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

Exclusion Criteria

• •Children with suspected or confirmed growth hormone deficiency according to local practice.
• •Children diagnosed with diabetes mellitus or screening values from the central laboratory.
• •Fasting plasma glucose above or equal to 126 milligrams per deciliter (mg/dL) \[7.0 millimoles per litre (mmol/L)\] or
• •Glycated hemoglobin (HbA1c) above or equal to 6.5%.
• •Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
• •Children requiring inhaled glucocorticoid therapy at a dose greater than 400 micrograms per day (µg/day) of inhaled budesonide or equivalent (i.e., 250 µg/day for fluticasone propionate) for longer than 4 consecutive weeks within the last 12 months 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 short stature 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, kyphosis and spina bifida variants.
• •Any other disorder that can cause short stature such as, but not limited to nutritional 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 any heart 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, kyphosis and spina bifida variants.
• •Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease.
• •Noonan-related disorders including but not limited to: Noonan syndrome with multiple lentigines (formerly called 'LEOPARD' syndrome), Noonan syndrome with loose anagen hair, 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, kyphosis and spina bifida variants.
• •Any other disorder that can cause short stature such as, but not limited to nutritional 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 SHOX gene analysis or absence of GH receptors.