Behavioral Treatment + Exenatide for Childhood Obesity

(BASIC2 Trial)

Overseen By Clinton T Elfers

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Seattle Children's Hospital

Must be taking: Glucagon-like peptide-1

Must not be taking: Appetite-altering medications

Disqualifiers: Diabetes, Cognitive disorder, Renal impairment, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

63 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that participants do not use medications known to alter appetite, body weight, or brain response. If you are taking such medications, you may need to stop them to participate.

What evidence supports the effectiveness of the drug exenatide for treating childhood obesity?

Research shows that exenatide can significantly reduce BMI and body weight in children and adolescents with extreme obesity, along with improving insulin sensitivity and β-cell function, suggesting it may be effective for managing childhood obesity. ^{1 2 3 4 5}

Is the combination of behavioral treatment and Exenatide safe for children with obesity?

Exenatide has been used in adolescents with obesity and in adults with type 2 diabetes, but there have been reports of gastrointestinal issues and a case of acute pancreatitis (inflammation of the pancreas) in adults. It's important to monitor for side effects and consult with healthcare providers. ^{1 3 6 7 8}

How is the drug Exenatide unique in treating childhood obesity?

Exenatide is unique for childhood obesity as it is a GLP-1 receptor agonist (a type of drug that mimics a hormone to help control blood sugar and appetite) that can be administered once weekly, which is more convenient than daily treatments. It has shown promise in reducing BMI and improving insulin sensitivity in children with extreme obesity, making it a novel option compared to traditional lifestyle modifications alone. ^{1 2 5 8 9}

Eligibility Criteria

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.

Inclusion Criteria

Parent willing to provide informed written consent and child willing to provide written assent;

One of my parents is overweight and one is willing to join a weight control program.

My child's BMI is much higher than average for their age and sex.

Exclusion Criteria

I have had gastroparesis, pancreatitis, or gallstones, but I've had my gallbladder removed if I had gallstones.

You cannot eat the test meal (macaroni and cheese) due to food intolerance, or you are a vegetarian/vegan or have severe food allergies.

You have metal implants in your body, including surgical clips or braces.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive family-based behavioral treatment (FBT) combined with weekly subcutaneous injections of either placebo or GLP-1RA exenatide for 24 weeks

24 weeks

Weekly visits for injections

Follow-up

Participants are monitored for safety and effectiveness after treatment, including changes in BMI z-score and body composition

12 months

Treatment Details

Interventions

• Exenatide
• Family Based Behavioral Treatment
• Placebo

Trial Overview 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.

Participant Groups

Group I: Exenatide once weekly extended-release Active Control 2 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 placebo Placebo Group 2 Interventions

Weekly subcutaneous injections of placebo for 24 weeks.

Exenatide is already approved in United States, European Union for the following indications:

Approved in United States as Byetta for:

• Type 2 diabetes mellitus

Approved in United States as Bydureon for:

• Type 2 diabetes mellitus

Approved in United States as Bydureon BCise for:

• Type 2 diabetes mellitus

Approved in European Union as Byetta for:

• Type 2 diabetes mellitus

Approved in European Union as Bydureon for:

• Type 2 diabetes mellitus

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Findings from Research

Bydureon, a long-acting formulation of exenatide, allows for once-weekly injections, significantly reducing glycated hemoglobin (HbA1c) levels while maintaining similar weight loss and better digestive tolerance compared to the original twice-daily formulation.

In clinical comparisons, Bydureon has shown greater efficacy than other glucose-lowering medications like sitagliptin and pioglitazone, without causing hypoglycemia, making it a safer option for managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Bydureon: first once weekly GLP-1 receptor agonist (exenatide LAR)]. Scheen, AJ.[2022]

In a study of 150 patients with type 2 diabetes, adding once-weekly exenatide to basal insulin therapy resulted in a significant reduction in HbA1c levels by 0.7% after one year, comparable to the 0.8% reduction seen with once-daily liraglutide.

Patients on exenatide were more likely to achieve an HbA1c of less than 7% compared to those on liraglutide, with no increase in hypoglycemia incidents, indicating that exenatide is a safe and effective addition to insulin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A real-world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672). Stryker, MD., Kane, MP., Busch, RS.[2023]

Exenatide (Byetta) was prescribed to a female type 2 diabetic patient for glycemic control, but she experienced gastrointestinal disturbances from the first day of treatment.

After eight days of using Exenatide, the patient developed acute pancreatitis, which was confirmed by CT scan; the medication was discontinued, and her symptoms improved with treatment for pancreatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exenatide and acute pancreatitis. Tripathy, NR., Basha, S., Jain, R., et al.[2018]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Adolescents with obesity treated with exenatide maintain endogenous GLP-1, reduce DPP-4, and improve glycemic control. [2023]

2. Belgium pubmed.ncbi.nlm.nih.gov

[Bydureon: first once weekly GLP-1 receptor agonist (exenatide LAR)]. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A real-world, observational study of weekly exenatide added to basal insulin in patients with type 2 diabetes mellitus (NCT02895672). [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Once-weekly exenatide as adjunct treatment of type 1 diabetes mellitus in patients receiving continuous subcutaneous insulin infusion therapy. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Exenatide as a weight-loss therapy in extreme pediatric obesity: a randomized, controlled pilot study. [2022]

6. India pubmed.ncbi.nlm.nih.gov

Exenatide and acute pancreatitis. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of exenatide in combination with insulin in patients with type 2 diabetes mellitus. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Exenatide for weight-loss maintenance in adolescents with severe obesity: A randomized, placebo-controlled trial. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

Recent results of exenatide use as adjunctive therapy in the treatment of patients with type 2 diabetes. [2021]