PubMed tag: none · 2026
Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study.
Abuzzahab et al. 2026European journal of endocrinology
PMID 41712606DOI 10.1093/ejendo/lvag027PUB-41712606
Trial · Interventional
Active, not recruitingPhase 3Registry dataShort name REAL 8
United States, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, Poland, Portugal, Saudi Arabia, Serbia, Slovenia, South Africa, South Korea, Spain
1 trial · 1 ongoing
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The study compares two medicines for treatment of children born small and who stay small, or with Turner Syndrome, Noonan Syndrome, or idiopathic short stature. The purpose of the study is to see how well treatment with somapacitan works compared to treatment with Norditropin®. Somapacitan is a new medicine, and Norditropin® is a medicine doctors can already prescribe in some countries. The study will last for upto 5.5 years. The participants will either get somapacitan once a week up to 5.5 years or Norditropin® once a day for 1 year followed by somapacitan once a week for up to 4.5 years. Which treatment the participants get is decided by chance.
Experimental
Somapacitan
Participants will receive Somapacitan for 273 weeks
Active comparator
Norditropin®
Participants will receive Norditropin® for 52 weeks (main treatment period) and Somapacitan for 221 weeks (extension period)
Outcomes the sponsor listed as primary.
Height velocity reported separately for small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS) and idiopathic short stature (ISS)
Time frame · From baseline (week 0) to visit 7 (week 52)
Measured in centimeter per year (cm/year)
Change in Height standard deviation scores (SDS) reported separately for SGA, TS, NS and ISS
Time frame · From baseline (week 0) to visit 7 (week 52)
Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in Height Velocity SDS reported separately for SGA, TS, NS and ISS
Time frame · From baseline (week 0) to visit 7 (week 52)
Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in bone age reported separately for SGA, TS and NS
Time frame · From baseline (week 0) to visit 7 (week 52)
Measured in ratio
Change in bone age for ISS
Time frame · From screening (visit 1) to visit 7 (week 52)
Measured in ratio
Change in insulin-like growth factor 1 (IGF-1) SDS reported separately for SGA, TS, NA and ISS
Time frame · From baseline (week 0) to visit 7 (week 52).
Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in insulin-like growth factor binding protein-3 (IGFBP-3) SDS reported separately for SGA, TS, NA and ISS
Time frame · From baseline (week 0) to visit 7 (week 52).
Measured in score. Positive score indicates that the value is closer to or above the reference population compared to baseline.
Change in fasting plasma glucose reported separately for SGA, TS, NS and ISS
Time frame · From screening (visit 1) to visit 7 (week 52)
Measured in millimoles per litre (mmol/L)
Change in homeostatic model assessment-B (HOMA-B) reported separately for SGA, TS, NS and ISS
Time frame · From screening (visit 1) to visit 7 (week 52)
Measured in percentage (%)
Change in homeostatic model assessment of insulin resistance (HOMAIR) reported separately for SGA, TS, NS and ISS
Time frame · From screening (visit 1) to visit 7 (week 52)
Measured in %
Change in glycated haemoglobin (HbA1c) reported separately for SGA, TS, NS and ISS
Time frame · From screening (visit 1) to visit 7 (week 52)
Measured in percentage of HbA1c
Weekly average somapacitan concentration (Cavg) based on population PK analysis
Time frame · From visit 3 (week 4) to visit 7 (week 52)
Measured in nanograms per milliliter (ng/mL)
Change in fasting plasma glucose reported separately for SGA, TS, NS and ISS
Time frame · From screening (visit 1) to visit 15 (week 156)
Measured in mmol/L
Change in homeostatic model assessment-B (HOMA-B) reported separately for SGA, TS, NS and ISS
Time frame · From screening (visit 1) to visit 15 (week 156)
Measured in %
Change in homeostatic model assessment of insulin resistance (HOMA-IR) reported separately for SGA, TS, NS and ISS
Time frame · From screening (visit 1) to visit 15 (week 156)
Measured in %
Change in glycated haemoglobin (HbA1c) reported separately for SGA, TS, NS and ISS
Time frame · From screening (visit 1) to visit 15 (week 156)
Measured in percentage of HbA1c
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
2 studies on this page
PubMed tag: none · 2026
Abuzzahab et al. 2026European journal of endocrinology
PMID 41712606DOI 10.1093/ejendo/lvag027PUB-41712606
Indexing hint: Randomized controlled trial · 2026
Jorge et al. 2026European journal of endocrinologycited by 1
PMID 41774755DOI 10.1093/ejendo/lvag041PUB-41774755
Who could join, as posted.
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