Clinical Trial

Bone Metabolism in 12-21 Year Olds Undergoing Glucagon Like Peptide (GLP)-1 Receptor Agonist Therapy

Recruiting Phase 2
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Summary
The goal of this clinical trial is to compare bone health markers over 24 months in participants 12 - 21 years of age with obesity who are starting the glucagon-like peptide-1 receptor agonists (GLP-1RAs) as compared to those with similar weight followed by lifestyle management. Participants will: * Take GLP-1RA as prescribed or continue to work on lifestyle management for weight loss * Take provided calcium and vitamin D supplements * Attend 6 study visits over 24 months with two at the beginning and then every 6 months that include: * History and Physical Exams * Lab Work * Imaging studies * Questionnaires * 24-hour dietary recalls
Protocol Amendment History 4 changes
critical Primary endpoint(s) modified 2026-04-18
critical Phase changed: not specified -> Phase 2 2026-04-08
notable Primary completion moved earlier: 2030-06-01 -> 2030-02-28 2026-04-01
minor Completion moved earlier: 2031-06-01 -> 2030-04-30 2026-04-01
Trial Details
NCT Number NCT06903923
Lead Sponsor University of Virginia
Collaborators: National Institutes of Health (NIH)
Conditions Obesity in Children, Bone Strength, GLP - 1, Lifestyle Modification, Bone Density, Obesity
Enrollment 120 participants
Start Date 2025-07-31
Primary Completion 2030-02-28 (estimated)
Study Completion 2030-04-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-17