Somapacitan Is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: A Randomized 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 (HSDS), 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.

SUBMITTER: Fu J 

PROVIDER: S-EPMC12129415 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature