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Observational Study of Ozempic for Cardiovascular Risk in Children with Extreme Obesity

This observational study is looking at how Ozempic (semaglutide) affects children aged 12-17 with severe obesity (Class 2 or 3). The goal is to understand if Ozempic can help reduce risks for heart disease. Researchers will observe changes in medication use, cholesterol levels (lipid profile), and inflammation markers (C-reactive protein) over 12 months. You might be able to join if you are a patient at the University of Kentucky Pediatric High BMI Clinic, have Class 2 or 3 obesity, and meet the criteria for semaglutide treatment. The study is currently unclear on its recruitment status and plans to enroll about 50 participants.

Study design
This is an observational study where all 50 participants will receive Ozempic (semaglutide). There is no randomization or placebo group.
What's involved
You will be in the study for about 12 months. Blood and urine samples will be collected at enrollment, 6 months, and 12 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months (+/- 2 months) after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible ā€” confirm details with them before making decisions.

NCT06967389

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Recruiting
Not specifiedAges 12ā€“17Observational
John Bauer
~50 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:OzempicĀ®

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in medication use
Measured over Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
+16 more outcomes measured

Conditions

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

Explore related trials

Obesity

Where it's being run

1 sites across 1 states
Kentucky1

Study leadership

  • John Bauer, PhD Ā· STUDY_CHAIR Ā· University of Kentucky
  • Margaret Murphy, RD PhD Ā· PRINCIPAL_INVESTIGATOR Ā· University of Kentucky
  • Aurelia Radulescu, MD Ā· STUDY_DIRECTOR Ā· University of Kentucky

Who to contact

Margaret Murphy, RD PhD
[email protected]
859-323-2969
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Exclusion

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.
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)

What this trial measures

  • Change in medication useEnrollment, 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 ProfileEnrollment, 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 proteinEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    data obtained from blood samples

  • Change in Tumor necrosis factorEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    data obtained from blood samples

  • Change in Interleukin-6Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    data obtained from blood samples

  • Change in AdiponectinEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    data obtained from blood samples

  • Change in Soluble Intercellular Adhesion MarkerEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    data obtained from blood samples

  • Changes in Renin-Angiontensin-Alsosterone System biomarkers profilingEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    Changes in RAAS biomarkers at the defined study points will be evaluated.

  • Change in Systolic Blood pressureEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
  • Change in Diastolic Blood pressureEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    Blood pressure (systolic/diastolic) (mmHg) ambulatory blood pressure monitoring (ABPM) (mmHg) will be taken at the listed timepoints.

  • Change in ambulatory blood pressureEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
  • Change in Cardiac structureEnrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed including overall heart and chamber size, wall thickness, etc.

  • Change in Cardiac function (Ejection Fraction)Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  • Change in Cardiac function (Stroke Volume (SV)Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  • Change in Cardiac function (Cardiac Output (CO)Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  • Change in Cardiac function (Wall motion)Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.

  • Change in Cardiac function (Valve motion)Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

    Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed.