A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

Exclusion Criteria

• •1. Known or suspected hypersensitivity to study intervention(s) or related products.
• •2. Previous randomization into same sub-study in this study.
• •3. Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical study at the time of randomization.
• •4. Children with suspected or confirmed growth hormone deficiency according to local practice.
• •5. laboratory of
• •1. fasting plasma glucose above or equal to 126 mg/dL (7.0 mmol/L) or
• •2. HbA1c above or equal to 6.5%.
• •6. Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
• •7. Children requiring inhaled glucocorticoid therapy at a dose greater than 400 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.
• •8. Concomitant administration of other treatments that may have an effect on growth, e.g., but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder (ADHD).
• •9. Diagnosis of attention deficit hyperactivity disorder (ADHD).
• •10. History or known presence of any malignancy, intracranial tumour, or intracranial cyst.
• •11. History or known presence of active Hepatitis B or Hepatitis C (exceptions to this exclusion criterion is the presence of antibodies due to vaccination against Hepatitis B).
• •12. Any disorder, which in the investigator's opinion, might jeopardize participant's safety or compliance with the protocol.
• •13. The participant or the parent/legally acceptable representative is likely to be non-compliant in respect to study conduct, as judged by the investigator.
• •14. Current treatment with sex hormones or aromatase inhibitors.
• •15. Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements, such as, but not limited to:
• •1. Known family history of skeletal dysplasia.
• •2. Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
• •3. Any other disorder/condition that can cause short stature such as, but not limited to, psychosocial deprivation, nutritional disorders, chronic systemic illness and chronic renal disease.
• •Applicable to children with SGA:
• •1. TS (including mosaicism).
• •2. NS.
• •3. Hormonal deficiencies.
• •4. Children who are small due to malnutrition defined as -2 standard deviations according to standards. 0¬-5 years: weight for height on World Health Organization Multicentre Growth Reference Study 2006. Above 5 years: World Health Organization 2007 Body Mass Index.
• •5. 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.
• •Applicable to children with TS:
• •1. NS.
• •2. Mosaicism below 10%.
• •3. TS with Y-chromosome mosaicism where gonadectomy has not been performed.
• •4. NYHA class II or above or requiring medication for any heart condition.
• •5. Coeliac disease where participant is not stable on gluten free diet for the previous 12 months prior to screening.
• •Applicable to children with NS:
• •1. TS (including mosaicism).
• •2. Noonan-related disorders: 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. Molecular genetic panel testing results must be available prior to randomisation to exclude these.
• •3. Coeliac disease where participant is not stable on gluten free diet for the previous 12 months prior to screening.
• •Applicable to children with ISS:
• •1. TS (including mosaicism).
• •2. NS.
• •3. Hormonal deficiencies.
• •4. Born small for gestational age (defined as birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
• •5. 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.