Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-12

Study Completion Date

2027-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Semaglutide Effects on Cardiovascular Outcomes in People With Overweight or Obesity in the Real World

NCT06874751

Overweight Obesity Atherosclerotic Cardiovascular Disease (ASCVD)

COMPLETED

A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity

NCT04102189

Overweight Obesity

COMPLETED PHASE3

Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice

NCT07302802

Monogenic Obesity

RECRUITING

A Research Study of How NNC0174-0833 Taken With Semaglutide Works in People Who Are Overweight or Obese

NCT03600480

Obesity Overweight

COMPLETED PHASE1

A Study of Tirzepatide (LY3298176) in Pediatric Participants With Obesity

NCT05696847

Obesity

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment Group

All participants in this study will be given the study drug.

Ozempic®

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ozempic®

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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 Criteria

* 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)

Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No