An observational study in Obesity and Overweight, Obese Adolescents and Weight Management, sponsored by John Bauer. Recruiting at 1 site in United States. Open to participants aged 12 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by John Bauer · Observational
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:
Participants will be given semaglutide for this study. During the course of the study, participants will:
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 50 is below the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with John Bauer as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Participants will be recruited from the University of Kentucky's High BMI and/or Pediatric Nephrology Clinics.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants in this study will be given the study drug.
Drug: Ozempic®
The study medication will be given in accordance with standard of care dosing schedule.
Change in medication use
This will be assessed by reviewing changes in the electronic medical record
Time frame: 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
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in C-reactive protein
data obtained from blood samples
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Tumor necrosis factor
data obtained from blood samples
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Interleukin-6
data obtained from blood samples
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Adiponectin
data obtained from blood samples
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Soluble Intercellular Adhesion Marker
data obtained from blood samples
Time frame: 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.
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
Blood pressure (systolic/diastolic) (mmHg) ambulatory blood pressure monitoring (ABPM) (mmHg) will be taken at the listed timepoints.
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
Changes from baseline cardiac MRI and/or cardiac echocardiograms (ECHO) will be assessed including overall heart and chamber size, wall thickness, etc.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Anthropomorphic outcomes - Body Mass Index (BMI)
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Anthropomorphic outcomes - Waist circumference
Time frame: 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
Time frame: 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).
Time frame: 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
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in complete blood count (CBC)
plasma/serum samples will be analyzed
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Fasting glucose
-plasma/serum samples will be analyzed
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in Fasting Insulin
-plasma/serum samples will be analyzed
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Change in hyperglycemia assessed by Homeostatic Model Assessment of Insulin Resistance, (HOMA-IR)
Time frame: Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment
Plan to share: Yes
No publications or documents are linked to this record.
Started Jun 2025 (actual). Primary completion is estimated for Jul 2027, 25 months after the start.
Of 791 non-industry observational studies under Obesity, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 106. This study's planned 25 months is below that.
Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.