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GLP-1 Receptor Agonist

Behavioral Treatment + Exenatide for Childhood Obesity (BASIC2 Trial)

Phase 3
Recruiting
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Child has BMI z-score >95th percentile. for age and sex;
10-12 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12-months after ending treatment
Awards & highlights

BASIC2 Trial Summary

This trial will test a new combination of family-based behavioral treatment with a drug intervention using a GLP-1RA in order to improve obesity intervention outcomes in children aged 10-12.

Who is the study for?
This trial is for overweight or obese children aged 10-12, with at least one parent willing to engage in treatment. The child must be able to undergo fMRI scans, blood draws, and weekly injections. They should not have diabetes, cognitive disorders that affect group participation, or be on appetite-altering medications.Check my eligibility
What is being tested?
The study tests a family-based behavioral treatment combined with the drug Exenatide (Bydureon) for childhood obesity. It aims to see if this approach helps improve health outcomes better than usual treatments.See study design
What are the potential side effects?
Exenatide may cause digestive issues like nausea or vomiting, rare thyroid tumors, low blood sugar levels when taken with other diabetes medicines, kidney problems including kidney failure; severe stomach problems.

BASIC2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child's BMI is much higher than average for their age and sex.
Select...
I am between 10 and 12 years old.
Select...
I am willing and able to attend study visits, get fMRI scans, have blood drawn, and receive weekly injections.

BASIC2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12-months after ending treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12-months after ending treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of BMI z-score
Secondary outcome measures
BMI z-score
Body composition
Indices of metabolic syndrome
+1 more

BASIC2 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Exenatide once weekly extended-releaseActive Control2 Interventions
Weekly subcutaneous injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (2mg) for 24 weeks in randomized intervention.
Group II: Matching placeboPlacebo Group2 Interventions
Weekly subcutaneous injections of placebo for 24 weeks.

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
302 Previous Clinical Trials
5,216,660 Total Patients Enrolled
University of WashingtonOTHER
1,741 Previous Clinical Trials
1,847,702 Total Patients Enrolled

Media Library

Exenatide (GLP-1 Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT04520490 — Phase 3
Childhood Obesity Clinical Trial 2023: Exenatide Highlights & Side Effects. Trial Name: NCT04520490 — Phase 3
Exenatide (GLP-1 Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04520490 — Phase 3
Childhood Obesity Research Study Groups: Matching placebo, Exenatide once weekly extended-release

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research require participants to be above a certain age?

"To be eligible for this particular clinical trial, applicants must be aged between 10 to 12 years old. Out of the 634 clinical trials for seniors, and 252 trials for minors, this is the only one that falls in the 10 to 12 age bracket."

Answered by AI

Are there any open positions in this clinical trial for new patients?

"The most recent information available indicates that this clinical trial is still recruiting patients. The trial was first posted on 2021-01-28, and the last update was on 2022-10-24."

Answered by AI

Has this type of trial been done before?

"Currently, there are 21 ongoing Exenatide clinical trials in 11 cities and 9 countries. The first trial began in 2007 and, after completing Phase 3 drug approval, involved 21 patients. Since then, 18408 studies have been completed."

Answered by AI

Are there any harmful effects associated with Exenatide once weekly extended-release?

"Exenatide once weekly extended-release received a safety score of 3 from our Power team. This is because it is a Phase 3 trial, so while there is some evidence of efficacy, there is also multiple rounds of data supporting safety."

Answered by AI

Who meets the eligibility requirements for this trial?

"This particular clinical study is testing an intervention on 64 obese children aged 10-12. The child must have a BMI z-score in the 95th percentile for their age and sex. The trial is open to both boys and girls."

Answered by AI

How many people are participating in this clinical trial?

"That is correct, the clinical trial is recruiting. According to the information available on clinicaltrials.gov, the trial was posted on 2021-01-28 and was last edited on 2022-10-24. The trial is looking for 64 patients at 1 location."

Answered by AI

Who else is applying?

What site did they apply to?
Seattle Children's Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Brain Activation and Satiety in Children 2
Christian L Roth, MD 2021. "Brain Activation and Satiety in Children 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04520490.
All > Bydureon
~11 spots leftby Dec 2024
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