A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9

Inclusion Criteria:

Applicable to children with SGA:

• Born small for gestational age (birth length below -2 SDS OR birth weight below -2SDS OR both) (according to national standards).

• Age:

• Male participants: Age equal to or above 11.0 years and below 18.0 years atscreening.

• Female participants: Age equal to or above 10.0 years and below 18.0 years atscreening.

• Open epiphyses; defined as bone age less than (<) 14 years for females and bone age < 16 years for males.

• For Growth Hormone (GH) treatment naïve participants: Impaired height defined as atleast 2.5 standard deviations below the mean height for chronological age and sex atscreening according to the standards of Centers for Disease Control and Prevention.

Applicable to children with TS:

• Diagnosis of TS according to local clinical practice.

• Age:

• Female participants: Age equal to or above 10.0 years and below 18.0 years atscreening.

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

• For GH treatment naïve participants: Impaired height defined as at least 2.0standard deviation below the mean height for chronological age and sex at screeningaccording to the standards of Centers for Disease Control and Prevention.

• For GH treatment naïve participants: Confirmed diagnosis of TS by 30-cell (or more)lymphocyte chromosomal analysis or confirmation of TS and TS mosaicism usingcomparative genomic hybridization (CGH)-array.

Applicable to children with NS:

• Diagnosis of NS according to local clinical practice.

• Age:

• Male participants: Age equal to or above 11.0 years and below 18.0 years atscreening.

• Female participants: Age equal to or above 10.0 years and below 18.0 years atscreening.

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

• For GH treatment naïve participants: Clinical diagnosis of NS according to van derBurgt score list and genetic test result or confirmed mutation in any of the genesassociated with NS before allocation.

Applicable to children with ISS:

• Age:

• Male participants: Age equal to or above 11.0 years and below 18.0 years atscreening.

• Female participants: Age equal to or above 10.0 years and below 18.0 years atscreening.

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

• For GH treatment naïve participants: Impaired height defined as at least 2.5standard deviations below the mean height for chronological age and sex at screening

• For GH treatment naïve participants: Normal GH secretion (GH peak above 7 ng/mL)during GH stimulation test performed within 18 months prior to screening.

• For GH treatment naïve participants: Bone age not delayed more than 2 years comparedto chronological age at screening.

Exclusion Criteria:

• Children with suspected or confirmed growth hormone deficiency according to localpractice.

• Children diagnosed with diabetes mellitus or screening values from the centrallaboratory.

• Fasting plasma glucose above or equal to 126 milligrams per deciliter (mg/dL) [7.0millimoles per litre (mmol/L)] or

• Glycated hemoglobin (HbA1c) above or equal to 6.5%.

• Current inflammatory diseases requiring systemic corticosteroid treatment for longerthan 2 consecutive weeks within the last 3 months prior to screening.

• Children requiring inhaled glucocorticoid therapy at a dose greater than 400micrograms per day (µg/day) of inhaled budesonide or equivalent (i.e., 250 µg/dayfor fluticasone propionate) for longer than 4 consecutive weeks within the last 12months prior to screening.

• History or known presence of malignancy including intracranial tumours.

Applicable to children with SGA:

• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:

• Poorly controlled or uncontrolled hormonal deficiencies.

• Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome,Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal shortstature homeobox (SHOX) gene analysis or absence of GH receptors.

Applicable to children with TS:

• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:

• Known family history of skeletal dysplasia.

• Significant spinal abnormalities including but not limited to scoliosis, kyphosisand spina bifida variants.

• Any other disorder that can cause short stature such as, but not limited tonutritional disorders, chronic systemic illness and chronic renal disease.

• Mosaicism below 10%.

• TS with Y-chromosome mosaicism where gonadectomy has not been performed.

• New York Heart Association (NYHA) class II or above or requiring medication for anyheart condition.

Applicable to children with NS:

• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:

• Known family history of skeletal dysplasia.

• Significant spinal abnormalities including but not limited to scoliosis, kyphosisand spina bifida variants.

• Any other disorder that can cause short stature such as, but not limited tonutritional disorders, chronic systemic illness and chronic renal disease.

• Noonan-related disorders including but not limited to: Noonan syndrome with multiplelentigines (formerly called 'LEOPARD' syndrome), Noonan syndrome with loose anagenhair, cardiofaciocutaneous syndrome (CFC), Costello syndrome, neurofibromatosis type 1 (NF1) and Legius syndrome.

Applicable to children with ISS:

• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:

• Known family history of skeletal dysplasia.

• Significant spinal abnormalities including but not limited to scoliosis, kyphosisand spina bifida variants.

• Any other disorder that can cause short stature such as, but not limited tonutritional disorders, chronic systemic illness and chronic renal disease.

• Poorly controlled or uncontrolled hormonal deficiencies.

• Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome,Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal SHOXgene analysis or absence of GH receptors.