Recruiting

Semaglutide

Sponsor:

John Bauer

Code:

NCT06967389

Conditions

Obesity and Overweight

Obese Adolescents

Weight Management

Weight Loss

Cardiovascular Disease Risk Factor

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Ozempic®

Study Details

Brief 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). 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

Conditions

Obesity and Overweight

Obese Adolescents

Weight Management

Weight Loss

Cardiovascular Disease Risk Factor

Study ID

NCT06967389

Start date

Jun 12, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not 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)

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Arms

Treatment Group

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

Interventions

Ozempic®

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

Primary outcome measure

  • Change in medication use [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Lipid Profile [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in C-reactive protein [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Tumor necrosis factor [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Interleukin-6 [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Adiponectin [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Soluble Intercellular Adhesion Marker [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Systolic Blood pressure [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Diastolic Blood pressure [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in ambulatory blood pressure [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Cardiac structure [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Cardiac function (Ejection Fraction) [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Cardiac function (Stroke Volume (SV) [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Cardiac function (Cardiac Output (CO) [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Cardiac function (Wall motion) [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]
  • Change in Cardiac function (Valve motion) [ Time Frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment ]

Central Contacts and Locations

Central contacts

Margaret Murphy, RD PhD

859-323-2969maggie.murphy@uky.edu

Heather Collins, BSN RN CCRP

859-562-1103heather.collins1@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

Contacts

Amanda Wilburn, BA CCRP

8595620670amanda.wilburn@uky.edu

Nermin Ahmed, RD PhD

nermin.s@uky.edu

Principal Investigator:

John Bauer, PhD

More Information

Sponsor

John Bauer

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • semaglutide
  • Wegovy
  • Ozempic
  • obesity
  • overweight
  • adolescent
  • weight management
  • weight loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by John Bauer on 2026-07-21.