A Multicenter, 12-Month, Randomized, Double Blind, Placebo-Controlled Phase 3 Efficacy and Safety Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Growth Hormone Deficiency (GHD)
LUM-201-10
- Phase: III
- Clinicaltrials.gov ID: NCT06948214
What is the goal of the study?
LUM-201 is an oral drug that increases the amplitude of growth hormone (GH) pulsations over 24 hours, with subsequent increases from baseline in insulin-like growth factor 1 (IGF-1) and appears to produce a meaningful increase in growth in appropriately selected patients diagnosed with pediatric growth hormone deficiency (GHD). Based on results from the Phase 2 dose finding LUM-201-01 clinical trial, a dose of 1.6 mg/kg/day was selected as the optimal dose, increasing annualized height velocity (AHV) more than the lower dose of 0.8 mg/kg/day, but comparably to the higher dose of 3.2 mg/kg/day. The primary objective is to evaluate the effect of LUM-201 1.6 mg/kg/day on growth rates over 12 months in prepubertal children with GHD
Who can participate in the study?
Please contact the study team listed below to learn more.
Study Team:
- PI (Study Doctor): Patricia Fechner
- Study Team Member: Stephanie Purdy, [email protected]