based biomarkers
Within-subject change in a panel of blood- and saliva-based biomarkers, including adipokines (e.g., leptin, adiponectin), inflammatory markers, neurotrophic factors, and appetite-regulating hormones, from baseline to approximately 6 months of treatment.
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Plan to share: No
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Start is estimated for Mar 2027; primary completion for Dec 2028, 21 months later.
Of 94 non-industry observational studies under Pediatric Obesity, half reached primary completion within 52 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 125. This study's planned 21 months is below that.
Counting every sponsor, half of 96 studies reached it within 52 months; a quarter within 21 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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