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

Part of paid clinical trials in Los Angeles, California.

Sponsor: Rabin Medical Center
Study ID: NCT07226089
Phase: PHASE3
Status: Recruiting

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Conditions

Eligibility Criteria

Sex: ALL
Age: 3 Years - 11 Years
Healthy Volunteers: Not accepted

Interventions

Somatrogon — DRUG
Once weekly Growth Hormone
Genotropin — DRUG
Daily Growth Hormone

Study Details

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.

Key Dates

Start date: Feb 1, 2026
Status verified: Feb 2026
Primary completion: Dec 31, 2027
Completion: Jan 31, 2028

Study Design

Enrollment: 254 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: Somatrogon
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.
Active Comparator: Genotropin
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)

Primary Outcome Measure

Annual Height Velocity [ Time Frame: • Annualized HV after 12 months of treatment ]

Central Contacts

Moshe Phillip, Professor
972-54-479-5995
[email protected]
Alona Hamou, MSc
972-54-595-0277
[email protected]

Locations (12)

Facility	City	State	ZIP	Site coordinators
University of California Los Angeles (UCLA) - Mattel Children's Hospital	Los Angeles	California	90095	Mitchell Geffner [email protected]
Rocky Mountain Pediatric Endocrinology	Centennial	Colorado	3433325	Aristides Maniatis [email protected]
Nemours Children's Clinic - Jacksonville	Jacksonville	Florida	19803	Lournaris Torres-Santiago [email protected]
Children's Minnesota - Minneapolis	Minneapolis	Minnesota	55404	Bradley Miller [email protected]
Hackensack University Medical Center	Hackensack	New Jersey	07601	Steven Ghanny [email protected]
Atlantic Health System	Morristown	New Jersey	07901	Lawrence Silverman, Dr [email protected]
Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey	New Brunswick	New Jersey	08901	Ian Marshall [email protected]
The State University of New York (SUNY) School of Medicine and Biomedical Sciences	Buffalo	New York	13210	Teresa Quattrin [email protected]
Hassenfeld Children's Hospital at NYU Langone	New York	New York	10016	Emily Briedbart
Dell Children's Medical Group	Austin	Texas	78723	Susan Nunez [email protected]
Cook Children's Medical Center	Fort Worth	Texas	76104	Joel Steelman [email protected]
The University of Utah	Salt Lake City	Utah	84112	Scott Clemens [email protected]

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By research site

University of California Los Angeles (UCLA) - Mattel Children's Hospital· Los Angeles, CA Rocky Mountain Pediatric Endocrinology· Centennial, CO Nemours Children's Clinic - Jacksonville· Jacksonville, FL Children's Minnesota - Minneapolis· Minneapolis, MN Hackensack University Medical Center· Hackensack, NJ Atlantic Health System· Morristown, NJ