Somapacitan in children born small for gestational age: 4-year results from phase 2
Authors' conclusion
These results support long-term continuous efficacy, safety, and tolerability of GH therapy with somapacitan 0.24 mg/kg/week for up to 4 years in children born SGA, including after switching from daily GH.
Study context
- Population
- Children born small for gestational age (SGA) with short stature, 38 clinics across 12 countries; 48 switched to somapacitan 0.24 mg/kg/week from daily growth hormone (GH) or lower somapacitan doses55 completed 208 weeks
- Participants
- 62 children
- Comparison
- Once-weekly somapacitan vs daily GH
Methodological detailsglobal, open-label, phase 2, 26-week main phase, 26-week extension I, ongoing 4-year extension II, 60 participants entered extension II
- Global
- Open-label
- Phase 2
- 26-week main phase, 26-week extension I, ongoing 4-year extension II
- 60 participants entered extension II
Primary result
As reported in the abstract
Height SD scores · week 52 to week 208
- Continuous increases in height SD scores across all treatment arms, including after switch to somapacitan 0.24 mg/kg/week
Further findings
Patient preference questionnaire
- Respondents preferring somapacitan over daily GH
- 87%
- Respondents expecting to be more adherent with somapacitan
- 80%
Safety
Safety and tolerability · week 52 to 208
- Safety and tolerability of somapacitan 0.24 mg/kg/week similar to the well-established profile of daily GH in SGA
Original publication
Somapacitan in children born small for gestational age: 4-year results from phase 2. Eur J Endocrinol. Published 30 January 2026. doi:10.
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