Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or… (NCT07226089) | Clinical Trial Compass
RecruitingPhase 3
Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
United States254 participantsStarted 2026-02-01
Plain-language summary
This study is a randomized, open-label, active controlled, parallel group study comparing the efficacy and safety of once weekly Somatrogon to daily Growth Hormone (Genotropin) in pre-pubertal children with short stature either born Small for Gestational Age (SGA) or with Idiopathic Short Stature (ISS). The planned study duration is 12 months with a screening period of up to 30 days. The study will consist of two groups: 140 children with SGA who are naïve to GH treatment will be randomized 1:1 to receive either Somatrogon or Genotropin for 12 months. A second group will include 114 children with ISS who are naïve to GH treatment who will be randomized 1:1 to receive either Somatrogon or Genotropin for 12 months.
Who can participate
Age range3 Years – 11 Years
SexALL
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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.
What they're measuring
1
Annual Height Velocity
Timeframe: • Annualized HV after 12 months of treatment
✕. 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.