Pediatric endocrinology

Once-Weekly Lonapegsomatropin Was Efficacious and Well Tolerated in Chinese Children with Growth Hormone Deficiency: Results from a Phase 3 Randomized Trial

Horm Res PaediatrPublished Randomised controlled trial

Primary result · AHVResult — go to the resultDifference 0.91 cm/year 95% CI 0.37–1.45

Authors' conclusion

Weekly lonapegsomatropin demonstrated non-inferiority and superiority in efficacy compared to daily somatropin among treatment-naive Chinese children with GHD. The treatment groups showed comparable safety and tolerability profiles.

Study context

Population
Treatment-naive, prepubertal Chinese children with growth hormone deficiency (GHD), 17 sites across Chinareceived treatment
Participants
153 participants
Comparison
Weekly lonapegsomatropin vs daily somatropin
Primary endpoint
Annualized height velocity (AHV)
Follow-up
Week 52
Methodological detailsopen-label, active-controlled, phase 3, multicentre (17 sites across China), randomized 2:1
  • Open-label
  • Active-controlled
  • Phase 3
  • Multicentre (17 sites across China)
  • Randomized 2:1

Primary result

AHV

Difference

0.91 cm/year

95% CI 0.37–1.45

P = 0.0010

By group

Lonapegsomatropinvs Somatropin
difference 0.91 cm/year (95% CI 0.37–1.45); P = 0.0010

As reported in the abstract

Secondary outcomes

Least squares (LS) mean

OutcomeLonapegsomatropinSomatropinP value
Change in height SDS from baseline (ΔHT SDS) · week 52Favouring lonapegsomatropin from week 13 onward1.01 (SE 0.04)0.83 (SE 0.05)P < 0.05

Safety

Safety profile similar between treatment groups

Original publication

Once-Weekly Lonapegsomatropin Was Efficacious and Well Tolerated in Chinese Children with Growth Hormone Deficiency: Results from a Phase 3 Randomized Trial. Horm Res Paediatr. Published 27 February 2026. doi:10.1159/000550980

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