Pediatric endocrinology

Once-weekly somapacitan enhances linear growth in girls with Turner syndrome: a randomized controlled phase 3 study

J Clin Endocrinol MetabPublished Randomised controlled trial

Primary result · HVResult — go to the resultETD −0.8 cm/year 95% CI −1.57 to −0.11

Authors' 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

OutcomeSomapacitanDaily GH
IGF-I SDS · week 52mean +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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