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New treatment option for ISS
Official title Comparison of Weekly Somatrogon to Daily Genotropin in Children Born Small for Gestational Age or With Idiopathic Short Stature.
ClinicalTrials.gov ID: NCT07226089
What this study is testing
What is Somatrogon?
Somatrogon is an investigational medicine, given as an once-weekly, being studied as a potential treatment for iss.
Also referred to as NGENLA 60mg SSOL 1x1.2mL PFP US.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 11
You may be able to join 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...
- 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.
You likely can't join 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...
See the full eligibility criteria
- 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Centennial, Colorado, United States
- Jacksonville, Florida, United States
- Minneapolis, Minnesota, United States
- Hackensack, New Jersey, United States
- Morristown, New Jersey, United States
- New Brunswick, New Jersey, United States
- Buffalo, New York, United States
- New York, New York, United States
- Austin, Texas, United States
- Fort Worth, Texas, United States
- Salt Lake City, Utah, United States
- Angers, France
- Le Kremlin-Bicêtre, France
- Lyon, France
- Marseille, France
- Paris, France
- Maheshra, India
- Navi Mumbai, India
- New Delhi, India
+ 10 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 11 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Centennial, Colorado, United States; Jacksonville, Florida, United States; Minneapolis, Minnesota, United States; Hackensack, New Jersey, United States; Morristown, New Jersey, United States and 24 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.