NCT06967389Recruiting
Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity
Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 25 Feb 2025
- Start date
- 12 Jun 2025
- Primary completion date
- Jul 2027
- Lead sponsor
- John Bauer
- Diseases
- Obesity
- NCT number
- NCT06967389
What you commit to
- Study type: Observational
- Planned participants: 50
- From 12 Jun 2025 to the primary completion date, Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 systemic steroid use longer than 3 month use or within the last month before enrollment (not including inhaled, ophthalmic, intranasal, and topical).
Other illness
- Any specific end-organ acute concerns (kidney disease, liver disease, congenital disease).
- Any active infections at enrollment.
- Any congenital abnormality or genetic syndrome known to be associated with obesity
- Personal or family history of medullary thyroid carcinoma (per product insert)
- Patients with Multiple Endocrine Neoplasia syndrome type 2 (per product insert)
Other
- Any limitations that would make exercise testing not possible.
- Pregnancy
- Inability to receive an MRI
Who the study is looking for
- 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
Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Kentucky Coordinator of this site? Confirm its status | Lexington | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.