Efficacy, safety, and insulin-like growth factor I of weekly somapacitan in children with growth hormone deficiency: 3-year results from REAL4
Authors' conclusion
Sustained efficacy and tolerability were observed for continuous somapacitan treatment for 3 years, and for 2 years after the switching from daily GH treatment. HSDS in both groups was approaching mean mid-parental HSDS.
Study context
- Population
- Treatment-naïve children with GH deficiency (GHD)188 completed 3 years
- Participants
- 200 children
- Comparison
- Continuous somapacitan vs daily GH followed by somapacitan
Methodological detailsmulti-national, open-labelled, active-controlled, parallel-group, phase 3, 52-week main phase and 3-year safety extension
- Multi-national
- Open-labelled
- Active-controlled
- Parallel-group
- Phase 3
- 52-week main phase and 3-year safety extension
Primary result
As reported in the abstract
Height velocity (HV) between weeks 104 and 156 · week 156
Further findings
Mean
| Outcome | Soma/soma | Switch |
|---|---|---|
| Height SDS (HSDS) · week 156 | −0.95 (SD 0.98) | −1.08 (SD 0.93) |
- Height SDS (height SD score (HSDS)) — Approaching mean mid-parental HSDS (both groups)
- −0.74
Mean total IGF-I SDS · year 3
- Similar between groups and within normal range (−2.0 to +2.0)
Bioactive IGF-I and bioactive IGF-I to IGF-I ratio
- Similar between groups
Safety
Tolerability
- Somapacitan was well tolerated, with low proportions reporting injection-site reactions
Original publication
Efficacy, safety, and insulin-like growth factor I of weekly somapacitan in children with growth hormone deficiency: 3-year results from REAL4. Eur J Endocrinol. Published 22 May 2025. doi:10.
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