GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT06903923

RecruitingPhase 2

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

Bone Metabolism in Adolescents Undergoing GLP-1 Receptor Agonist Therapy

Lead sponsor

University of Virginia

Assets

GLP-1 / incretin class catch-all / Liraglutide / Semaglutide

Listed sites

Recruiting sites

Enrollment

120

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•24-month change in total vBMD at the distal radius

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 IDNCT06903923

Org study IDHSR302394

Secondary IDR01HD118635

Timeline

Milestones

Study first posted2025-04-01actual

Study start2025-07-31actual

Last update posted2026-04-17actual

Primary completion2030-02-28estimated

Study completion2030-04-30estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all Liraglutide Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age12 Years

Maximum age21 Years

SexAll

Healthy volunteersNot accepted

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.

•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 patient does not have recent 25(OH)D results, we will add this to the screening labs.

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.

•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 permissible)

•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 related to bone health. Rationale: DMPA has a well-documented deleterious effect on bone density, which could confound study outcomes related to bone health or metabolic parameters.

•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 if known positive antibodies. Patients with known hypothyroidism will be included if appropriately treated with levothyroxine and have a normal TSH. For patients with secondary hypothyroidism (deficient production of TSH from the pituitary gland causing hypothyroidism), normal free T4 concentrations (and not TSH alterations) will be used for study inclusion, and recent adjustments in the levothyroxine dose will be permissible as long as free T4 concentrations are in the normal range at dose adjustment (as dose adjustments are often made to get free T4 concentrations in the upper half of the normal range when assessed levels are in the lower half of the normal range). Patients with hyperthyroidism will be excluded given known deleterious effects on both weight and bone metabolism.

•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 spondylitis, untreated thyroid disease, and hypercortisolemia.

•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.

Endpoints (8)

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 clinical outcomes

Other (unclassified)

Weight & body composition

1 endpoint

Primary/protocol endpoint/low confidence

24-month change in total vBMD at the distal radius

Time frame:24 months