BridgeMD
Comparison of weekly Somatrogon to daily Genotropin in children born small for gestational age or with idiopathic short stature.
EU CTIS ID: 2025-523832-38-00
What this study is testing
To demonstrate that treatment effect of weekly somatrogon is non-inferior to daily Genotropin
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- The participant has a diagnosis of SGA, defined as born with a birth weight and/or length <-2 SDS below the mean for gestational age (according to national standards).
- The participant has a diagnosis of ISS, defined as: height < -2 SDS for age and gender without evidence of GHD (has a peak GH level >10 ng/mL, performed up to 24 months prior to screening).
- For participants with SGA: • Pre-pubertal (Tanner stage 1 for breasts) females aged ≥4 years (EU) or ≥3 years (non-EU) and <9 years (8 years and 364 days) on the date of ICD signature. A bone age of not more than chronological age, recorded in previous 8 weeks. • Pre-pubertal (Tanner stage 1 for testes) males aged ≥4 years (EU) or ≥3 years (non-EU) and <11 years (10 years and 364 days) on the date of ICD signature. A bone age of not more than chronological age recorded in previous 8 weeks.
- For participants with ISS: • Pre-pubertal (Tanner stage 1 for breasts) females aged ≥4 years (EU) or ≥3 years (non-EU) and <9 years (8 years and 364 days) on the date of ICD signature. A bone age of not more than chronological age and not greater than 2 years under chronological age, recorded in previous 8 weeks. • Pre-pubertal (Tanner stage 1 for testes) males aged ≥4 years (EU) or ≥3 years (non-EU) and <11 years (10 years and 364 days) on the date of ICD signature. A bone age of not more than chronological age and not greater than 2 years under chronological age, recorded in previous 8 weeks.
- Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
You likely can't join if
- History of cancer, radiation therapy or chemotherapy.
- Psychosocial short stature
- Known or suspected chromosomal abnormalities including, Turner Syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, short stature homeobox (SHOX) mutations/deletions.
- Children with closed epiphyses
- History or known presence of any active intracranial tumours or intracranial cysts.
- Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions
See the full eligibility criteria
Who can join
- The participant has a diagnosis of SGA, defined as born with a birth weight and/or length <-2 SDS below the mean for gestational age (according to national standards).
- The participant has a diagnosis of ISS, defined as: height < -2 SDS for age and gender without evidence of GHD (has a peak GH level >10 ng/mL, performed up to 24 months prior to screening).
- For participants with SGA: • Pre-pubertal (Tanner stage 1 for breasts) females aged ≥4 years (EU) or ≥3 years (non-EU) and <9 years (8 years and 364 days) on the date of ICD signature. A bone age of not more than chronological age, recorded in previous 8 weeks. • Pre-pubertal (Tanner stage 1 for testes) males aged ≥4 years (EU) or ≥3 years (non-EU) and <11 years (10 years and 364 days) on the date of ICD signature. A bone age of not more than chronological age recorded in previous 8 weeks.
- For participants with ISS: • Pre-pubertal (Tanner stage 1 for breasts) females aged ≥4 years (EU) or ≥3 years (non-EU) and <9 years (8 years and 364 days) on the date of ICD signature. A bone age of not more than chronological age and not greater than 2 years under chronological age, recorded in previous 8 weeks. • Pre-pubertal (Tanner stage 1 for testes) males aged ≥4 years (EU) or ≥3 years (non-EU) and <11 years (10 years and 364 days) on the date of ICD signature. A bone age of not more than chronological age and not greater than 2 years under chronological age, recorded in previous 8 weeks.
- Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
What rules you out
- History of cancer, radiation therapy or chemotherapy.
- Psychosocial short stature
- Known or suspected chromosomal abnormalities including, Turner Syndrome, Laron syndrome, Noonan syndrome, Prader-Willi syndrome, Russell-Silver syndrome, short stature homeobox (SHOX) mutations/deletions.
- Children with closed epiphyses
- History or known presence of any active intracranial tumours or intracranial cysts.
- Patients with acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure or similar conditions
- Benign intracranial hypertension with papilledema
- Untreated hormonal deficiencies
- Type 2 diabetes, malignancies, chronic infections and other known causes for stunted growth
- 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
- 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, (including significant spinal abnormalities, but not limited to scoliosis, kyphosis and spina bifida variants).
The study team makes the final eligibility decision.
Where it's taking place
- India
- Israel
- Japan
- United States
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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include India; Israel; Japan; United States. 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 EU CTIS; the study team decides eligibility.