Efficacy and Safety of Somapacitan versus Daily Growth Hormone in Children with Growth Hormone Deficiency: A Pooled Analysis of Randomised Trial Data
Authors' conclusion
In this pooled analysis of clinical trial data, somapacitan demonstrated similar efficacy and safety to daily GH for up to 156 weeks of treatment. A dose of 0.16 mg/kg/week of somapacitan was able to maintain consistent growth in children and adolescents who reached puberty.
Study context
- Population
- Children with GHD in the REAL 3, REAL 4 and REAL 6 trials
- Comparison
- Once-weekly somapacitan vs daily growth hormone (GH)
- Outcome
- HV
- Follow-up
- Week 52
Methodological detailsREAL 3, REAL 4 and REAL 6
- REAL 3, REAL 4 and REAL 6
Pooled result
As reported in the abstract
- Height velocity (HV) similar with somapacitan and daily GH
Further pooled results
HV · week 156
HV in pubertal children by Tanner stage · up to 130 weeks
- HV remained stable and was similar across treatment groups and Tanner stages
Safety
- Most adverse events (AEs) were mild and unlikely to be treatment-related
Original publication
Efficacy and Safety of Somapacitan versus Daily Growth Hormone in Children with Growth Hormone Deficiency: A Pooled Analysis of Randomised Trial Data. Horm Res Paediatr. Published 25 June 2026. doi:10. 1159/ 000553101
Composed by AI from the published abstract and checked against it. How Briefs are made →