NCT04520490Active, not recruitingPhase 3
Brain Activation and Satiety in Children 2
Brain Systems and Behaviors Underlying Response to Obesity Treatment in Children
Source: ClinicalTrials.gov · Last updated 5 Jan 2026
Brief summary (registry, in English)
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 once weekly extended-release (ExQW, Bydureon®) in order to improve obesity intervention outcomes in 10-12-year-old children.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 63 (actual)
- First submitted
- 31 Jul 2020
- Start date
- 28 Jan 2021
- Primary completion date
- 21 Aug 2025
- Lead sponsor
- Seattle Children's Hospital
- Diseases
- Obesity
- NCT number
- NCT04520490
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 63
- From 28 Jan 2021 to the primary completion date, 21 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of any implanted metal or metal devices, including ferro-metallic surgical clips or orthodontic braces;
- Current use of medications known to alter appetite, body weight, or brain response
- Use of weight loss medications (child participant) within 3 months of screening visit.
Other illness
- History of acute or chronic serious medical conditions;
- known diabetes mellitus or recent (6 mo.) history of anemia;
- Documented cognitive disorder, disruptive behavior, inability to participate in group sessions;
- Food intolerance to test meal (macaroni and cheese) or vegetarianism/veganism or severe food allergies.
- History of gastroparesis, pancreatitis or gallstones (unless status post cholecystectomy);
- Family history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma;
- Untreated thyroid disorder or adrenal insufficiency;
Lab values
- Known renal impairment (GFR\<60 ml/min/1.73m2)
Other
- Claustrophobia;
- Known elevated calcitonin level at phone screening or increased measured calcitonin level at study visits;
- Participating parent is pregnant
Who the study is looking for
- 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.
Age in the registry: 10 years to 12 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.