Once-weekly somapacitan enhances linear growth in girls with Turner syndrome: a randomized controlled phase 3 study
Primary result · HVResult — go to the resultETD −0.8 cm/year 95% CI −1.57 to −0.11Authors' conclusion
Once-weekly somapacitan showed non-inferiority and is comparable to daily GH after 52 weeks of treatment in enhancing linear growth while maintaining IGF-I concentrations within a similar range in treatment-naïve girls with TS. Similar safety profiles and tolerability were observed for both groups.
Study context
- Population
- Treatment-naïve, prepubertal girls with Turner syndrome (TS) aged 2.5–10 years; 49 clinics in 18 countriesrandomized 2:1
- Participants
- 105 participants
- Comparison
- Once-weekly somapacitan vs daily GH
- Primary endpoint
- Height velocity (HV; cm/year)
- Follow-up
- Week 52
Methodological detailsopen-labelled, active-comparator, phase 3, basket study, non-inferiority, multicentre
- Open-labelled
- Active-comparator
- Phase 3
- Basket study
- Non-inferiority
- Multicentre
Primary result
HV
ETD
−0.8 cm/year
95% CI −1.57 to −0.11
By group
Somapacitanvs Daily GH
ETD −0.8 cm/year (95% CI −1.57 to −0.11)
As reported in the abstract
Further findings
| Outcome | Somapacitan | Daily GH |
|---|---|---|
| IGF-I SDS · week 52 | mean +1.71 (SD 1.38) | mean + 1.95 (SD 1.11) |
IGF-I SD score (SDS) · week 52
- IGF-I SDS increased in both groups
Safety
- Discontinued trial product due to AEs
- 0
- Safety profiles were similar between groups
Original publication
Once-weekly somapacitan enhances linear growth in girls with Turner syndrome: a randomized controlled phase 3 study. J Clin Endocrinol Metab. Published 1 August 2026. doi:10. 1210/ clinem/ dgag309
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