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

NCT07226089 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 0081-24-RMC
• Study Type: interventional
• Target: 254
• Locations: 5 countries
• Sites: 32

Brief 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.

Conditions

ISS; SGA

Keywords

Growth hormone; Somatrogon

Outcome Measures

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.

  • Annualized HV after 12 months of treatment

Secondary Outcomes (6)

• Height Velocity over time

  HV over 3, 6 and 9 months

• height SDS

  3, 6, 9 and 12 months

• Bone maturation

  at screening and after 12 months

• Insulin-like Growth Factor-1 (IGF-1)

  Screening and after 3, 6, 9 and 12 months

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

  Baseline and at 12 months

Other Outcomes (4)

• IGFBP-3

  At baseline and after 12 months

• Frequency of abnormal lab results in the Somatrogon arm

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

• SAE's in the Somatrogon arm

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

Study Arms (2)

Somatrogon

EXPERIMENTAL

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

Genotropin

ACTIVE COMPARATOR

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

Somatrogon DRUG

Once weekly Growth Hormone

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

Somatrogon

Genotropin DRUG

Daily Growth Hormone

Also known as: Genotropin PEN 12 1x U2 US

Genotropin

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• Females aged ≥3 years and \<9 years. Males aged ≥3 years and \<11 years
• Pre-pubertal- Tanner stage 1 for breasts and testes.
• A bone age of not more than chronological age recorded in previous 8 weeks.
• Current height \< -2 SDS for age and gender.
• 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
• Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• History of cancer, radiation therapy or chemotherapy.
• History of GHD.
• 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.
• History of HIV-positive, acquired immune deficiency syndrome (AIDS), hepatitis B, hepatitis C, or tuberculosis.
• Microcephaly (Head Circumference \< -2 SDS)
• 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.
• Known or suspected skeletal dysplasias
• Known or suspected chromosomal abnormalities
• IGF-1 \>2 SDS
• Any disorder or condition which, in the opinion of the investigator, might jeopardize participant's safety or compliance with the protocol
• Prior exposure to growth promoting therapy
• 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.
• Previous administration with an investigational drug within 90 days.
• Fasting blood glucose \>126 mg/dL
• Renal impairment

Sponsors & Collaborators

• Rabin Medical Center: lead
• Pfizer: collaborator

Study Sites (32)

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

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

MeSH Terms

Interventions

somatrogon; Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Moshe Phillip, Professor

  Schneider Children's Medical Center

  STUDY DIRECTOR

Central Study Contacts

Moshe Phillip, Professor

CONTACT

972-54-479-5995; mosheph@clalit.org.il

Alona Hamou, MSc

CONTACT

972-54-595-0277; alonah@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); JP (4); IN (4); FR (6); IL (6)