A Phase 3 interventional study of Somatrogon and Genotropin in ISS and SGA, sponsored by Rabin Medical Center. Recruiting at 32 sites in 5 countries. Open to participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Rabin Medical Center · Phase 3, Interventional, and Treatment
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.
Exclusion Criteria:
Somatrogon will be administered subcutaneously (s.c) once weekly using a multi dose disposable prefilled pen for single patient use intended for SC self injection.
Drug: Somatrogon
Genotropin will be administrated subcutaneously (s.c) daily using Genotropin Pen growth hormone delivery devices or Genotropin two chamber cartridges (will be supplied in their primary commercial packaging)
Drug: Genotropin
Once weekly Growth Hormone
Also known as: NGENLA 60mg SSOL 1x1.2mL PFP US
Daily Growth Hormone
Also known as: Genotropin PEN 12 1x U2 US
Annual Height Velocity
Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.
Time frame: • Annualized HV after 12 months of treatment
Height Velocity over time
Time frame: HV over 3, 6 and 9 months
height SDS
Changes in height Standard Deviation Score (SDS)
Time frame: 3, 6, 9 and 12 months
Bone maturation
Annual change in bone age measurements as per Gruelich-Pyle method
Time frame: at screening and after 12 months
Insulin-like Growth Factor-1 (IGF-1)
Via central lab analysis
Time frame: Screening and after 3, 6, 9 and 12 months
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS)
Via central lab analysis
Time frame: Baseline and at 12 months
change in health-related quality of life
Assessed by QoLISSY questionnaire
Time frame: baseline and after 12 months
IGFBP-3
Via central lab
Time frame: At baseline and after 12 months
Frequency of abnormal lab results in the Somatrogon arm
Time frame: At screening, baseline and after 1, 3, 6 ,9 and 12 months
SAE's in the Somatrogon arm
Time frame: At screening, baseline and after 1, 3, 6 ,9 and 12 months
AE's in the Somatrogon arm
Time frame: At screening, baseline and after 1, 3, 6 ,9 and 12 months
Plan to share: No — We would only share patient data with regulatory agencies that require the information.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rabin Medical Center