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Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

NCT06967389 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-07-04

No results posted yet for this study

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

Conditions

Interventions

DRUG

Ozempic®

The study medication will be given in accordance with standard of care dosing schedule.

Sponsors & Collaborators

  • John Bauer

    lead OTHER

Principal Investigators

  • John Bauer, PhD · University of Kentucky

  • Margaret Murphy, RD PhD · University of Kentucky

  • Aurelia Radulescu, MD · University of Kentucky

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2026-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06967389 on ClinicalTrials.gov