Somapacitan in children born small for gestational age: a randomized controlled phase 3 trial
Authors' conclusion
Somapacitan provides similar efficacy, safety, and tolerability as daily GH in short children born SGA after 52 weeks of treatment. Somapacitan may be an attractive alternative to daily GH in this population, reducing treatment burden to improve adherence and treatment outcomes.
Study context
- Population
- Prepubertal, treatment-naïve short children born small for gestational age (SGA), 78 sites across 26 countries140 completed
- Participants
- 142 participants
- Comparison
- Once-weekly somapacitan vs daily growth hormone (GH) 0.035 or 0.067 mg/kg/day
- Primary endpoint
- Estimated mean height velocity
- Follow-up
- Week 52
Methodological detailsmultinational, multicenter, open-labeled, active comparator, phase 3, basket study, SGA sub-study, noninferiority
- Multinational
- Multicenter
- Open-labeled
- Active comparator
- Phase 3
- Basket study
- SGA sub-study
- Noninferiority
Primary result
As reported in the abstract
ETD, cm/year (95% CI)
Somapacitanvs Daily GH 0.035 mg/kg/daynoninferiority and superiority demonstrated
1.6(0.91–2.23)
Somapacitanvs Daily GH 0.067 mg/kg/daynoninferiority confirmed
−0.1(−0.75 to 0.60)
Further findings
Disease and treatment burden · week 52
- Somapacitan reduced disease burden, as did daily GH 0.067 mg/kg/day; somapacitan was associated with reduced treatment burden
Safety
- Safety profiles were similar between treatment groups
Original publication
Somapacitan in children born small for gestational age: a randomized controlled phase 3 trial. Eur J Endocrinol. Published 5 March 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →