ISSPhase 3MISSIONNCT07226089
Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
A Phase 3 study testing Somatrogon and Genotropin in people with ISS and SGA, run by Rabin Medical Center at 32 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 11 years
- What is being tested?
- Somatrogon and Genotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 32 sitesin 5 countries
- Study dates
- 1 Feb 2026to Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
- Hepatic dysfunction.
- Pregnancy
- Known hypersensitivity to the components of the study intervention
Trial locations and contacts
32 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
32 sites in 5 countries
United States12 sites, 12 recruiting
- Not yet recruiting
Dell Children's Medical Group
Austin, Texas, 78723
Susan Nunez, snunez@sfcaustin.com
- Not yet recruiting
The State University of New York (SUNY) School of Medicine and Biomedical Sciences
Buffalo, New York, 13210
Teresa Quattrin, tquattrin@upa.chob.edu
- Not yet recruiting
Rocky Mountain Pediatric Endocrinology
Centennial, Colorado, 3433325
Aristides Maniatis, amaniatis@rmpedendo.com
- Not yet recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
Joel Steelman, joel.steelman@cookchildrens.org
- Not yet recruiting
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Steven Ghanny, sghanny@hackensackumc.org
- Not yet recruiting
Nemours Children's Clinic - Jacksonville
Jacksonville, Florida, 19803
Lournaris Torres-Santiago, lotorres@nemours.org
- Not yet recruiting
University of California Los Angeles (UCLA) - Mattel Children's Hospital
Los Angeles, California, 90095
Mitchell Geffner, Mgeffner@chla.usc.edu
- Not yet recruiting
Children's Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
Bradley Miller, mille685@umn.edu
- Not yet recruiting
Atlantic Health System
Morristown, New Jersey, 07901
Lawrence Silverman, Dr, lawrence.silverman@atlantichealth.org
- Not yet recruiting
Rutgers Robert Wood Johnson Medical School - The Child Heath Institute of New Jersey
New Brunswick, New Jersey, 08901
Ian Marshall, marshaia@rwjms.rutgers.edu
- Not yet recruiting
Hassenfeld Children's Hospital at NYU Langone
New York, New York, 10016
Emily Briedbart
- Not yet recruiting
The University of Utah
Salt Lake City, Utah, 84112
Scott Clemens, scott.clements@hsc.utah.edu
France6 sites, 6 recruiting
- Not yet recruiting
Centre Hospitalier Universitaire d'Angers
Angers
Regis Coutant, recoutant@chu-angers.fr
- Not yet recruiting
Hôpital Bicêtre
Le Kremlin-Bicêtre
Agnes Linglart, agnes.linglart@aphp.fr
- Not yet recruiting
Chu de Lyon - Hopital Femme Mere Enfant
Lyon
Marc Nicolino, marc.nicolino@chu-lyon.fr
- Not yet recruiting
CHU Hôpital de la Timone
Marseille
Rachel Reynaud, rachel.reynaud@ap-hm.fr
- Not yet recruiting
Hôpital Armand-Trousseau
Paris
Marie-Noelle Dufourg, marie-noelle.dufourg@aphp.fr
- Not yet recruiting
Hôpital Necker - Enfants Malades
Paris
Michel Polak, michel.polak@aphp.fr
Israel6 sites, 6 recruiting
- Not yet recruiting
Soroka hospital
Bear Sheva
Alon Haim, Prof, 972-8-6400624, alonhaim@clalit.org.il
- Not yet recruiting
Shaare Zedek Medical Center
Jerusalem, Israe, 9103102
Floris Levi- Khademi, Professor, florislevy@szmc.org.il
- Recruiting
Schneider Children Medical Center- the institute of Endocrinology and Diabetes
Petah Tikva, Israel, 4920235
Moshe Phillip, Professor, 972-54-479-5995, mosheph@clalit.org.il
- Not yet recruiting
Sheba Medical Center
Ramat Gan
Orit Hamiel, Prof, Orit.Hamiel@sheba.health.gov.il
- Not yet recruiting
Assaf Harofe Medical Center
Rishon LeZiyyon
Marianna Rachmiel, MD, Rmarianna@gmail.com
- Not yet recruiting
Dana-Duek children's hospital
Tel Aviv
Yael Lebenthal, Prof, 972-544642167, yaelleb@tlvmc.gov.il
India4 sites, 4 recruiting
- Not yet recruiting
Jehangir Hospital
Maheshra
Vaman Khadilkar, vamankhadilkar@gmail.com
- Not yet recruiting
Apollo Hospitals Enterprise Limited
Navi Mumbai
Prashant Patil, dr_prash4u@yahoo.com
- Not yet recruiting
All India Institute of Medical Sciences (AIIMS) - New Delhi
New Delhi
Rajesh Khadgawat, rajeshkhadgawat@hotmail.com
- Not yet recruiting
Sir Ganga Ram Hospital
New Delhi
Archana Arya, adayal35@hotmail.com
Japan4 sites, 4 recruiting
- Not yet recruiting
Osaka Women's and Children's Hospital
Izumi-Shi
Masanobu Kawai, kawaim@wch.opho.jp
- Not yet recruiting
Nara Prefecture General Medical Center
Nara
Sayaka Yoshida, drsayaka@nara-hp.jp
- Not yet recruiting
Osaka City General Hospital
Osaka
Jun Mori, jun1113@koto.kpu-m.ac.jp
- Not yet recruiting
National Center for Child Health and Development
Setagaya-Ku
Kenichi Kashimada, kashimada-k@ncchd.go.jp
About this study
Official title: 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.
- Being tested
- Somatrogon, Genotropin
- Keywords
- Growth hormone, Somatrogon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatrogonDrug
Also called NGENLA 60mg SSOL 1x1.2mL PFP US
Once weekly Growth Hormone
GenotropinDrug
Also called Genotropin PEN 12 1x U2 US
Daily Growth Hormone
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Drug: Genotropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: • Annualized HV after 12 months of treatment
Secondary outcomes (6)
Height Velocity over time
Measured: HV over 3, 6 and 9 months
height SDS
Changes in height Standard Deviation Score (SDS)
Measured: 3, 6, 9 and 12 months
Bone maturation
Annual change in bone age measurements as per Gruelich-Pyle method
Measured: at screening and after 12 months
Insulin-like Growth Factor-1 (IGF-1)
Via central lab analysis
Measured: Screening and after 3, 6, 9 and 12 months
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS)
Via central lab analysis
Measured: Baseline and at 12 months
change in health-related quality of life
Assessed by QoLISSY questionnaire
Measured: baseline and after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2025
- Study start1 Feb 2026
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ISSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Professor, Study director, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226089
- Sponsor's protocol ID
- 0081-24-RMC
- Acronym
- MISSION
- Status last verified
- Feb 2026
- First submitted
- 6 Nov 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: We would only share patient data with regulatory agencies that require the information.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Interventional Study: Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature Pediatric Patients Compared With Daily Growth Hormone
- ClinicalTrials.gov ID
- NCT07226089
- Acronym / sponsor ID
- MISSION / 0081-24-RMC
- Keywords
- Growth hormone, Somatrogon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Somatrogon | Experimental | Drug: SomatrogonSomatrogon will be administered subcutaneously (s.c) once weekly using a multi dose disposable prefilled pen for single patient use intended for SC self injection. |
| Genotropin | Active comparator | Drug: GenotropinGenotropin 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) |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomatrogonAlso: NGENLA 60mg SSOL 1x1.2mL PFP USOnce weekly Growth Hormone | Drug | Somatrogon |
| GenotropinAlso: Genotropin PEN 12 1x U2 USDaily Growth Hormone | Drug | Genotropin |
Primary outcome
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.
6 secondary outcomes
Height Velocity over time
Time frame: HV over 3, 6 and 9 months
height SDS
Time frame: 3, 6, 9 and 12 months
Bone maturation
Time frame: at screening and after 12 months
Insulin-like Growth Factor-1 (IGF-1)
Time frame: Screening and after 3, 6, 9 and 12 months
Insulin-like Growth Factor-1 (IGF-1) Standard Deviation Score (SDS)
Time frame: Baseline and at 12 months
change in health-related quality of life
Time frame: baseline and after 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No. We would only share patient data with regulatory agencies that require the information.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Moshe Phillip, Professor study director
Schneider Children's Medical Center
32 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Somatrogon and Genotropin in people with ISS and SGA, run by Rabin Medical Center at 32 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, France, Israel, India, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moshe Phillip, Professor (972-54-479-5995, mosheph@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual Height Velocity (time frame: • Annualized HV after 12 months of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.