BOLD

Not yet recruiting

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

Lead sponsor

Erin Mauney

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

•Age 12-15

Primary endpoint

•Resting-state functional connectivity in reward and default-mode networks

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07911046

Org study IDSTUDY00007571

Timeline

Milestones

Study first posted2026-11-02actual

Last update posted2026-11-02actual

Study start2027-03estimated (month precision)

Primary completion2028-12estimated (month precision)

Study completion2029-06estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age12 Years

Maximum age15 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

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.

Inclusion criteria

•Adolescents 12 to 15 years old at enrollment

•Obesity, defined as body mass index (BMI) at or above the 95th percentile for age and sex and below 160% of the 95th percentile

•The participant's own treating physician has independently decided to initiate weekly subcutaneous semaglutide (with a planned maintenance dose of at least 1.7 mg per week) as part of routine clinical care

•Able to undergo magnetic resonance imaging (MRI)

•Parent/guardian permission and participant assent

Exclusion criteria

•Any contraindication to MRI (e.g., non-removable implanted metal or electronic device, or fixed metal orthodontic hardware)

•Current or prior use of a GLP-1 receptor agonist, or recent discontinuation

•Pregnancy

•Current treatment with a GnRH analog or gender-affirming hormone therapy

•Any medical, neurological, or developmental condition that, in the investigator's judgment, would prevent completion of study procedures or confound the imaging or cognitive measures

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

6 endpoints

Primary/protocol endpoint/low confidence

Change in resting-state functional connectivity in reward and default-mode networks

Time frame:Baseline (pre-initiation) and approximately 6 months after semaglutide initiation