IMPE Abstracts

Background: Childhood obesity is associated with an increased risk of central precocious puberty (CPP).1 Thus, data on whether weight status affects the treatment of children with CPP would be valuable to help clinicians ensure proper management. Gonadotropin-releasing hormone agonists (GnRHa) are the gold-standard treatment for CPP.2 We present secondary analyses of hormone pubertal suppression data from the pivotal trial of the first small-volume, long-acting, subcutaneously administered GnRHa for CPP, with the goal of assessing whether the study drug effectively treats overweight children.

Methods: Children with treatment-naïve CPP received 2 doses of 45 mg subcutaneous leuprolide acetate at 24-week intervals over the 48-week study period. The BMI percentile for children is calculated based on the Center for Disease Control (CDC) growth charts, accounting for height, weight, age, and gender. Luteinizing hormone concentrations were assessed using a validated central Cobas ECLIA assay with a lower limit of detection of 0.100 IU/L. Estradiol (E2) concentrations were assessed using liquid chromatography-tandem mass spectrometry/mass spectrometry (LC-MS/MS) with a lower limit of detection of 10 pg/mL.

Results: Of the 62 total children (60 girls, 2 boys), 22 girls had BMI ≥ the 85^th percentile at baseline. In all of these girls, hormonal and pubertal suppression was achieved during the treatment period. The mean peak GnRH-stimulated LH decreased from 23.5 IU/L at screening/baseline to 1.9 IU/L at both week 24 and 48. The mean estradiol was 22.9, 10.2, and 10.9 at screening/baseline, week 24, and week 48, respectively.

Conclusion: In girls who were overweight at baseline, LH and E2 were suppressed to very low concentrations by week 48. Consistent with results from studies of other GnRHa therapies3, these data indicate that FENSOLVI effectively treats CPP in overweight children. Clinicians should consider providing counseling and intervention on healthy diets and lifestyles to children with above-normal BMI and their caregivers.