Childhood ObesityPhase 3BASIC2NCT04520490

Brain Activation and Satiety in Children 2

A Phase 3 study testing Family Based Behavioral Treatment and Exenatide 2 mg [Bydureon] in people with Childhood Obesity, run by Seattle Children's Hospital at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Childhood obesity and related long-term effects are serious public health problems, but not all children with obesity do well in treatment. This study will test a new combination of family-based behavioral treatment (FBT) with a drug intervention using a glucagon-like peptide-1 receptor agonist (GLP-1RA) exenatide… Read more about this study

Who is it for?: Ages 10 to 12 years
Conditions the study is for: Childhood Obesity
What is being tested?: Family Based Behavioral Treatment and Exenatide 2 mg [Bydureon]
Type of treatment: Injection or infusion, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 63 participants
Where: 1 siteUnited States
Study dates: 28 Jan 2021to 12 Feb 2026
Phase: Phase 3
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 10 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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.

Who cannot join

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

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Seattle Children's Hospital
Seattle, Washington, 98105

Other trials in United States

About this study

Official title: Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children

Read the detailed description

Using functional and structural magnetic resonance neuroimaging, this study will evaluate brain factors which could undermine treatment responses and long-term obesity intervention outcomes. Specific Aim 1 will test the effect of adding ExQW to FBT on change in BMI z-score over a total GLP-1RA treatment duration of 24 weeks and a subsequent 1-year observational follow-up period after treatment cessation. To provide mechanistic insight, Specific Aim 2 will test whether adding GLP-1RA intervention to FBT impacts neural activation by food cues. Finally, the proposed research will investigate the role of a cellular inflammatory process in the mediobasal hypothalamus-called gliosis-which might contribute to impaired hypothalamic function, attenuated satiety responsiveness, and potentially to worse weight management outcomes. Specific Aim 3 will test if hypothalamic gliosis is modified by FBT and/or FBT plus GLP-1RA in children and if its extent is related to immediate and/or long-term intervention outcomes.

Study Design: This double-blinded, randomized, placebo-controlled research study uses fMRI to characterize neural responses to a test meal before and at the end of FBT intervention, with vs. without additional GLP-1RA intervention. In addition, it uses structural MRI (sMRI) to test if MBH gliosis is reversible and/or associated with intervention outcomes.

Conditions: Childhood Obesity
Being tested: Family Based Behavioral Treatment, Exenatide 2 mg [Bydureon], Placebo
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Family Based Behavioral TreatmentBehavioural
Children with obesity accompanied by at least one parent or caregiver will attend 24 weekly sessions. Most sessions will be held via video-conference and include 25-30 min. meetings between an interventionist and each child/parent pair to individualize treatment, followed by separate child and parent group meetings lasting 40 - 45 min. A select few sessions will be held in-person between an interventionist and each child/parent pair with no group session. Parents will serve as primary agents of change for their child and for themselves. Training will focus on food and physical activity education, parenting around food and physical activity, and use of behavioral skills (e.g., self-monitoring, environmental control, contingency management). Intervention groups of 8-12 children/families will be initiated every 3-6 mos. in study yrs. 2-3.
Exenatide 2 mg [Bydureon]Drug
Also called Bydureon®
Weekly injections of active drug.
PlaceboDrug
Weekly placebo injections

Study groups in NCT04520490
Study group	Role	What they receive
Exenatide once weekly extended-release	Active comparator	Weekly subcutaneous injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (2mg) for 24 weeks in randomized intervention. Receives: Behavioral: Family Based Behavioral Treatment; Drug: Exenatide 2 mg [Bydureon]
Matching placebo	Placebo comparator	Weekly subcutaneous injections of placebo for 24 weeks. Receives: Behavioral: Family Based Behavioral Treatment; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of BMI z-score
Body mass index (BMI) z-scores will be derived using CDC growth charts, using the LMS method, to allow for comparison of adiposity over time and across children who differ in age and sex.
Measured: 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

Secondary outcomes (4)

BMI z-score
Change of body mass index (BMI) z-scores derived using CDC growth charts, using the LMS method, to allow for comparison of adiposity over time and across children who differ in age and sex.
Measured: Up to 12-months after ending treatment
Body composition
Changes in body composition as assessed using a bioelectrical impedance (BIA)
Measured: Change from Baseline to post-Family Based Behavioral Treatment at week 24 and post drug-treatment at week 32
Indices of metabolic syndrome
Changes of insulin resistance assessed by fasting insulin used for homeostasis model assessment of insulin resistance (HOMA-IR) using the formula insulin [mU/l] x glucose [mmol/l]) / 22.5
Measured: Change from Baseline to post-Family Based Behavioral Treatment at week 24
Meal induced chances in brain activation to visual food cues
Change of brain response to visual food cues measured by functional magnetic resonance imaging in a priori regions of interest
Measured: Change from Baseline to post-Family Based Behavioral Treatment at week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Jan 202112 Feb 2026

First posted20 Aug 2020
Study start28 Jan 2021
Primary completion21 Aug 2025
Study completion12 Feb 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Childhood ObesityStudies of the same condition, open and under way.
More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 63 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04520490
Sponsor's protocol ID: STUDY00001984
Acronym: BASIC2
Status last verified: Dec 2025
First submitted: 31 Jul 2020
Last updated: 5 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Childhood Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children
ClinicalTrials.gov ID: NCT04520490
Acronym / sponsor ID: BASIC2 / STUDY00001984
Conditions: Childhood Obesity
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 63 participants (actual)
Lead sponsor: Seattle Children's HospitalUniversity, hospital or other
Collaborators: University of Washington
Study start: 28 Jan 2021 (actual)
Primary completion: 21 Aug 2025 (actual)
Study completion: 12 Feb 2026 (estimated)
First posted: 20 Aug 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Exenatide once weekly extended-release	Active comparator	Behavioral: Family Based Behavioral Treatment, Drug: Exenatide 2 mg [Bydureon]Weekly subcutaneous injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (2mg) for 24 weeks in randomized intervention.
Matching placebo	Placebo comparator	Behavioral: Family Based Behavioral Treatment, Drug: PlaceboWeekly subcutaneous injections of placebo for 24 weeks.

Who may qualify

Ages: 10 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (14 listed)

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;

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
Family Based Behavioral TreatmentChildren with obesity accompanied by at least one parent or caregiver will attend 24 weekly sessions. Most sessions will be held via video-conference and include 25-30 min. meetings between an interventionist and each child/parent pair to individualize treatment, followed by separate child and parent group meetings lasting 40 - 45 min. A select few sessions will be held in-person between an interventionist and each child/parent pair with no group session. Parents will serve as primary agents of change for their child and for themselves. Training will focus on food and physical activity education, parenting around food and physical activity, and use of behavioral skills (e.g., self-monitoring, environmental control, contingency management). Intervention groups of 8-12 children/families will be initiated every 3-6 mos. in study yrs. 2-3.	Behavioural	Exenatide once weekly extended-release, Matching placebo
Exenatide 2 mg [Bydureon]Also: Bydureon®Weekly injections of active drug.	Drug	Exenatide once weekly extended-release
PlaceboWeekly placebo injections	Drug	Matching placebo

Primary outcome

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
Body mass index (BMI) z-scores will be derived using CDC growth charts, using the LMS method, to allow for comparison of adiposity over time and across children who differ in age and sex.

4 secondary outcomes

BMI z-score
Time frame: Up to 12-months after ending treatment
Body composition
Time frame: Change from Baseline to post-Family Based Behavioral Treatment at week 24 and post drug-treatment at week 32
Indices of metabolic syndrome
Time frame: Change from Baseline to post-Family Based Behavioral Treatment at week 24
Meal induced chances in brain activation to visual food cues
Time frame: Change from Baseline to post-Family Based Behavioral Treatment at week 24

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 5 Jan 2026.
Individual participant dataSharing planned: No

Related trials for Childhood Obesity

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National Childhood Obesity Prevention Programme BE FIT 24
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RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
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RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
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Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
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Not yet recruiting
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Family Based Behavioral Treatment and Exenatide 2 mg [Bydureon] in people with Childhood Obesity, run by Seattle Children's Hospital 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 6 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 5 Jan 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04520490.

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 5 Jan 2026.