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MODERN

Recruiting

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity

Mitigation of Cardiovascular Disease Risks in Children With Extreme Obesity (MODERN)

Lead sponsor

John Bauer

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Obesity / overweight

Key I/E criterion

•Age 12-17

Primary endpoints

•Medication use•Lipid Profile•Hs-CRP, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06967389

Org study ID98420

Timeline

Milestones

Study first posted2025-05-13actual

Study start2025-06-12actual

Last update posted2025-07-04actual

Primary completion2026-07estimated (month precision)

Study completion2027-07estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years

Maximum age17 Years

SexAll

Healthy volunteersNot accepted

Sampling methodNon probability sample

Study population text

Participants will be recruited from the University of Kentucky's High BMI and/or Pediatric Nephrology Clinics.

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)

Endpoints (33)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Other clinical outcomes

Patient-reported / QoL

Safety / tolerability / PK

MASH / liver

Renal / kidney

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Change in Anthropomorphic outcomes - Body Mass Index (BMI)

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Anthropomorphic outcomes - Waist circumference

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Anthropomorphic outcomes - Bioimpedence

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, descriptive

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change in Fasting glucose

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Insulin

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Secondary/protocol endpoint

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

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Liver panel profile

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Renal panel profile

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Cardiometabolic biomarkers

7 endpoints

Primary/protocol endpoint

Change in Lipid Profile

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Primary/protocol endpoint

Change in C-reactive protein

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Primary/protocol endpoint

Change in Adiponectin

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Adiponectin, change

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Soluble Intercellular Adhesion Marker

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Primary/protocol endpoint

Change in Systolic Blood pressure

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Primary/protocol endpoint

Change in Diastolic Blood pressure

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Primary/protocol endpoint

Change in ambulatory blood pressure

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Patient Health Questionnaire-9 (PHQ-9)

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

descriptive, improvement

Secondary/protocol endpoint

Generalized Anxiety Disorder-7 questionnaire (GAD-7)

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

descriptive, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Change in complete blood count (CBC)

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, descriptive

Secondary/protocol endpoint

Change in Thyroid panel profile

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, descriptive

Other clinical outcomes

3 endpoints

Secondary/protocol endpoint

Change in Dietary habits

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Secondary/protocol endpoint

Change in exercise habits

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in Anthropomorphic outcomes - Cardiorespiratory Fitness

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Other (unclassified)

11 endpoints

Primary/protocol endpoint/low confidence

Change in medication use

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

descriptive

Primary/protocol endpoint/low confidence

Change in Tumor necrosis factor

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Interleukin-6

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Primary/protocol endpoint/low confidence

Changes in Renin-Angiontensin-Alsosterone System biomarkers profiling

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

descriptive

Primary/protocol endpoint/low confidence

Change in Cardiac structure

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Cardiac function (Ejection Fraction)

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Cardiac function (Stroke Volume (SV)

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Cardiac function (Cardiac Output (CO)

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Cardiac function (Wall motion)

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in Cardiac function (Valve motion)

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in Anthropomorphic outcomes - Resting metabolic rate

Time frame:Enrollment, 6 months post enrollment, 12 months +/- 2 months post enrollment

change from baseline, descriptive

Publications (10)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

AI-Driven De Novo Design of Ultra Long-Acting GLP-1 Receptor Agonists.
Advanced science (Weinheim, Baden-Wurttemberg, Germany)2025 Oct (month)PMID40787887doi:10.1002/advs.202507044via pubmed acronym asset candidate
A GLP-1 analogue optimized for cAMP-biased signaling improves weight loss in obese mice.
Molecular metabolism2025 Oct (month)PMID40157531doi:10.1016/j.molmet.2025.102124via pubmed acronym asset candidate
Obesity: Clinical Impact, Pathophysiology, Complications, and Modern Innovations in Therapeutic Strategies.
Medicines (Basel, Switzerland)2025 Jul 28PMID40843857doi:10.3390/medicines12030019via pubmed acronym asset candidate
Obesity-Related Glomerulosclerosis-How Adiposity Damages the Kidneys.
International journal of molecular sciences2025 Jun 28PMID40650024doi:10.3390/ijms26136247via pubmed acronym asset candidate
Preparation and Therapeutic Evaluation of Engineered Semaglutide and Statin-Lipid Conjugate-Based Nanoparticle.
Pharmaceutics2025 Apr 7PMID40284475doi:10.3390/pharmaceutics17040480via pubmed acronym asset candidate
Injections vs. Scalpels: Where Do Surgery and GLP-1's Align in Modern Obesity treatment?
Missouri medicine2025 Jul-Aug (year)PMID40787019via pubmed acronym asset candidate
Pharmacological Nephroprotection in Chronic Kidney Disease Patients with Type 2 Diabetes Mellitus-Clinical Practice Position Statement of the Polish Society of Nephrology.
International journal of molecular sciences2024 Dec 2PMID39684653doi:10.3390/ijms252312941via pubmed acronym asset candidate
Newer Insulin Preparations and Insulin Analogs.
Cureus2024 Nov (month)PMID39734941doi:10.7759/cureus.74593via pubmed acronym asset candidate
Syndromic and Monogenic Obesity: New Opportunities Due to Genetic-Based Pharmacological Treatment.
Children (Basel, Switzerland)2024 Jan 25PMID38397265doi:10.3390/children11020153via pubmed acronym asset candidate
Therapeutic advances in obesity management: an overview of the therapeutic interventions.
Frontiers in endocrinology2024 (year)PMID38715796doi:10.3389/fendo.2024.1364503via pubmed acronym asset candidate

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.