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

NCT ID: NCT07226089

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2028-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Somatrogon

Intervention Type: DRUG

Once weekly Growth Hormone

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)

Group Type: ACTIVE_COMPARATOR

Genotropin

Intervention Type: DRUG

Daily Growth Hormone

Interventions

Somatrogon

Once weekly Growth Hormone

Intervention Type: DRUG

Genotropin

Daily Growth Hormone

Intervention Type: DRUG

Other Intervention Names

NGENLA 60mg SSOL 1x1.2mL PFP US; Genotropin PEN 12 1x U2 US

Eligibility 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

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Rabin Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moshe Phillip, Professor

Role: STUDY_DIRECTOR

Schneider Children's Medical Center

Locations

Shaare Zedek Medical Center

Jerusalem, Israe, Israel

Soroka hospital

Bear Sheva, , Israel

Schneider Children Medical Center- the institute of Endocrinology and Diabetes

Petah Tikva, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Assaf Harofe Medical Center

Rishon LeZiyyon, , Israel

Dana-Duek children's hospital

Tel Aviv, , Israel

Countries

Israel

Central Contacts

Moshe Phillip, Professor

Role: CONTACT

Phone: 972-54-479-5995

Email: mosheph@clalit.org.il

Alona Hamou, MSc

Role: CONTACT

Phone: 972-54-595-0277

Email: alonah@clalit.org.il

Facility Contacts

Floris Levi- Khademi, Professor

Role: primary

Moshe Phillip, Professor

Role: primary

Other Identifiers

0081-24-RMC

Identifier Type: -

Identifier Source: org_study_id