ClinicalTrials.gg
RecruitingNCT07226089MISSIONUpdated Apr 30, 2026

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

A Phase 3 interventional study of Somatrogon and Genotropin in ISS and SGA, sponsored by Rabin Medical Center. Recruiting at 32 sites in 5 countries. Open to participants aged 3 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-04-30.

Sponsored by Rabin Medical Center · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 9 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
254
Allocation
Randomized
Ages
3 Years to 11 Years
Sex
All
01

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.

02

Conditions studied

  • ISS
  • SGA

Keywords

  • Growth hormone
  • Somatrogon
03

In context

Lead sponsor

Rabin Medical Center is the lead sponsor of 393 studies on the registry; 30 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 below -2 for age, according to national standards.
  4. History of -positive, acquired immune deficiency syndrome (AIDS), , , 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 (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 drug within 90 days.
  14. Fasting blood glucose >126 mg/dL
  15. Renal impairment
  16. Hepatic dysfunction.
  17. Pregnancy
  18. Known to the components of the study intervention
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
254 participants (estimated)

Study arms

  • Experimental
    Somatrogon

    Somatrogon will be administered subcutaneously (s.c) once weekly using a multi dose disposable prefilled pen for single patient use intended for SC self injection.

    Drug: Somatrogon

  • Active comparator
    Genotropin

    Genotropin will be administrated subcutaneously (s.c) daily using Genotropin Pen growth hormone delivery devices or Genotropin two chamber cartridges (will be supplied in their primary commercial packaging)

    Drug: Genotropin

Interventions

  • Once weekly Growth Hormone

    Also known as: NGENLA 60mg SSOL 1x1.2mL PFP US

  • Daily Growth Hormone

    Also known as: Genotropin PEN 12 1x U2 US

06

What researchers measure

Primary outcomes

  1. Annual Height Velocity

    Annual Height Velocity in cm. Annual Height Velocity at 12 months is based on the difference between the heights at 12 months and baseline.

    Time frame: • Annualized HV after 12 months of treatment

Secondary outcomes

  1. Height Velocity over time

    Time frame: HV over 3, 6 and 9 months

  2. height SDS

    Changes in height Standard Deviation Score (SDS)

    Time frame: 3, 6, 9 and 12 months

  3. Bone maturation

    Annual change in bone age measurements as per Gruelich-Pyle method

    Time frame: at screening and after 12 months

  4. Insulin-like Growth Factor-1 (IGF-1)

    Via central lab analysis

    Time frame: Screening and after 3, 6, 9 and 12 months

  5. Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS)

    Via central lab analysis

    Time frame: Baseline and at 12 months

  6. change in health-related quality of life

    Assessed by QoLISSY questionnaire

    Time frame: baseline and after 12 months

Other outcomes

  1. IGFBP-3

    Via central lab

    Time frame: At baseline and after 12 months

  2. Frequency of abnormal lab results in the Somatrogon arm

    Time frame: At screening, baseline and after 1, 3, 6 ,9 and 12 months

  3. SAE's in the Somatrogon arm

    Time frame: At screening, baseline and after 1, 3, 6 ,9 and 12 months

  4. AE's in the Somatrogon arm

    Time frame: At screening, baseline and after 1, 3, 6 ,9 and 12 months

07

Study locations

1 of 32 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — We would only share patient data with regulatory agencies that require the information.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Feb 2026 (actual). Primary completion is estimated for Dec 2027, 22 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2025
First posted
Nov 10, 2025
StartActual
Feb 1, 2026
Primary completionEst.
Dec 2027
CompletionEst.
Jan 2028
Last update
Apr 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07226089
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Nov 10, 2025
Start date
Feb 1, 2026
Primary completion
Dec 2027 (estimated)
Completion
Jan 2028 (estimated)
Last update
Apr 30, 2026

Study contacts

Moshe Phillip, Professor
Contact
mosheph@clalit.org.il
972-54-479-5995
Alona Hamou, MSc
Contact
alonah@clalit.org.il
972-54-595-0277
Moshe Phillip, Professor
study director · Schneider Children's Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Somatrogon

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