A Study to Assess Growth in Children With Idiopathic Short Stature

Inclusion 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 tothe general population of the same age and sex, as calculated using the Centers forDisease 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 hGHtreatment.

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 informedconsent.

Exclusion Criteria:

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 iswell 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. For hGH naïve participants, historic stimulation test result with serum or plasma GHlevel greater than 10 μg/L or serum IGF-1 in the normal range for age (between -1.00SDs and +2.00 SDs).

5. For participants currently on hGH treatment, historic results before GH treatment ofstimulation test with serum or plasma GH level greater than 10 μg/L or serum IGF-1test between -1.00 SDs and +2.00 SDs.

6. Have received an investigational product (IP) or investigational medical device forany purpose within 6 months before the Screening visit. .