CClinicalTrials.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

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

Who can participate

Ages eligible
3 Years to 11 Years
Sexes eligible
All
Accepts 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

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
04

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

  • DrugSomatrogon

    Once weekly Growth Hormone

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

  • DrugGenotropin

    Daily Growth Hormone

    Also known as: Genotropin PEN 12 1x U2 US

05

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

06

Study locations

1 of 32 sites recruiting
  • University of California Los Angeles (UCLA) - Mattel Children's Hospital
    Los Angeles, California 90095, United States
    Not yet recruiting
  • Rocky Mountain Pediatric Endocrinology
    Centennial, Colorado 3433325, United States
    Not yet recruiting
  • Nemours Children's Clinic - Jacksonville
    Jacksonville, Florida 19803, United States
    Not yet recruiting
  • Children's Minnesota - Minneapolis
    Minneapolis, Minnesota 55404, United States
    Not yet recruiting
  • Hackensack University Medical Center
    Hackensack, New Jersey 07601, United States
    Not yet recruiting
  • Atlantic Health System
    Morristown, New Jersey 07901, United States
    Not yet recruiting
  • Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey
    New Brunswick, New Jersey 08901, United States
    Not yet recruiting
  • The State University of New York (SUNY) School of Medicine and Biomedical Sciences
    Buffalo, New York 13210, United States
    Not yet recruiting
  • Hassenfeld Children's Hospital at NYU Langone
    New York, New York 10016, United States
    • Emily Briedbart · Contact
    Not yet recruiting
  • Dell Children's Medical Group
    Austin, Texas 78723, United States
    Not yet recruiting
  • Cook Children's Medical Center
    Fort Worth, Texas 76104, United States
    Not yet recruiting
  • The University of Utah
    Salt Lake City, Utah 84112, United States
    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 4920235, Israel
    Recruiting
  • Shaare Zedek Medical Center
    Jerusalem, Israe 9103102, Israel
    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
07

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.

08

Registry details

Key details

Study ID
NCT07226089
Lead sponsor
Rabin Medical Center
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 ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion