A Phase 2, Safety and Dose-Finding Study in Treatment-Naive, Pre-Pubertal, Growth Hormone-Deficient Children

Inclusion criteria

Criteria for Inclusion: * Pre-pubertal boys ≥ 3 years to ≤ 11 years and pre-pubertal girls ≥ 3 years to ≤ 10 years growth hormone (GH) insufficiency * Diagnosis criteria consistent with growth hormone research society consensus guidelines * Patients with a previously treated pituitary tumor must have no tumor progression for at least the past year * Physician determined rate of change in height less than 2 standard deviations per age group. * Written Informed Consent * Parent or legal guardian who is capable and willing to administer the study drug. * Other criteria apply, please contact the investigator for more information Criteria for Exclusion: * Any clinically significant medical condition as determined by the investigator, that is likely to affect growth * Contraindications to rhGH treatment; * History of or currently active malignancy, including pituitary tumors; * Bone age, greater than chronological age or greater than 9 for girls or greater than 10 for boys within 3 months of screening. * Patients with known diagnosis of diabetes or pre-diabetes * Growth altering medications * Allergies to the study medication components; * Participation in another investigational study within 30 days of screening * Any medical condition as judged by the investigator to interfere with patient participation or the objectives of the study * Other criteria apply, please contact the investigator for more information