Open-label 9-year follow-up extension phase 2 study of once-weekly somatrogon in children with growth hormone deficiency
Authors' conclusion
Once-weekly somatrogon is a well-tolerated and a viable long-term treatment for GHD in children. More real-world data are needed.
Study context
- Population
- Children with growth hormone deficiency (GHD) who completed a 12-month open-label phase 2 study; 67.9% male, mean age 6.0±2.1 years; 14 centres in Hungary, Bulgaria, Belarus, Ukraine, Russia, Greece and the USentered open-label extension (OLE)
- Participants
- 48 children
- Outcome
- Long-term safety and efficacy
Methodological detailssingle-group, multicentre, up to 9 years
- Single-group
- Multicentre
- Up to 9 years
Main finding
As reported in the abstract
- TEAE incidence at OLE Y1
- 52.1%
- TEAE incidence by Y9
- 23.8%
- Mean annualized height velocity (HV)
- > 5 cm/year
- Height SDS at baseline
- −4.0
- Height SDS by Y8
- −0.2
Further findings
Bone maturation
- No changes in ratio of bone age/chronological age
Growth by ADA presence
- No difference in growth based on ADA presence
Safety
Treatment-emergent AEs (TEAEs)
- TEAE incidence at OLE Y1
- 52.1%
- TEAE incidence by Y9
- 23.8%
- Serious adverse events (AEs) rare, only isolated cases
Antidrug antibodies
- ADA positivity observed; no neutralizing antibodies
- No correlation between ADA presence and TEAE incidence or severity
Original publication
Open-label 9-year follow-up extension phase 2 study of once-weekly somatrogon in children with growth hormone deficiency. J Clin Endocrinol Metab. Published 29 June 2026. doi:10.
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