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BASIC2

Active not recruitingPhase 3

Brain Activation and Satiety in Children 2

Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children

Lead sponsor

Seattle Children's Hospital

Assets

Exenatide / GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight

Key I/E criterion

•Age 10-12

Primary endpoint

•BMI SDS, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04520490

Org study IDSTUDY00001984

Timeline

Milestones

Study first posted2020-08-20actual

Study start2021-01-28actual

Primary completion2025-08-21actual

Last update posted2026-01-05actual

Study completion2026-02-12estimated

Assets

Investigational agents

Exenatide GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age10 Years

Maximum age12 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•10-12 years of age

•Male or female

•Ability and willingness to participate in study visits including fMRI scans, blood draws, and weekly injections;

•Parent willing to provide informed written consent and child willing to provide written assent;

•Child has BMI z-score >95th percentile. for age and sex;

•One parent that is obese or overweight (BMI >27 kg/m2); willingness of 1 parent (does not have to be the parent with obesity) to engage in weekly family-based weight control treatment delivered in English.

Exclusion criteria

•History of acute or chronic serious medical conditions;

•known diabetes mellitus or recent (6 mo.) history of anemia;

•Presence of any implanted metal or metal devices, including ferro-metallic surgical clips or orthodontic braces;

•Claustrophobia;

•Documented cognitive disorder, disruptive behavior, inability to participate in group sessions;

•Current use of medications known to alter appetite, body weight, or brain response

•Food intolerance to test meal (macaroni and cheese) or vegetarianism/veganism or severe food allergies.

•Known renal impairment (GFR<60 ml/min/1.73m2)

•History of gastroparesis, pancreatitis or gallstones (unless status post cholecystectomy);

•Family history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma;

•Known elevated calcitonin level at phone screening or increased measured calcitonin level at study visits;

•Untreated thyroid disorder or adrenal insufficiency;

•Use of weight loss medications (child participant) within 3 months of screening visit.

•Participating parent is pregnant

Endpoints (5)

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.

Coverage by outcome category

Weight & body composition

Glycemic / diabetes

Other clinical outcomes

Weight & body composition

3 endpoints

Primary/protocol endpoint

Change of BMI z-score

Time frame:Change from drug treatment randomization at week 8 of family-based behavioral treatment (FBT) to end of combined intervention (FBT + drug) at week 24 of FBT

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

BMI z-score

Time frame:Up to 12-months after ending treatment

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Body composition

Time frame:Change from Baseline to post-Family Based Behavioral Treatment at week 24 and post drug-treatment at week 32

Total fat mass

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Indices of metabolic syndrome

Time frame:Change from Baseline to post-Family Based Behavioral Treatment at week 24

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint/low confidence

Meal induced chances in brain activation to visual food cues

Time frame:Change from Baseline to post-Family Based Behavioral Treatment at week 24

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.