What this trial means for you
This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Exenatide 2 mg [Bydureon], Placebo for childhood obesity.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
Washington
- Seattle Children's Hospital — Seattle
View the official record on ClinicalTrials.gov →
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