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

Recruiting now · Phase 3

Conditions studied: ISS, SGA

In brief

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 facts

Study ID

NCT07226089

Run by

Rabin Medical Center

People needed

254

Starts

2026-02-01

Expected to finish

2028-01-01

Last updated by the study team

2026-04-30

Who can join

Age: 3 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of SGA or ISS. SGA, defined as born with a birth weight and/or length <-2 SDS below the mean for gestational age. ISS, defined as height < -2 SDS for age and gender without evidence of GHD
• Females aged ≥3 years and <9 years. Males aged ≥3 years and <11 years
• Pre-pubertal- Tanner stage 1 for breasts and testes.
• A bone age of not more than chronological age recorded in previous 8 weeks.
• Current height < -2 SDS for age and gender.
• Participants using hormonal replacement therapy(s) must be on an optimized and stable treatment regimen (hormone levels within normal ranges on screening) for at least three months prior to screening
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if…

• History of cancer, radiation therapy or chemotherapy.
• History of GHD.
• Children who are small due to malnutrition, defined as a Z score of weight for height and/or BMI below -2 for age, according to national standards.
• History of HIV-positive, acquired immune deficiency syndrome (AIDS), hepatitis B, hepatitis C, or tuberculosis.
• Microcephaly (Head Circumference < -2 SDS)
• Any chronic disease or diagnosis, likely to affect growth, including but not limited to gastrointestinal disorder, celiac disease, untreated thyroid disease, diabetes mellitus and metabolic disorders.
• Known or suspected skeletal dysplasias
• Known or suspected chromosomal abnormalities
• IGF-1 >2 SDS
• Any disorder or condition which, in the opinion of the investigator, might jeopardize participant's safety or compliance with the protocol
• Prior exposure to growth promoting therapy
• Current use of any prohibited concomitant medication(s): Any rhGH or growth-promoting therapy, Any therapy that affects appetite or weight, Psychiatric medications associated with weight changes and/or diabetes, excluding medications used to treat ADHD, Any androgen or estrogen therapy including over the counter supplements, Systemic corticosteroids (inhaled or oral) exceeding the doses: Inhaled: > 400 μg/day of inhaled budesonide or equivalent. Oral: > 8 mg/m2/day of oral hydrocortisone or equivalent.
• Previous administration with an investigational drug within 90 days.
• Fasting blood glucose >126 mg/dL
• Renal impairment
• Hepatic dysfunction.
• Pregnancy
• Known hypersensitivity to the components of the study intervention

Where it is running

• Schneider Children Medical Center- the institute of Endocrinology and Diabetes — Petah Tikva, Israel, Israel (enrolling)
• Rocky Mountain Pediatric Endocrinology — Centennial, Colorado, United States
• Nemours Children's Clinic - Jacksonville — Jacksonville, Florida, United States
• Children's Minnesota - Minneapolis — Minneapolis, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Atlantic Health System — Morristown, New Jersey, United States
• Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey — New Brunswick, New Jersey, United States
• The State University of New York (SUNY) School of Medicine and Biomedical Sciences — Buffalo, New York, United States
• Hassenfeld Children's Hospital at NYU Langone — New York, New York, United States
• Dell Children's Medical Group — Austin, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• The University of Utah — Salt Lake City, Utah, 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
• Shaare Zedek Medical Center — Jerusalem, Israe, Israel
• Soroka hospital — Bear Sheva, Israel
• Sheba Medical Center — Ramat Gan, Israel

Full record on ClinicalTrials.gov

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