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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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Seattle Children's Hospital
Coordinator of this site? Confirm its status
SeattleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.