Once-weekly GHD treatment shows potential in phase 3 trial
Once-weekly somapacitan (Sogroya; Novo Nordisk) injection in children with growth hormone deficiency (GHD) appears to be non-inferior to somatropin daily injection, according to data presented at the Endocrine Society’s Annual Meeting 2022.
In the phase 3 REAL 4 study, 200 children with GH treatment naïve GHD were randomly assigned in a 2:1 ratio to receive weekly subcutaneous 0.16 mg/kg/week somapacitan (n = 132) or daily subcutaneous 0.034 mg/kg/day somatropin (n = 68) for 52-weeks followed by a 3-year extension period.
There was an annualized height velocity of 11.2 cm/year in the somapacitan group compared to 11.7 cm/year in the somatropin group, meeting the study’s primary endpoint of non-inferiority.
The most common adverse events included headache, nasopharyngitis, pyrexia, pain in extremity, bronchitis, and vomiting.
“The existing treatment options available for children with growth hormone deficiency require daily injections for many years,” said Dr Bradley Miller, MD, PhD, Division of Pediatric Endocrinology, University of Minnesota Masonic Children’s Hospital in a press release. “Based on the results of the REAL 4 study, there is potential for a once-weekly option for children with growth hormone deficiency.”
Read the full press release here.