Brain Activation and Satiety in Children 2

NCT04520490 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: STUDY00001984
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Obesity

Outcome Measures

Primary Outcomes (1)

• Change of BMI z-score

  Body mass index (BMI) z-scores will be derived using CDC growth charts, using the LMS method, to allow for comparison of adiposity over time and across children who differ in age and sex.

  Change from drug treatment randomization at week 8 of family-based behavioral treatment (FBT) to end of combined intervention (FBT + drug) at week 24 of FBT

Secondary Outcomes (4)

• BMI z-score

  Up to 12-months after ending treatment

• Body composition

  Change from Baseline to post-Family Based Behavioral Treatment at week 24 and post drug-treatment at week 32

• Indices of metabolic syndrome

  Change from Baseline to post-Family Based Behavioral Treatment at week 24

• Meal induced chances in brain activation to visual food cues

  Change from Baseline to post-Family Based Behavioral Treatment at week 24

Study Arms (2)

Exenatide once weekly extended-release

ACTIVE COMPARATOR

Weekly subcutaneous injections of glucagon-like peptide (GLP)-1 agonist exenatide once weekly extended-release (2mg) for 24 weeks in randomized intervention.

Behavioral: Family Based Behavioral Treatment; Drug: Exenatide 2 mg [Bydureon]

Matching placebo

PLACEBO COMPARATOR

Weekly subcutaneous injections of placebo for 24 weeks.

Behavioral: Family Based Behavioral Treatment; Drug: Placebo

Interventions

Family Based Behavioral Treatment BEHAVIORAL

Children with obesity accompanied by at least one parent or caregiver will attend 24 weekly sessions. Most sessions will be held via video-conference and include 25-30 min. meetings between an interventionist and each child/parent pair to individualize treatment, followed by separate child and parent group meetings lasting 40 - 45 min. A select few sessions will be held in-person between an interventionist and each child/parent pair with no group session. Parents will serve as primary agents of change for their child and for themselves. Training will focus on food and physical activity education, parenting around food and physical activity, and use of behavioral skills (e.g., self-monitoring, environmental control, contingency management). Intervention groups of 8-12 children/families will be initiated every 3-6 mos. in study yrs. 2-3.

Exenatide once weekly extended-release; Matching placebo

Exenatide 2 mg [Bydureon] DRUG

Weekly injections of active drug.

Also known as: Bydureon®

Exenatide once weekly extended-release

Placebo DRUG

Weekly placebo injections

Matching placebo

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 20, 2020
• Study Start: January 28, 2021
• Primary Completion: August 21, 2025
• Study Completion: February 12, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)