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aEstimated treatment difference (ETD) [95% CI] = 0.5 [-1.1; 0.2]1
bEstimated treatment difference (ETD) [95% CI] = 0.05 [-0.18; 0.08]1
REAL4 is a multinational, non-inferiority, open labelled, active-controlled parallel group phase 3 trial. A total of 200 treatment-naive prepubertal children with a confirmed diagnosis of growth hormone deficiency were randomised 2:1 to receive once-weekly Sogroya® 0.16 mg/kg/week (n = 132) or once-daily Norditropin® 0.034 mg/kg/day (n = 68). The primary endpoint was annualised height velocity (HV) at week 52.2
REAL4 is a multinational, non-inferiority, open labelled, active-controlled parallel group phase 3 trial. A total of 200 treatment-naive prepubertal children with a confirmed diagnosis of growth hormone deficiency were randomised 2:1 to receive once-weekly Sogroya® 0.16 mg/kg/week (n = 132) or once-daily Norditropin® 0.034 mg/kg/day (n = 68). The primary endpoint was annualised height velocity (HV) at week 52.2
REAL4 is a multinational, non-inferiority, open labelled, active-controlled parallel group phase 3 trial. A total of 200 treatment-naive prepubertal children with a confirmed diagnosis of growth hormone deficiency were randomised 2:1 to receive once-weekly Sogroya® 0.16 mg/kg/week (n = 132) or once-daily Norditropin® 0.034 mg/kg/day (n = 68). The primary endpoint was annualised height velocity (HV) at week 52.2
Sogroya® Summary of Product Characteristics. 2022:1-92.
Miller BS JC Rasmussen MH, et al. Weekly Somapacitan is Effective and Well Tolerated In children With GH Deficiency: The Randomised Phase 3 REAL4 Trial. J Clin Endocrinol Metab. 022:00(0):1-11.