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)
Ibutamoren MesylateIbutamoren MesylateMatched placebo capsules administered orally once per dayIbutamoren Mesylate
Eligibility
Age group
0-17 years
Sex
Female, Male
Primary endpoint
AHV from Day 1 to Month 12 in the LUM-201 and placebo arms
Endpoint detail
• Change from baseline in IGF-1 SDS, • Change from baseline in HT-SDS, • Change from baseline in IGFBP-3 SDS, • IGF-1 SDS, • HT SDS, • IGFBP-3 SDS
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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