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Could a weekly shot help kids with obesity? new trial tests combo therapy

NCT ID NCT04520490

Disease control Sponsor: Seattle Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a weekly injection of exenatide (Bydureon) to family-based behavioral treatment helps children aged 10-12 with obesity lose weight more effectively. The trial involves 63 children and their parents, with weekly sessions over 24 weeks. Researchers will measure changes in body mass index (BMI) and body composition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
exenatide (Bydureon) once weekly injection
What this could lead to
If successful, this combination approach could offer a more effective way to help children with obesity achieve lasting weight control.
What could go wrong
This is a small, early-phase study (63 participants) and results may not apply to all children. The drug exenatide can cause side effects like nausea, and long-term safety in children is not yet established.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

63 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

10 to 12 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

obesity disorder Pediatric Obesity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Childhood obesity

Contacts and locations

Locations

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.