Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)

Inclusion Criteria: * Have an established diagnosis of idiopathic PGHD as determined by standard diagnostic criteria. Eligible subjects must be naïve-to-treatment and be prepubertal. * Morning cortisol ≥ 7 µg/dL or stimulated cortisol ≥ 14 µg/dL. * At Screening, be ≥ 3.0 years and ≤ 11.0 years for girls and ≤ 12.0 years for boys. * Have HT-SDS ≤ -2.0 or HT-SDS ≥ 2 SD below mean parental HT-SDS. * Have a baseline height velocity \< 5.5 cm/year based on at least 6 months of growth. * Have a bone age delayed by ≥ 6 months with respect to chronological age. * Have prepubertal status as evidenced by Tanner Stage I breast development in girls and testicular volume \< 4.0 mL in boys. * In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic testing results are available, they need to be negative. * Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 30 days prior to Day 1. Exclusion Criteria: * Any medical or genetic condition which, in the opinion of the Investigator or Medical Monitor (MM), can be an independent cause of short stature and/or limit the response to exogenous growth factor treatment. (Examples: diabetes, idiopathic short stature). * A medical or genetic condition that, in the opinion of the Investigator and/or MM, adds unwarranted risk to use of LUM-201 or rhGH. * Use of any medication that, in the opinion of the Investigator and/or MM, can independently cause short…