NCT06967389: MODERN

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

Recruiting now Last updated 1 July 2025

What this trial tests

trial testing Ozempic® in Obesity and Overweight in 50 participants. Currently enrolling.

Timeline

12 June 2025

Primary endpoint
1 July 2026

1 July 2027

Quick facts

Lead sponsor	John Bauer
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	50
Start date	12 June 2025
Primary completion	1 July 2026
Estimated completion	1 July 2027
Sites	1 location across United States

Drugs / interventions tested

• Ozempic® — full drug profile →

Conditions studied

• Obesity and Overweight — all drugs for Obesity and Overweight →
• Obese Adolescents — all drugs for Obese Adolescents →
• Weight Management — all drugs for Weight Management →
• Weight Loss — all drugs for Weight Loss →

Sponsor

John Bauer

Who can join

Adults 12 to 17, any sex, with Obesity and Overweight or Obese Adolescents. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in medication use
  Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
  This will be assessed by reviewing changes in the electronic medical record
• Change in Lipid Profile
  Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
  plasma/serum samples will be analyzed. blood lipid panel to include total cholesterol (mg/dL), HDL (mg/dL), triglycerides (mg/dL), and LDL (mg/dL) will be assessed
• Change in C-reactive protein
  Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
  data obtained from blood samples
• Change in Tumor necrosis factor
  Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
  data obtained from blood samples
• Change in Interleukin-6
  Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
  data obtained from blood samples
• Change in Adiponectin
  Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
  data obtained from blood samples

Sponsor's own 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. 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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.