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New treatment option for Obesity in Children
Official title Bone Metabolism in 12-21 Year Olds Undergoing Glucagon Like Peptide (GLP)-1 Receptor Agonist Therapy
ClinicalTrials.gov ID: NCT06903923
What this study is testing
What is GLP-1 receptor agonist?
GLP-1 receptor agonist is an investigational medicine, being studied as a potential treatment for obesity in children.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 21
You may be able to join if
- Adolescents and young adults with obesity 12-21 years old starting GLP-1 RA therapy (except for dulaglutide or exenatide) or followed with 'usual'...
- 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...
- Participants must demonstrate sufficient maturity, psychological stability and cognitive capacity to recognize the significance of being on medical...
- 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...
You likely can't join if
- 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 \...
- Medications other than calcium or vitamin D that affect bone, such as systemic glucocorticoids, phenytoin, phenobarbitone (unless there is a washout...
See the full eligibility 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...
- 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.
- Patients with celiac disease will be included if the condition is well controlled and they are on a gluten free diet with normal 25(OH)D levels confirmed by clinical labs within 3 months of enrollment in the study. If a...
- 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 \ 2 months.
- Medications other than calcium or vitamin D that affect bone, such as systemic glucocorticoids, phenytoin, phenobarbitone (unless there is a washout period of 3 months prior to enrollment if discontinuation is medically...
- Female participants on hormonal contraception will be excluded if this involves use of depot medroxyprogesterone acetate (DMPA). DMPA has profound deleterious effect on bone density, which could confound study outcomes...
- Untreated thyroid dysfunction or on stable dose for \<3 months. Primary thyroid dysfunction will be defined as: a TSH ≥ 10 IU/L or low per given reference range with unknown thyroid antibody status, or an abnormal TSH...
- Medical conditions known to impact weight or bone density, such as chronic gastrointestinal disorders (including inflammatory bowel disease), other inflammatory conditions, such as rheumatoid arthritis or ankylosing...
- HbA1C \>8% (to avoid deleterious effects on bone from uncontrolled T2DM).
- Smoking \>10 cigarettes/day given deleterious effects on bone; substance abuse per DSM-5.
- Weight \>450 lbs due to limits for DXA scanners.
- History of metabolic and bariatric surgery.
- Judged by the investigators to be inappropriate for the study for other reasons not detailed above.
The study team makes the final eligibility decision.
Where it's taking place
- Charlottesville, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charlottesville, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.