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

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.

NCT Number	NCT07226089
Lead Sponsor	Rabin Medical Center Collaborators: Pfizer
Conditions	ISS, SGA
Enrollment	254 participants
Start Date	2026-02-01
Primary Completion	2027-12 (estimated)
Study Completion	2028-01 (estimated)
Updated on ClinicalTrials.gov	2026-04-30