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NCT07226089PHASE3Recruiting

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

Rabin Medical Center

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

Inclusion Criteria: 1. 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 2. Females aged ≥3 years and \<9 years. Males aged ≥3 years and \<11 years 3. Pre-pubertal- Tanner stage 1 for breasts and testes. 4. A bone age of not more than chronological age recorded in previous 8 weeks. 5. Current height \< -2 SDS for age and gender. 6. 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 7. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Exclusion Criteria: 1. History of cancer, radiation therapy or chemotherapy. 2. History of GHD. 3. 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. 4. History of HIV-positive, acquired immune deficiency syndrome (AIDS), hepatitis B, hepatitis C, or tuberculosis. 5. Microcephaly (Head Circumference \< -2 SDS) 6. 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. 7. Known or suspected skeletal dysplasias 8. Known or suspected chromosomal abnormalities 9. IGF-1 \>2 SDS 10. Any disorder or condition which, in the opinion of the investigator, might jeopardize participant's safety or compliance with the protocol 11. Prior exposure to growth promoting therapy 12. 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. 13. Previous administration with an investigational drug within 90 days. 14. Fasting blood glucose \>126 mg/dL 15. Renal impairment 16. Hepatic dysfunction. 17. Pregnancy 18. Known hypersensitivity to the components of the study intervention

Interventions

DRUG

Somatrogon

DRUG

Genotropin

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Conditions

ISSSGA

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