Somapacitan in Children Born Small for Gestational Age (SGA): 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study
Authors' conclusion
A sustained dose-dependent growth response was demonstrated for somapacitan after 52 weeks of treatment. Overall, somapacitan 0.24 mg/kg/week provides similar efficacy, safety, and tolerability, as well as comparable bioactive and total IGF-I response, as daily GH (0.067 mg/kg/day) in children born SGA.
Study context
- Population
- Growth hormone (GH)-treatment-naïve, prepubertal short children born SGA; 38 sites in 12 countries61 completed 52 weeks
- Participants
- 62 participants
- Comparison
- Once-weekly somapacitan vs daily GH
Methodological detailsmulticenter, open-label, phase 2, 26-week main phase, 26-week extension, ongoing 4-year safety extension
- Multicenter
- Open-label
- Phase 2
- 26-week main phase, 26-week extension, ongoing 4-year safety extension
Primary result
As reported in the abstract
Estimated mean height velocity · week 52
Further findings
Total IGF-I and peak IGF-I bioactivity
- Dose-dependent increases in total IGF-I and peak IGF-I bioactivity with both treatments; similar between comparator groups
Exposure-response modeling (somapacitan) · 52 weeks
- Highest efficacy with somapacitan 0.24 mg/kg/week
Safety
- Similar safety and tolerability across all groups
Original publication
Somapacitan in Children Born SGA: 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study. J Clin Endocrinol Metab. Published 13 September 2024. doi:10.
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