Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Launched by JOHN BAUER · May 2, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called semaglutide on children aged 12 to 15 who are classified as extremely obese. The main goal is to see how this medication can help reduce weight and improve health markers related to heart disease in these young people. Researchers will look at things like weight loss, body measurements, heart health, and how well participants can exercise. They are also interested in whether there are differences in these effects between boys and girls.

To participate, children must be seen at the University of Kentucky Pediatric High BMI Clinic and diagnosed with obesity (Class 2 or 3). They cannot be currently taking certain weight loss or blood pressure medications, or have specific health issues that could affect their participation. Those who join will receive semaglutide and will undergo tests like heart scans and fitness assessments before and after one year of treatment. They'll also have regular check-ups with the study doctor, and if a participant is female and has started their period, they will need to take a pregnancy test. This trial is not yet recruiting participants, but it aims to provide important information about managing obesity in children.

Gender

ALL

Eligibility criteria

• 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)