Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.

Inclusion criteria

• Diagnosis of SGA or ISS. SGA, defined as born with a birth weight and/or length <-2 SDS below the mean for gestational age. ISS, defined as height < -2 SDS for age and gender without evidence of GHD
• Females aged ≥3 years and <9 years. Males aged ≥3 years and <11 years
• Pre-pubertal- Tanner stage 1 for breasts and testes.
• A bone age of not more than chronological age recorded in previous 8 weeks.
• Current height < -2 SDS for age and gender.
• Participants using hormonal replacement therapy(s) must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion criteria

• History of cancer, radiation therapy or chemotherapy.
• History of GHD.
• Children who are small due to malnutrition, defined as a Z score of weight for height and/or BMI below -2 for age, according to national standards.
• History of HIV-positive, acquired immune deficiency syndrome (AIDS), hepatitis B, hepatitis C, or tuberculosis.
• Microcephaly (Head Circumference < -2 SDS)
• Any chronic disease or diagnosis, likely to affect growth, including but not limited to gastrointestinal disorder, celiac disease, untreated thyroid disease, diabetes mellitus and metabolic disorders.
• Known or suspected skeletal dysplasias
• Known or suspected chromosomal abnormalities
• IGF-1 >2 SDS
• Any disorder or condition which, in the opinion of the investigator, might jeopardize participant's safety or compliance with the protocol
• Prior exposure to growth promoting therapy
• Current use of any prohibited concomitant medication(s): Any rhGH or growth-promoting therapy, Any therapy that affects appetite or weight, Psychiatric medications associated with weight changes and/or diabetes, excluding medications used to treat ADHD, Any androgen or estrogen therapy including over the counter supplements, Systemic corticosteroids (inhaled or oral) exceeding the doses: Inhaled: > 400 μg/day of inhaled budesonide or equivalent. Oral: > 8 mg/m2/day of oral hydrocortisone or equivalent.
• Previous administration with an investigational drug within 90 days.
• Fasting blood glucose >126 mg/dL
• Renal impairment
• Hepatic dysfunction.
• Pregnancy
• Known hypersensitivity to the components of the study intervention