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Hormone Research in Paediatrics
Article . 2025 . Peer-reviewed
License: CC BY NC
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Somapacitan is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: a Randomised Controlled Phase 3 Study

Authors: Junfen Fu; Xinran Cheng; Michael Højby; Chunxiu Gong; Tina Lund Leunbach; Yanhong Li; Haiyan Wei; +3 Authors

Somapacitan is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: a Randomised Controlled Phase 3 Study

Abstract

Introduction: REAL6 is a randomized, multi-centre, open-labelled, active-controlled parallel group phase 3 trial (NCT04970654) investigating once-weekly somapacitan, a reversible albumin-binding growth hormone (GH) derivative, in Chinese children with GH deficiency (GHD). Methods: 110 treatment-naïve patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (Norditropin®; 0.034 mg/kg/day) for 52 weeks. Annualized height velocity (HV; cm/year) at week 52 was the primary measurement. Additional assessments included HV standard deviation score (SDS), height SDS, bone age, insulin-like growth factor-I (IGF¬ I) SDS, and observer-reported outcomes. Results: Estimated mean HV at week 52 was 11.0 and 10.4 cm/year for somapacitan and daily GH, respectively. Non-inferiority of somapacitan compared to daily GH was confirmed. Changes in HVSDS, height SDS, bone age, and IGF-I SDS from baseline to week 52 were similar between groups. At week 52, mean (SD) IGF-I SDS was within intended reference range (-2.0 to +2.0) and comparable between groups: +0.5 (1.4) for somapacitan versus +0.1 (1.2) for daily GH. Somapacitan was well-tolerated with a safety profile consistent with the well-known safety profile of daily GH. A low proportion of injection-site reactions were reported for somapacitan (2.7%), with no reports of injection-site pain during the 52-week treatment period. Disease burden was reduced from baseline to week 52 for both treatments. Somapacitan reduced treatment burden compared to daily GH. Conclusions: Efficacy and safety profiles were comparable for Chinese children with GHD treated with somapacitan or daily GH. Both treatments similarly reduced disease burden, while treatment burden was reduced with somapacitan.

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
9
Top 10%
Average
Top 10%
Green
hybrid