RecruitingNot Applicable

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

United States50 participantsStarted 2025-06-12

Plain-language summary

The goal of this clinical trial is to learn if the drug semaglutide changes markers of disease risk as it relates to weight in children ages 12-15 years old who are obese (class 2 or 3). The main questions it aims to answer are: * How do the rate of weight loss, body mass index (BMI), body composition, heart structure and function, and exercise ability interact with one another in the study population at enrollment? * How do risk markers of disease change over the study in the study participants who are given semaglutides to help with weight loss? * Are there differences in the above factors between males and females and are there key factors to help improve the outcomes? Participants will be given semaglutide for this study. During the course of the study, participants will: * have two cardiac MRI scans OR two cardiac echocardiograms (one before starting semaglutide and one around 12 months after taking the drug) * have body composition and fitness levels assessed twice (before semaglutide and around 12 months after taking it) and have urine specific gravity (USG) measured * have extra blood drawn when labs their doctor orders are already being drawn (once at the beginning of the study, once around 6 months after enrollment, and once at the end of the study) * have follow up visits with the study doctor * be asked to take a pregnancy test if they are female and have started menstruation

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient seen at University of Kentucky Pediatric High BMI Clinic * Diagnosis of Obesity Class 2 or 3 * Meeting the clinical criteria for the medical intervention with semaglutide for weight loss Exclusion Criteria: * Any current prescribed anti-obesity medications (AOM) such as Orlistat, Phentermine, Qsymia (Phentermine/Topiramate), Liraglutide, Semaglutide, and Setmelanotide * Any current prescribed anti-hypertensive medications * Any specific end-organ acute concerns (kidney disease, liver disease, congenital disease). * Any active infections at enrollment. * Any systemic steroid use longer than 3 month use or within the last month before enrollment (not including inhaled, ophthalmic, intranasal, and topical). * Any limitations that would make exercise testing not possible. * Any congenital abnormality or genetic syndrome known to be associated with obesity * Pregnancy * Inability to receive an MRI * Personal or family history of medullary thyroid carcinoma (per product insert) * Patients with Multiple Endocrine Neoplasia syndrome type 2 (per product insert)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in medication use

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Lipid Profile

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in C-reactive protein

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Tumor necrosis factor

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Interleukin-6

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Adiponectin

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Soluble Intercellular Adhesion Marker

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Trial details

NCT IDNCT06967389

SponsorJohn Bauer

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-07

Contact for this trial

Margaret Murphy, RD PhD

859-323-2969 maggie.murphy@uky.edu

View on ClinicalTrials.gov More Obesity and Overweight trials

Plain-language summary

Who can participate

Age range

12 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in medication use

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Lipid Profile

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in C-reactive protein

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Tumor necrosis factor

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Interleukin-6

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Adiponectin

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Change in Soluble Intercellular Adhesion Marker

Timeframe: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment