NCT06967389

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: John Bauer · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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

Detailed description

This is an observational study in which all participants will be given semaglutide. There will be no randomization and no placebo. Participants will be in the study for 12 months (+/- 2 months) depending on when they reach the maintenance dose of semaglutide. Blood and urine will be maintained by the principal investigator indefinitely. Identifiers will be removed from the samples. Approximately 50 patients will be enrolled. The study drug, Ozempic, is FDA approved.

Conditions

• Obesity and Overweight
• Obese Adolescents
• Weight Management
• Weight Loss
• Cardiovascular Disease Risk Factor

Interventions

Type	Name	Description
DRUG	Ozempic®	The study medication will be given in accordance with standard of care dosing schedule.

Timeline

• Start date: 2025-06-12
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2025-05-13
• Last updated: 2025-07-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study