Novo Nordisk announces phase III clinical data of Sogroya, showing new progress in long-acting growth hormone treatment for children with growth disorders

On 20255month12 , Novo Nordisk released its plan for pre-pubertal growth. Topline data from a Phase 3 clinical trial of once-weekly long-acting growth hormone Sogroya (Somapacitan) in children with disorders. The trial results show that Sogroya has a significant effect in improving the annual growth rate of children with growth disorders. Its efficacy is equivalent to the existing daily injection of growth hormone Noze (Norditropin, somatropin), and it is well tolerated. This important development brings a more convenient and effective treatment option for children with growth hormone deficiency, especially reducing the burden of daily injections for patients and families.

Sogroyais a long-acting human growth hormone analog that was initially approved in the United States in August 2020. It is used to replace insufficient endogenous growth hormone in adult patients with growth hormone deficiency. Subsequently, in 2023year4month, Sogroya was approved for the treatment of growth disorders caused by insufficient secretion of endogenous growth hormone in children 2.5 years old and above. This innovative drug greatly improves the convenience of medication by dosing it once a week, avoiding the cumbersomeness of traditional daily injections.

The data released this time come from the three-phase randomized open-label parallel controlREAL8 trial (registration numberNCT05330325), which focused on evaluating SogroyaEfficacy and safety of n>with Nozine in children aged 2 to 10 years old with small for gestational age (SGA), Turner syndrome, Noonan syndrome, and idiopathic short stature. In the trial, children with Noonan syndrome, Turner syndrome and idiopathic short stature were treated with 0.24 mg/kg Sogroya weekly, while the other group received daily injections of 0.050 mg/kg.of Noze. Children who were small for gestational age were divided into three groups, receiving 0.24 mg/kg Sogroya per week. , daily0.035mg/kglow-dose Noze or daily0.067mg/kghigh-dose Noze.

Research results show that Sogroya performs as well as Noze in terms of height growth rate at 52. Specifically, among children who were small for gestational age, the annual growth rate of Sogroya was 11.0 cm, which was significantly better than the 9.4 cm in the low-dose control group and the same as the 11.1 cm in the high-dose control group. When children with Noonan syndrome received Sogroya treatment, their annual growth rate was 10.4cm, which was significantly higher than the 9.2cm in the control group. Among children with idiopathic short stature, the annual growth rate of Sogroya and the control drug were both 10.5cm, showing comparable efficacy. In terms of safety, Sogroya was well tolerated, with no serious safety issues reported, and there was no significant difference in response to insulin-like growth factor 1 (IGF-1) compared with the control drug.

Novo Nordisk said detailed data on patients with Turner syndrome from the REAL8 trial will be released later in 2025. It is worth noting that in April this year, the company has launched REAL8 and single-arm REAL9 span>(NCT05723835) trial data, submission of marketing applications to EU and US regulatory agencies including indications in children with small for gestational age, Noonan syndrome and Turner syndrome. These clinical studies cover children who are small for gestational age and related diseases aged 10 years and above, demonstrating the broad potential of Sogroya in the field of various childhood growth disorders. The release of this clinical data lays a solid foundation for the drug's regulatory approval and clinical application, and also brings new hope for treatment to patients and their families.

Reference materials:Sogroya® (somapacitan) is an efficacious and well-tolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE. Retrieved May 12, 2025.