Extension of the Phase 3 Trial of Somatrogon in Children with Growth Hormone Deficiency: 3 Years of Safety and Efficacy
Authors' conclusion
Following up to 3 years of somatrogon treatment, children with GHD showed a persistent increase in linear growth velocity compared to baseline. Somatrogon was well tolerated, with no new safety signals identified.
Study context
- Population
- Children with growth hormone deficiency (GHD) who completed the 12-month main study212 entered open-label extension (OLE) Y1, 177 OLE Y2
- Participants
- 222 children
- Comparison
- Once-weekly somatrogon (continued) vs switch from once-daily somatropin to somatrogon
Methodological detailsmain study randomized 1:1
- Main study randomized 1:1
Primary result
As reported in the abstract
Height velocity · OLE Y1 and Y2
- Mean (SD) height velocity (HV) at OLE Y1
- 8.11 (1.84) cm/year
- Mean (SD) HV at OLE Y2
- 7.91 (1.84) cm/year
- Mean (SD) height SD score (SDS) at OLE Y1
- −1.42 (0.90)
- Mean (SD) height SDS at OLE Y2
- −0.95 (0.84)
- Mean ΔHSDS at OLE Y1
- 1.36
- Mean ΔHSDS at OLE Y2
- 1.61
Further findings
- Switched patients had similar HV, height SDS and ΔHSDS to continuous somatrogon
Safety
Adverse events (all causality) · OLE Y1 and Y2
- Incidence of AEs, OLE Y1
- 71.7%
- Incidence of AEs, OLE Y2
- 72.3%
- IGF-I SDS >2 at two consecutive assessments (dose-reduction criteria)
- up to one quarter of patients
- Most AEs mild or moderate
- Most common treatment-related AEs: injection site pain and erythema
Original publication
Extension of the Phase 3 Trial of Somatrogon in Children with Growth Hormone Deficiency: 3 Years of Safety and Efficacy. Horm Res Paediatr. Published 1 June 2026. doi:10.
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