A study testing whether a study medicine from University of Virginia, GLP-1 receptor agonist, can help with weight.
- Who can join
- Ages 12 to 21, have obesity.
- What you take
- GLP-1 receptor agonist, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
- How long it lasts
- The full study runs about 4.8 years; your own time in it is usually shorter.
- What you get
- The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
What this study is for
Primary condition: Obesity in Children. Also studied in: Bone Strength, GLP - 1, Lifestyle Modification, Bone Density, Obesity.
Full scientific study title: Bone Metabolism in 12-21 Year Olds Undergoing Glucagon Like Peptide (GLP)-1 Receptor Agonist Therapy.
Who can join
Ages 12 to 21, have obesity. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.
Full medical eligibility (for you and your doctor)verbatim from the registry
This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.
Key inclusion criteria
- • Adolescents and young adults with obesity 12-21 years old starting GLP-1 RA therapy (except for dulaglutide or exenatide) or followed with 'usual' care.
- Diagnosis of obesity (BMI >= 95th percentile for age and sex). The FDA has approved the use of GLP-1 RAs (liraglutide and semaglutide) for adolescents >= 12 years old with BMI >= 95th percentile for age and sex, and tirzepatide for adults with obesity. Those in the GLP-1 RA arm must have demonstrated efforts at weight loss with 'usual' care, and consistent compliance with appointments and recommendations.
- Participants must demonstrate sufficient maturity, psychological stability and cognitive capacity to recognize the significance of being on medical therapy and implement required behavioral changes
- Patients taking orlistat as a precursor to GLP-1 RA therapy due to insurance requirements may be included given minimal effects on weight.
- Use of the following contraceptive methods is permitted: Combine oral contraceptives (COCs); continuous oral progestin; Progestin-releasing intrauterine device (IUD); Progestin implant; transdermal patch.
Key exclusion criteria
- • Current or previous history of pregnancy and breast feeding.
- Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 if in the GLP-1 RA group.
- > 5 kg weight loss over 3 months given the known impact of significant weight loss on bone density.
- Use of dulaglutide and exenatide (of the GLP-1 RAs) given minimal weight loss with these drugs.
- Use of medications such as metformin, phentermine, or topiramate that may cause weight loss, or obesogenic antipsychotic medications if treated for <3 months, or if dosage is not stable for >2 months.
Where this study is enrolling
This trial has 1 sites across 1 state. Contact a site coordinator directly to start screening.
Virginia1 site
- University of Virginia Medical CenterCharlottesville, Virginia
Timeline
Started enrolling: 2025-07-31. Expected completion: 2030-04-30. Last updated on ClinicalTrials.gov: 2026-04-17.
Official source
We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:
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