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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help children with obesity by combining a family-based behavioral treatment with the drug exenatide. Exenatide may help control hunger and weight. The study aims to determine if this combination is more effective in helping children manage their weight compared to using a single treatment. It is suitable for children aged 10-12 with a high BMI and a parent who is also overweight or obese, and who can attend study visits and participate in treatments. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment for childhood obesity.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that exenatide, a medication used in this study, has generally been well-tolerated in past studies with children and teenagers. Some research on exenatide for severe obesity in children has shown it might help with blood sugar control without major effects on insulin levels. However, while exenatide is approved for adults with type 2 diabetes, its safety and effectiveness for children under 10 remain uncertain.

The family-based behavioral treatment (FBT) in the study has successfully helped children lose weight and develop healthy eating and exercise habits. This method is considered safe and effective for managing childhood obesity, though not all children may respond the same way.

Overall, past studies suggest that both exenatide and FBT are generally well-tolerated, with no major side effects reported. Participants should discuss possible risks and benefits with the study team before joining. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for childhood obesity, which often focus on lifestyle changes and medications like metformin, exenatide offers a unique approach. Exenatide is a glucagon-like peptide-1 (GLP-1) agonist, which means it helps regulate blood sugar levels and appetite by mimicking a hormone that encourages insulin production and slows stomach emptying. This mechanism can lead to more significant weight loss compared to traditional treatments. Researchers are excited about using exenatide because it targets the underlying biological processes of obesity rather than just the symptoms, potentially offering a more effective solution for managing weight in children.

What evidence suggests that this trial's treatments could be effective for childhood obesity?

Research has shown that exenatide, a medication that helps control blood sugar and appetite, can aid children and teens in losing weight and lowering their BMI. In this trial, some participants will receive exenatide, which studies have demonstrated helps children lose more weight than those who do not receive it. It also improves key risk factors for type 2 diabetes. Another group in this trial will receive family-based behavioral treatment (FBT), which involves the whole family in making lifestyle changes and has effectively helped children achieve better weight outcomes. Together, these methods aim to enhance weight loss and overall health in children dealing with obesity. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11022205/

Exenatide for obesity in children and adolescents

Compared with controls, exenatide therapy reduced body weight and BMI by −0.6% (95% CI −0.93, −0.27), −1.11% (95% CI −1.91, −0.31), respectively ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3684414/

Exenatide as a Weight-Loss Therapy in Extreme Pediatric ...

In conclusion, we provide preliminary evidence that exenatide reduces BMI and body weight and improves important risk factors for T2DM in children and ...

3.

frontiersin.org

frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1293093/full

Adolescents with obesity treated with exenatide maintain ...

Adolescents with obesity treated with exenatide maintain endogenous GLP-1, reduce DPP-4, and improve glycemic control · Obesity rates amongst the ...

4.

astrazeneca-us.com

astrazeneca-us.com/media/press-releases/2021/bydureon-bcise-exenatide-extended-release-approved-in-the-us-for-the-treatment-of-type-2-diabetes.html

BYDUREON BCise (exenatide extended-release) ...

BYDUREON BCise (exenatide extended-release) is the first once-weekly GLP-1 RA treatment option for pediatric patients with type 2 diabetes in the US.

5.

mdpi.com

mdpi.com/1424-8247/17/7/828

Comparative Efficacy and Safety of Glucagon-like Peptide- ...

Exenatide also led to greater weight loss (DMD: −3.47 kg; 95% CI: −5.82, −1.24) versus placebo. Liraglutide, however, was not significantly ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01237197

NCT01237197 | Exenatide in Extreme Pediatric Obesity

Our primary objective in this study is to generate preliminary data on the ability of exenatide to reduce body mass index (BMI) and improve risk factors for ...