Pediatric endocrinology

Efficacy and Safety of Somapacitan versus Daily Growth Hormone in Children with Growth Hormone Deficiency: A Pooled Analysis of Randomised Trial Data

Horm Res PaediatrPublished Pooled analysis of randomised trials

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

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