Effective growth hormone replacement with once‐weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial
Authors' conclusion
Somapacitan showed sustained efficacy in Japanese children with GHD over 104 weeks and for 52 weeks after switching from daily GH. Somapacitan was well tolerated and preferred over daily GH.
Study context
- Population
- Treatment-naïve Japanese children with GH deficiency (GHD)randomised 2:1
- Participants
- 30 children
- Comparison
- Once-weekly somapacitan vs daily growth hormone (GH)
- Primary endpoint
- HV (cm/year)
- Follow-up
- Weeks 52 and 104
Methodological detailsopen-labelled, parallel-group, phase 3
- Open-labelled
- Parallel-group
- Phase 3
Primary result
As reported in the abstract
Observed mean HV · up to Week 52
Further findings
HV · Week 104
- Height velocity (HV): Daily GH group received 1-year somapacitan after switch
HV · Week 104
- Similar HVs between groups at Week 104 (soma/soma vs switch)
Other height-related endpoints
- Supported continuous growth
IGF-I SD score (SDS)
- Increased in both groups; mean IGF-I SDS within −2 and +2 during the study
Preference for once-weekly somapacitan over daily GH among patients/caregivers who switched at Week 52
- Preferred once-weekly somapacitan
- 90.9%
Safety
Tolerability and injection site reactions
- Mild injection site reaction
- one
- Somapacitan was well tolerated
- No reports of injection site pain
Original publication
Effective growth hormone replacement with once‐weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial. Clin Endocrinol (Oxf). Published 18 February 2024. doi:10.
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