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Clinical Trials in India / NCT07226089
Recruiting Phase 3

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

NCT07226089 · tracked via the Priya Life Science India tracker
Sponsor
Rabin Medical Center
Phase
Phase 3
Started
2026-02-01
Last updated
2026-04-30

Condition(s) studied

ISSSGA

Investigational drug(s) / intervention(s)

SomatrogonGenotropin

Somatrogon: Once weekly Growth Hormone

Genotropin: Daily Growth Hormone

Study 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

Sex
ALL
Min age
3 Years
Max age
11 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (32)

FacilityCityRegionStatus
University of California Los Angeles (UCLA) - Mattel Children's Hospital Los Angeles California Not Yet Recruiting
Rocky Mountain Pediatric Endocrinology Centennial Colorado Not Yet Recruiting
Nemours Children's Clinic - Jacksonville Jacksonville Florida Not Yet Recruiting
Children's Minnesota - Minneapolis Minneapolis Minnesota Not Yet Recruiting
Hackensack University Medical Center Hackensack New Jersey Not Yet Recruiting
Atlantic Health System Morristown New Jersey Not Yet Recruiting
Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey New Brunswick New Jersey Not Yet Recruiting
The State University of New York (SUNY) School of Medicine and Biomedical Sciences Buffalo New York Not Yet Recruiting
Hassenfeld Children's Hospital at NYU Langone New York New York Not Yet Recruiting
Dell Children's Medical Group Austin Texas Not Yet Recruiting
Cook Children's Medical Center Fort Worth Texas Not Yet Recruiting
The University of Utah Salt Lake City Utah Not Yet Recruiting
Centre Hospitalier Universitaire d'Angers Angers France Not Yet Recruiting
Hôpital Bicêtre Le Kremlin-Bicêtre France Not Yet Recruiting
Chu de Lyon - Hopital Femme Mere Enfant Lyon France Not Yet Recruiting
CHU Hôpital de la Timone Marseille France Not Yet Recruiting
Hôpital Armand-Trousseau Paris France Not Yet Recruiting
Hôpital Necker - Enfants Malades Paris France Not Yet Recruiting
Jehangir Hospital Maheshra India Not Yet Recruiting
Apollo Hospitals Enterprise Limited Navi Mumbai India Not Yet Recruiting
All India Institute of Medical Sciences (AIIMS) - New Delhi New Delhi India Not Yet Recruiting
Sir Ganga Ram Hospital New Delhi India Not Yet Recruiting
Schneider Children Medical Center- the institute of Endocrinology and Diabetes Petah Tikva Israel Recruiting
Shaare Zedek Medical Center Jerusalem Israe Not Yet Recruiting
Soroka hospital Bear Sheva Israel Not Yet Recruiting
Sheba Medical Center Ramat Gan Israel Not Yet Recruiting
Assaf Harofe Medical Center Rishon LeZiyyon Israel Not Yet Recruiting
Dana-Duek children's hospital Tel Aviv Israel Not Yet Recruiting
Osaka Women's and Children's Hospital Izumi-Shi Japan Not Yet Recruiting
Nara Prefecture General Medical Center Nara Japan Not Yet Recruiting
Osaka City General Hospital Osaka Japan Not Yet Recruiting
National Center for Child Health and Development Setagaya-Ku Japan Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07226089 on ClinicalTrials.gov ↗ ← All trials in India