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

Multicenter Interventional Study: Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature Pediatric Patients Compared With Daily Growth Hormone

Phase 3 Interventional Rabin Medical Center · NCT07226089

The study will test whether a once-weekly somatrogon injection works as well and is as safe as daily Genotropin for prepubertal children with short stature due to being born small for gestational age (SGA) or idiopathic short stature (ISS).

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment254 (estimated)
Ages3 Years to 11 Years
SexAll
SponsorRabin Medical Center Academic / other
Drugs / interventionschemotherapy, radiation
Locations32 sites (Los Angeles, California and 31 other locations)
Trial IDNCT07226089 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Prepubertal children aged 3–9 years (females) or 3–11 years (males) who are GH‑naïve with diagnosed SGA or ISS, height < -2 SDS, Tanner stage 1, and bone age not advanced beyond chronological age are ideal candidates.

Not a fit: Children with prior growth hormone treatment, diagnosed growth hormone deficiency, active or prior cancer, malnutrition-related short stature, pubertal development, or those outside the specified age range are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, once-weekly somatrogon could provide similar growth results with fewer injections, making treatment more convenient and potentially improving adherence for children and families.

How similar studies have performed: Earlier Phase 2/3 studies of weekly somatrogon formulations have shown promising efficacy and tolerability compared with daily growth hormone in children with GH-related short stature, supporting Phase 3 comparison.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Los Angeles, California and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ISSSGAGrowth hormoneSomatrogon
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.