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

April 29, 2026 updated by: Rabin Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
254

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • Not yet recruiting
        • Centre Hospitalier Universitaire d'Angers
        • Contact:
      • Le Kremlin-Bicêtre, France
      • Lyon, France
      • Marseille, France
      • Paris, France
        • Not yet recruiting
        • Hôpital Necker - Enfants Malades
        • Contact:
      • Paris, France
  • India
      • Maheshra, India
      • Navi Mumbai, India
        • Not yet recruiting
        • Apollo Hospitals Enterprise Limited
        • Contact:
      • New Delhi, India
      • New Delhi, India
        • Not yet recruiting
        • All India Institute of Medical Sciences (AIIMS) - New Delhi
        • Contact:
  • Israel
      • Bear Sheva, Israel
        • Not yet recruiting
        • Soroka Hospital
        • Contact:
      • Ramat Gan, Israel
      • Rishon LeZiyyon, Israel
        • Not yet recruiting
        • Assaf Harofe Medical Center
        • Contact:
      • Tel Aviv, Israel
        • Not yet recruiting
        • Dana-Duek children's hospital
        • Contact:
    • Israe
      • Jerusalem, Israe, Israel, 9103102
        • Not yet recruiting
        • Shaare Zedek Medical Center
        • Contact:
    • Israel
      • Petah Tikva, Israel, Israel, 4920235
        • Recruiting
        • Schneider Children Medical Center- the institute of Endocrinology and Diabetes
        • Contact:
  • Japan
      • Izumi-Shi, Japan
        • Not yet recruiting
        • Osaka Women's and Children's Hospital
        • Contact:
      • Nara, Japan
        • Not yet recruiting
        • Nara Prefecture General Medical Center
        • Contact:
      • Osaka, Japan
      • Setagaya-Ku, Japan
        • Not yet recruiting
        • National Center for Child Health and Development
        • Contact:
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Not yet recruiting
        • University of California Los Angeles (UCLA) - Mattel Children's Hospital
        • Contact:
    • Colorado
      • Centennial, Colorado, United States, 3433325
        • Not yet recruiting
        • Rocky Mountain Pediatric Endocrinology
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 19803
        • Not yet recruiting
        • Nemours Children's Clinic - Jacksonville
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Not yet recruiting
        • Children's Minnesota - Minneapolis
        • Contact:
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
      • Morristown, New Jersey, United States, 07901
      • New Brunswick, New Jersey, United States, 08901
        • Not yet recruiting
        • Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey
        • Contact:
    • New York
      • Buffalo, New York, United States, 13210
        • Not yet recruiting
        • The State University of New York (SUNY) School of Medicine and Biomedical Sciences
        • Contact:
      • New York, New York, United States, 10016
        • Not yet recruiting
        • Hassenfeld Children's Hospital at NYU Langone
        • Contact:
          • Emily Briedbart
    • Texas
      • Austin, Texas, United States, 78723
      • Fort Worth, Texas, United States, 76104
    • Utah
      • Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Once weekly Growth Hormone
Other Names:
  • NGENLA 60mg SSOL 1x1.2mL PFP US
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
Daily Growth Hormone
Other Names:
  • Genotropin PEN 12 1x U2 US

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Annual Height Velocity
Time Frame: • Annualized HV after 12 months of treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS)
Time Frame: Baseline and at 12 months
Via central lab analysis
Baseline and at 12 months
height SDS
Time Frame: 3, 6, 9 and 12 months
Changes in height Standard Deviation Score (SDS)
3, 6, 9 and 12 months
Bone maturation
Time Frame: at screening and after 12 months
Annual change in bone age measurements as per Gruelich-Pyle method
at screening and after 12 months
Insulin-like Growth Factor-1 (IGF-1)
Time Frame: Screening and after 3, 6, 9 and 12 months
Via central lab analysis
Screening and after 3, 6, 9 and 12 months
change in health-related quality of life
Time Frame: baseline and after 12 months
Assessed by QoLISSY questionnaire
baseline and after 12 months
Height Velocity over time
Time Frame: HV over 3, 6 and 9 months
HV over 3, 6 and 9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
IGFBP-3
Time Frame: At baseline and after 12 months
Via central lab
At baseline and after 12 months
Frequency of abnormal lab results in the Somatrogon arm
Time Frame: At screening, baseline and after 1, 3, 6 ,9 and 12 months
At screening, baseline and after 1, 3, 6 ,9 and 12 months
SAE's in the Somatrogon arm
Time Frame: At screening, baseline and after 1, 3, 6 ,9 and 12 months
At screening, baseline and after 1, 3, 6 ,9 and 12 months
AE's in the Somatrogon arm
Time Frame: At screening, baseline and after 1, 3, 6 ,9 and 12 months
At screening, baseline and after 1, 3, 6 ,9 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rabin Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Moshe Phillip, Professor, Schneider Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 10, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0081-24-RMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We would only share patient data with regulatory agencies that require the information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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