The phase III REAL 4 of Sogroya shows efficacy in growth hormone deficiency.

The phase III REAL 4 (REversible ALbumin) study (NCT03811535) is part of the ongoing REAL clinical study programme and was designed to evaluate the efficacy and safety of somapacitan injection in children with growth disorders, comprising a 52-week main phase followed by a three-year extension period. Two-hundred growth hormone (GH) treatment naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2:1 ratio to receive weekly subcutaneous 0.16 mg/kg/week Sogroya (n=132) or daily subcutaneous 0.034 mg/kg/day somatropin (Norditropin) (n=68).

In the phase III study, REAL 4, Sogroya showed a not significantly different AHV of 11.2 cm/year, compared to 11.7 cm/year for Norditropin. Based on the main phase results of REAL 4, once-weekly Sogroya was shown to work as well as daily Norditropin for children with GHD, meeting its primary endpoint of non-inferiority. The most common AEs observed in at least 5% were events commonly observed in children, including headache, nasopharyngitis, pyrexia, pain in extremity, bronchitis and vomiting. These results from the REAL 4 study, in prepubertal children with growth hormone deficiency (GHD), were presented at the Endocrine Society’s Annual Meeting (ENDO 2022) in Atlanta, Georgia (US).