Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
Start Date
2/1/2026
Completion Date
1/1/2028
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.
Eligibility Criteria
Age Range: 3 years to 11 years
Interventions
Somatrogon
Genotropin
Conditions
Locations
University of California Los Angeles (UCLA) - Mattel Children's Hospital
Los Angeles, California 90095
United States
Rocky Mountain Pediatric Endocrinology
Centennial, Colorado 3433325
United States
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida 19803
United States
Children's Minnesota - Minneapolis
Minneapolis, Minnesota 55404
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Atlantic Health System
Morristown, New Jersey 07901
United States
Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey
New Brunswick, New Jersey 08901
United States
The State University of New York (SUNY) School of Medicine and Biomedical Sciences
Buffalo, New York 13210
United States
Hassenfeld Children's Hospital at NYU Langone
New York, New York 10016
United States
Dell Children's Medical Group
Austin, Texas 78723
United States
Cook Children's Medical Center
Fort Worth, Texas 76104
United States
The University of Utah
Salt Lake City, Utah 84112
United States
Centre Hospitalier Universitaire d'Angers
Angers,
France
Hôpital Bicêtre
Le Kremlin-Bicêtre,
France
Chu de Lyon - Hopital Femme Mere Enfant
Lyon,
France
CHU Hôpital de la Timone
Marseille,
France
Hôpital Armand-Trousseau
Paris,
France
Hôpital Necker - Enfants Malades
Paris,
France
Jehangir Hospital
Maheshra,
India
Apollo Hospitals Enterprise Limited
Navi Mumbai,
India
All India Institute of Medical Sciences (AIIMS) - New Delhi
New Delhi,
India
Sir Ganga Ram Hospital
New Delhi,
India
Schneider Children Medical Center- the institute of Endocrinology and Diabetes
Petah Tikva, Israel 4920235
Israel
Shaare Zedek Medical Center
Jerusalem, Israe 9103102
Israel
Soroka hospital
Bear Sheva,
Israel
Sheba Medical Center
Ramat Gan,
Israel
Assaf Harofe Medical Center
Rishon LeZiyyon,
Israel
Dana-Duek children's hospital
Tel Aviv,
Israel
Osaka Women's and Children's Hospital
Izumi-Shi,
Japan
Nara Prefecture General Medical Center
Nara,
Japan
Osaka City General Hospital
Osaka,
Japan
National Center for Child Health and Development
Setagaya-Ku,
Japan