NCT06967389 · John Bauer
Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity
(MODERN)
What this study is about
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).
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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)
Where
- Lexington, Kentucky
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 4, 2025 · Source of record for eligibility and locations