NCT07226089

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

Multicenter Interventional Study: Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature Pediatric Patients Compared With Daily Growth Hormone

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (estimated)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ISS
• SGA

Interventions

Type	Name	Description
DRUG	Somatrogon	Once weekly Growth Hormone
DRUG	Genotropin	Daily Growth Hormone

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-12-01
• Completion: 2028-01-01
• First posted: 2025-11-10
• Last updated: 2026-02-24

Locations

6 sites across 1 country: Israel

Regulatory

• FDA-regulated drug study