Pediatric ObesityBOLDNCT07911046
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
An observational study of Pediatric Obesity and Obesity, run by Erin Mauney at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Pediatric Obesity, Obesity
- What is being tested?
- Semaglutide
- Type of treatment
- Injection or infusion
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2027to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Tufts Medical Center
Boston, Massachusetts, 02111
Erin Mauney, MD, 617-636-5000, HealthyKidsLab@tuftsmedicalcenter.org
About this study
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.
Read the detailed description
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.
- Conditions
- Pediatric Obesity, Obesity
- Being tested
- Semaglutide
- Keywords
- semaglutide, GLP-1 receptor agonist, adolescent, functional MRI, resting-state functional connectivity, reward, interoception, appetite, weight loss, brain development, ABCD Study
- Medical subject headings
- Pediatric Obesity, Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents initiating semaglutide | 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. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startMar 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erin Mauney
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erin Mauney, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911046
- Sponsor's protocol ID
- STUDY00007571
- Acronym
- BOLD
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
- ClinicalTrials.gov ID
- NCT07911046
- Acronym / sponsor ID
- BOLD / STUDY00007571
- Conditions
- Pediatric Obesity, Obesity
- Keywords
- semaglutide, GLP-1 receptor agonist, adolescent, functional MRI, resting-state functional connectivity, reward, interoception, appetite
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Erin MauneyUniversity, hospital or other
- Study start
- Mar 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents initiating semaglutide | – | Drug: SemaglutideAdolescents 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. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideWeekly 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. | Drug | Adolescents initiating semaglutide |
Primary outcome
Change in resting-state functional connectivity in reward and default-mode networks
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
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.
5 secondary outcomes
Change in brain structure (hypothalamic and reward-region morphometry)
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Change in fluid cognition (NIH Toolbox Cognition Battery)
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Change in eating behavior and food-related reward
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Change in interoceptive awareness (MAIA-2)
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Change in blood- and saliva-based biomarkers
Time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Obesity and Obesity, run by Erin Mauney at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erin Mauney, MD ((617) 636-3266, erin.mauney@tuftsmedicalenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting-state functional connectivity in reward and default-mode networks (time frame: Baseline (pre-initiation) and approximately 6 months after semaglutide initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.