Investigating Efficacy and Safety of Once-weekly NNC0195-0092 (Somapacitan) Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

Inclusion Criteria:

- Boys: Tanner stage 1 for pubic hair and testis volume below 4 ml , age at least 2
years and 26 weeks and below or equal to 10.0 years at screening

- Girls: Tanner stage 1 for breast development (no palpable glandular breast tissue) and
pubic hair, age at least 2 years and 26 weeks and below or equal to 9.0 years at
screening

- Confirmed diagnosis of GHD (growth hormone deficiency) within 12 months prior to
screening as determined by two different GH (growth hormone) stimulation tests,
defined as a peak GH level of below or equal to 7.0 ng/ml. For children with three or
more pituitary hormone deficiencies only one GH stimulation test is needed

- No prior exposure to GH therapy and/or IGF-I (insulin-like growth factor I) treatment

- Height of at least 2.0 standard deviations below the mean height for chronological age
(CA) and gender according to the standards of Centers for Disease Control and
Prevention 2-20 years: Girls/Boys stature-for-age and weight-for-age percentiles CDC
at screening

- Annualized height velocity (HV) below the 25th percentile for CA (chronological age)
and gender or below -0.7 SD (standard deviation) score for CA and sex, according to
the standards of Prader calculated over a time span of minimum 6 months and maximum 18
months

Exclusion Criteria:

- Any clinically significant abnormality likely to affect growth or the ability to
evaluate

- growth with standing measurements: Chromosomal aneuploidy and significant gene
mutations causing medical "syndromes" with short stature, including but not limited to
Turner syndrome, Laron syndrome, Noonan syndrome, or absence of GH receptors.
Congenital abnormalities (causing skeletal abnormalities), including but not limited
to Russell-Silver Syndrome, skeletal dysplasias. Significant spinal abnormalities
including but not limited to scoliosis, kyphosis and spina bifida variants

- Children born small for gestational age (SGA - birth weight and/or birth length
below-2 SD for gestational age)

- Concomitant administration of other treatments that may have an effect on growth,
including but not limited to methylphenidate for treatment of attention deficit
hyperactivity disorder (ADHD)

- Prior history or presence of malignancy and/or intracranial tumour