Once-Weekly Lonapegsomatropin Was Efficacious and Well Tolerated in Chinese Children with Growth Hormone Deficiency: Results from a Phase 3 Randomized Trial
Primary result · AHVResult — go to the resultDifference 0.91 cm/year 95% CI 0.37–1.45Authors' 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
| Outcome | Lonapegsomatropin | Somatropin | P value |
|---|---|---|---|
| Change in height SDS from baseline (ΔHT SDS) · week 52Favouring lonapegsomatropin from week 13 onward | 1.01 (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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