A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.

Exclusion Criteria

• •Known or suspected hypersensitivity to trial product(s) or related products.
• •Previous participation in this trial. Participation is defined as randomisation.
• •Receipt of any investigational medicinal product within 3 months before screening or participation in another clinical trial before randomisation
• •Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements:
• •Turner Syndrome (including mosaicisms)
• •Chromosomal aneuploidy and significant gene mutations causing medical "syndromes" with short stature, including but not limited to Laron syndrome, Noonan syndrome, Prader-Willi Syndrome, abnormal SHOX-1 gene analysis or absence of GH receptors
• •Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants
• •Congenital abnormalities (causing skeletal abnormalities), including but not limited to Russell-Silver Syndrome or skeletal dysplasias
• •Family history of skeletal dysplasia
• •Children born small for gestational age (birth weight 10th percentile of the recommended gender-specific birth weight for gestational age according to national standards in China5
• •Children diagnosed with diabetes mellitus or screening values from central laboratory of
• •1. fasting plasma glucose more than or equal to 126 mg/dl (7.0 mmol/L) or
• •2. HbA1c more than 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 µg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening
• •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)
• •Diagnosis of attention deficit hyperactivity disorder
• •Prior history or presence of malignancy including intracranial tumours
• •Prior 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)
• •Any clinically significant abnormal laboratory screening tests, as judged by the study doctor
• •Any disorder which, in the opinion of the study doctor, might jeopardise Participant's safety or compliance with the protocol
• •The participant or the parent/legally acceptable representative is likely to be non-compliant in respect to trial conduct, as judged by the study doctor
• •Children with hypothyroidism and/or adrenal insufficiency not on adequate and stable replacement therapy for at least 90 days prior to randomisation.