Once-weekly somatrogon versus daily growth hormone for children with short stature (SGA or ISS)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label, active-controlled, parallel-group Phase 3 trial compares once-weekly somatrogon with daily Genotropin over 12 months in prepubertal children with SGA or ISS. Two GH‑naïve cohorts will be enrolled: 140 children with SGA and 114 children with ISS, each randomized 1:1 to receive somatrogon or Genotropin. Participants must meet age, Tanner stage, height SDS, and bone-age criteria and will attend regular clinic visits for dosing, growth measurements, and safety labs. The study measures growth response and safety/tolerability over the 12-month treatment period.

Why it matters

Who can join: the full rules

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

Where it's running

• Schneider Children Medical Center- the institute of Endocrinology and Diabetes
  Petah Tikva, Israel, Israel Recruiting
• University of California Los Angeles (UCLA) - Mattel Children's Hospital
  Los Angeles, California, United States Not yet recruiting
• Rocky Mountain Pediatric Endocrinology
  Centennial, Colorado, United States Not yet recruiting
• Nemours Children's Clinic - Jacksonville
  Jacksonville, Florida, United States Not yet recruiting
• Children's Minnesota - Minneapolis
  Minneapolis, Minnesota, United States Not yet recruiting
• Hackensack University Medical Center
  Hackensack, New Jersey, United States Not yet recruiting

Study contacts

• Study coordinator: Moshe Phillip, Professor
• Email: mosheph@clalit.org.il
• Phone: 972-54-479-5995

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.