Introduction
Somatrogon is a long-acting recombinant human growth hormone being developed as a once weekly treatment for children with growth hormone deficiency (GHD). The objective of this Phase 3 study (NCT03874013) was to compare the efficacy and safety of once-weekly somatrogon with once-daily Genotropin in Japanese children with GHD.
Methods
In this open-label, randomized, active-controlled study, 44 prepubertal Japanese children with GHD (boys: 3 to <11 years; girls: 3 to <10 years) were randomized 1:1 to receive once weekly somatrogon or once daily Genotropin (0.025 mg/kg/day) for 12 months. Dose escalation for somatrogon-treated subjects occurred in the first 6 weeks (0.25, 0.48, and 0.66 mg/kg/week; 2 weeks each) with the remaining 46 weeks at a dose of 0.66 mg/kg/week. The study’s primary endpoint was annualized height velocity (HV) at 12 months.
Results
Baseline characteristics were similar between treatment groups. Compared with Genotropin-treated subjects, somatrogon-treated subjects had higher least-squares (LS) mean HV at 12 months (9.65 cm/year vs 7.87 cm/year). Once weekly somatrogon was concluded as being comparable to once daily Genotropin as the mean treatment difference (somatrogon-Genotropin) in HV was +1.79 cm/year (95% CI, 0.97–2.60), which was greater than the pre-established margin (–1.8 cm/year). For both treatment groups, most adverse events were mild to moderate in severity and a similar proportion of subjects reported injection-site pain, although the somatrogon group reported more painful injections.
Conclusion
In prepubertal Japanese children with GHD, once-weekly somatrogon was comparable to once-daily Genotropin in terms of annualized (12-month) HV. Both treatments had similar safety and tolerability profiles.
ClinicalTrials.gov:NCT03874013