Obesity and OverweightMODERNNCT06967389
Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity
An observational study of Obesity and Overweight and Obese Adolescents, run by John Bauer at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obesity and Overweight, Obese Adolescents, Weight Management
- What is being tested?
- Ozempic®
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2025to Jul 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be recruited from the University of Kentucky's High BMI and/or Pediatric Nephrology Clinics.
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Amanda Wilburn, BA CCRP, 8595620670, amanda.wilburn@uky.edu
Nermin Ahmed, RD PhD, nermin.s@uky.edu
About this study
Official title: Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)
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?
Read more
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
Read the 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
- Being tested
- Ozempic®
- Keywords
- semaglutide, Wegovy, Ozempic, obesity, overweight, adolescent, weight management, weight loss
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozempic®Drug
The study medication will be given in accordance with standard of care dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | All participants in this study will be given the study drug. Receives: Drug: Ozempic® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medication use
This will be assessed by reviewing changes in the electronic medical record
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Lipid Profile
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
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in C-reactive protein
data obtained from blood samples
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Tumor necrosis factor
data obtained from blood samples
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Interleukin-6
data obtained from blood samples
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Adiponectin
data obtained from blood samples
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Soluble Intercellular Adhesion Marker
data obtained from blood samples
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling
Changes in RAAS biomarkers at the defined study points will be evaluated.
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Systolic Blood pressure
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Diastolic Blood pressure
Blood pressure (systolic/diastolic) (mmHg) ambulatory blood pressure monitoring (ABPM) (mmHg) will be taken at the listed timepoints.
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in ambulatory blood pressure
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Cardiac structure
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed including overall heart and chamber size, wall thickness, etc.
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Cardiac function (Ejection Fraction)
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Cardiac function (Stroke Volume (SV)
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Cardiac function (Cardiac Output (CO)
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Cardiac function (Wall motion)
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Cardiac function (Valve motion)
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Secondary outcomes (16)
Change in Dietary habits
It assesses the frequency and quality of dietary habits, such as the consumption of fruits, vegetables, whole grains, and unhealthy foods like sugary snacks and fast food.
The scoring is typically based on a scale representing frequency:
0 = Never or less than once per week, 1 = 1-2 times per week, 2 = 3-4 times per week, 3 = 5-6 times per week, 4 = Daily or more.
Higher scores on the healthy scale = better dietary habits
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in exercise habits
Assessed with the BMI Clinic dietary and exercise habit survey in which participants record the frequency of activities.
It assesses the frequency, duration, and/or intensity of physical activity (e.g., walking, moderate activity, vigorous activity, including aerobic and strength training).
For interpretation:
High Score: Indicates sufficient physical activity Low Score: Suggests insufficient physical activity
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Patient Health Questionnaire-9 (PHQ-9)
The PHQ-9 is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively. Higher scores indicating greater depression severity.
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Generalized Anxiety Disorder-7 questionnaire (GAD-7)
A 7 item self-complete questionnaire with very good sensitivity (89%) and specificity (82%) for Generalised Anxiety Disorder (GAD). Response scores for each item ranging from 0 (not at all) to 3 (every day). The range for the total score is 0 to 21, with higher scores representing greater symptoms of anxiety
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Anthropomorphic outcomes - Body Mass Index (BMI)
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Anthropomorphic outcomes - Waist circumference
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Anthropomorphic outcomes - Bioimpedence
Whole-body electrical resistance will be measured with the subjects using the BodyStat Quadscan 4000 Bioelectric Impedance Analyzer
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Anthropomorphic outcomes - Resting metabolic rate
A handheld resting metabolic rate (RMR) calculator/indirect calorimeter (MedGem RMR) will be used to estimate the RMR (caloric needs).
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Anthropomorphic outcomes - Cardiorespiratory Fitness
Maximal Graded Exercise Testing (Maximal GXT): The maximal graded exercise tests will be performed using an indirect calorimetry testing system
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in complete blood count (CBC)
plasma/serum samples will be analyzed
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Liver panel profile
-plasma/serum samples will be analyzed. The individual components are grouped as a panel to for an overall evaluation of the system's functioning
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Renal panel profile
-plasma/serum samples will be analyzed. The individual components are grouped as a panel to for an overall evaluation of the system's functioning
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Thyroid panel profile
-plasma/serum samples will be analyzed. The individual components are grouped as a panel to for an overall evaluation of the system's functioning
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Fasting glucose
-plasma/serum samples will be analyzed
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Fasting Insulin
-plasma/serum samples will be analyzed
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, (HOMA-IR)
Measured: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start12 Jun 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Bauer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John Bauer, University of Kentucky
- Investigators
- John Bauer, PhD, Study chair, University of KentuckyMargaret Murphy, RD PhD, Principal investigator, University of KentuckyAurelia Radulescu, MD, Study director, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967389
- Sponsor's protocol ID
- 98420
- Acronym
- MODERN
- Status last verified
- Jul 2026
- First submitted
- 25 Feb 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes