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:

Cohort I:

• Boys: Tanner stage 1 for pubic hair and testis volume below 4 ml , age at least 2years 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 atscreening

• Confirmed diagnosis of GHD (growth hormone deficiency) within 12 months prior toscreening 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 threeor 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 chronologicalage (CA) and gender according to the standards of Centers for Disease Control andPrevention 2-20 years: Girls/Boys stature-for-age and weight-for-age percentiles CDCat 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 tothe standards of Prader calculated over a time span of minimum 6 months and maximum 18 months

Cohort II:

• Below 2 years and 26 weeks and a minimum weight of 5 kg at screening.

• Confirmed diagnosis of GHD, the GHD diagnosis must be confirmed by investigatoraccording to local practice.

• For GH treatment naïve subjects, no prior exposure to GH therapy and/or IGF-Itreatment.

• For GH treatment naïve subjects, IGF-1 SDS below -1.0 at screening, compared to ageand sex normalized range according to central laboratory measurements.

Cohort III:

Age:

• Girls: Above 9.0 years and below or equal to 17.0 years at screening.

• Boys: Above 10.0 years and below or equal to 17.0 years at screening.

• Confirmed diagnosis of GHD

1. for GH treatment naïve subjects, confirmed diagnosis within 12 months prior toscreening as determined by two different GH stimulation tests, defined as apeak GH level of equal to or below 7.0 ng/ml. For children with three or morepituitary hormone deficiencies only one GH stimulation test is needed. FORJAPAN ONLY: Confirmed diagnosis of GHD within 12 months prior to screening asdetermined by one GH stimulation tests for patients with intracranial organicdisease or symptomatic hypoglycaemia and two different GH stimulation test forother patients, defined as a peak GH level of equal to or below 6 ng/ml byassay using recombinant GH standard.

2. for non-GH treatment naïve subjects, confirmed GHD diagnosis by investigatoraccording to local practice

• For GH treatment naïve subjects, no prior exposure to GH therapy and/or IGF-Itreatment.

• Open epiphyses; defined as bone age below 14 years for females and bone age below 16years for males.

Exclusion Criteria:

• Any clinically significant abnormality likely to affect growth or the ability toevaluate

• growth with standing/length measurements: Chromosomal aneuploidy and significantgene mutations causing medical "syndromes" with short stature, including but notlimited to Turner syndrome, Laron syndrome, Noonan syndrome, or absence of GHreceptors. Congenital abnormalities (causing skeletal abnormalities), including butnot limited to Russell-Silver Syndrome, skeletal dysplasias. Significant spinalabnormalities including but not limited to scoliosis, kyphosis and spina bifidavariants

• Children born small for gestational age (SGA - birth weight and/or birth lengthbelow-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 deficithyperactivity disorder (ADHD)

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