A Multicenter, 6-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2b Study of Daily Oral LUM-201 in Naive-to-Treatment, Prepubertal Children with Growth Hormone Deficiency (GHD)
This research study is studying LUM-201 as a possible treatment for Growth Hormone Deficiency (GHD) in pre-pubertal (before puberty) children. Lumos Pharma is sponsoring this research study. Your child is being asked to be in this study because she or he has been diagnosed to have growth hormone deficiency; and your child’s study doctor thinks that your child might be a good candidate for this study. Growth hormone deficiency can result in growth failure. One of the most visible signs of growth failure is a height that is much shorter than most other children of the same age. This is called short stature. However, some children can have growth failure even if they do not have short stature. The standard treatment for growth hormone deficiency is daily injections under the skin of recombinant human growth hormone (rhGH). This study seeks to see if oral LUM-201 at various doses may achieve similar catch-up growth compared to rhGH and provide a safe and effective oral treatment alternative to daily injections. LUM-201 is to be taken by mouth and it is thought that it can increase the body’s ability to release growth hormone.
Growth Hormone Deficiency
Catch-up growth, GHD, Growth hormone secretagogue, Height, LUM-201, Oral, PEM, PGHD, Predictive Enrichment Marker