A Study to Assess Growth in Children with Idiopathic Short Stature

Eligibility Criteria

• 1. Participants must be \> 2 years old, and ≤ 14 years old (female) or ≤ 16 years old (males) at the time of signing the informed consent.
• 2. A height assessment corresponding to a height Z-score of ≤ -2.25 SDs in reference to the general population of the same age and sex, as calculated using the Centers for Disease Control and Prevention (CDC) growth chart (https://www.cdc.gov/growthcharts/zscore.htm).
• 3. Participants who have either never received hGH, or who are currently receiving hGH treatment.
• 4. Historic stimulation test result with serum or plasma GH level greater than 10 μg/L.
• 5. Parent(s) or guardian(s) are willing and able to provide written, signed informed consent.
• 1. Diagnosis of systemic disease or condition that may cause short stature, eg renal, neoplastic, pulmonary, cardiac, gastrointestinal, immunologic and metabolic disease. Children with such diagnoses can be considered for inclusion if their condition is well controlled, at the discretion of the Medical Monitor.
• 2. Known presence of one or more pituitary hormone deficiencies
• 3. Bone age advanced over chronological age by more than 3 years.
• 4. Known chromosomal imbalance or genetic variant causing short stature syndrome, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, Turner syndrome, disproportionate skeletal dysplasias, abnormal SHOX gene analysis, or Rasopathy (including Noonan syndrome).
• 5. Have received an investigational product (IP) or investigational medical device for any purpose within 6 months before the Screening visit. .