Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study
Primary result · Height velocityResult — go to the resultEstimated treatment difference −0.3 cm/year 95% CI −1.00 to 0.42Authors' conclusion
Similar efficacy and safety were confirmed for once-weekly somapacitan versus daily GH in treatment-naïve children with ISS, with favourable patient-reported outcome measures, setting the ground for future treatment for ISS with a once-weekly option.
Study context
- Population
- Pre-pubertal, treatment-naive children with idiopathic short stature (ISS), clinics in 20 countries85 completed
- Participants
- 88 participants
- Comparison
- Once-weekly somapacitan vs daily growth hormone (GH)
Methodological detailsglobal, open-labelled, active-comparator, phase 3, basket study, 52-week main phase and 104-week extension
- Global
- Open-labelled
- Active-comparator
- Phase 3
- Basket study
- 52-week main phase and 104-week extension
Primary result
Height velocity · week 52
Estimated treatment difference
−0.3 cm/year
95% CI −1.00 to 0.42
By group
Somapacitanvs Daily GH
estimated treatment difference −0.3 cm/year (95% CI −1.00 to 0.42)
As reported in the abstract
Further findings
- Disease and treatment burden questionnaires presented favourable results
Safety
Adverse events
Events Somapacitan 191 · Daily GH 87
Adverse events
- Safety profiles similar; most adverse events (AEs) mild and unlikely related to study product
Original publication
Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study. Eur J Endocrinol. Published 19 February 2026. doi:10.
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