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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