The phase 3 REAL8 trial shows once-weekly Sogroya effectively improves growth in children with growth disorders, offering a promising alternative to daily injections.
Results from the phase 3 REAL8 clinical trial (NCT05330325) demonstrate that once-weekly somapacitan (Sogroya; Novo Nordisk) was noninferior to the once-daily growth hormone somatropin (Norditropin; Novo Nordisk) in improving yearly growth rate in prepubertal children born small for gestational age (SGA), with Noonan syndrome (NS), or with idiopathic short stature (ISS). These data were presented as 3 late-breaking abstracts at the first Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and European Society of Endocrinology (ESE) in Copenhagen, Denmark.1,2
Trial Name: A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow (REAL 8)
ClinicalTrials.gov ID: NCT05330325
Sponsor: Novo Nordisk A/S
Completion Date (Estimated): October 29, 2027
Sogroya is a prescription human growth hormone analogue similar to current daily growth hormone. It is approved for the once-weekly treatment of children and adults who do not produce enough growth hormone. The treatment uses albumin-binding prolongation technology to attach to albumin—a protein in the blood—to help delay its removal from the body. The treatment has been used for over 20 years in manufacturer’s diabetes treatment.1
“Children with growth failure face many health challenges beyond just being shorter than their peers. They often have metabolic disruptions and developmental difficulties that can seriously affect their well-being and quality of life, as well as long-term effects such as increased risk of cardiovascular disease or type 2 diabetes,” said REAL8 lead investigator Agnès Linglart, professor of pediatrics at the Bicêtre Paris-Saclay University and Hospital in France, in the news release. “The REAL8 data presented today marks an important step forward in providing these patients with an effective, once-weekly option that can potentially reduce treatment burden and improve adherence and treatment outcomes.”1
REAL8 is a randomized, open-label, active-controlled, parallel-group, phase 3 trial that is part of the ongoing REAL clinical trial program. It evaluated the efficacy and safety of once-weekly Sogroya in children born with SGA, or with TS, NS, or ISS. It consisted of a primary treatment period of 52 weeks followed by a 2-year safety extension phase.1,2
Prepubertal patients were randomly assigned to receive either once-weekly Sogroya (0.24 mg/kg/week) or Norditropin (0.050 mg/kg/day). The clinical trial information states that children with SGA were randomly assigned to receive either 0.24 mg/kg of Sogroya once per week, or low-dose (0.035 mg/kg) or high-dose (0.067 mg/kg) Norditropin once per day.1,2
The REAL8 data demonstrated that Sogroya was well-tolerated, with no safety or tolerability issues identified compared to once-daily growth hormone Norditropin. Additionally, insulin-like growth factor 1 response in patients who were treated with once-weekly Sogroya was similar to those treated with daily Norditropin.
Of note, the REAL8 trial had achieved its primary end points for the first 3 substudies. In these substudies, Sogroya demonstrated the following: superior estimated mean height velocity (HV) when compared with a lower dose (0.035 mg/kg/day) of Norditropin (11.0 vs 9.4 cm/year) and noninferior estimated mean HV when compared with a higher dose (0.067 mg/kg/day) of Norditropin (11.0 vs 11.1 cm/year) in children with SGA; superior estimated mean HV compared with somatropin (10.4 vs 9.2 cm/year) in children with NS; noninferior estimated mean HV compared with daily Norditropin (10.5 vs 10.5 cm/year) children with ISS.1,2
Nonadherence to growth hormone treatment is a common problem, hindering successful treatment outcomes for patients. In pediatric patients, daily injections can be a burden for them and their caregivers, leading to lack of adherence because of discomfort or pain at injection sites, inconvenience, and disruption to daily life. Previously, it was observed that missing daily injections resulted in a difference of up to 6.1 cm in height over 3 years in nonadherent patients compared with adherent patients.1
“Treatment adherence is an issue when it comes to improving outcomes in children with growth failure. Imagine if a child misses only one day of treatment each week, amounting to 52 missed days per year. Over a 7-year treatment window, this results in 1 year of missed treatment and can have a significant knock-on impact on their health,” said Martin Lange, executive vice president for Development at Novo Nordisk. “These encouraging results from REAL8 mark a significant step forward.”1
