According to a story from Globe Newswire, the global healthcare company Novo Nordisk recently announced encouraging findings from its phase 3 clinical trial. This study was evaluating somapacitan (marketed as Sogroya) in an injection formulation as a treatment to help pediatric patients with growth hormone deficiency achieve annualized height velocity (AHV) growth targets. The study was conducted in prepubescent children with the disorder.
About Growth Hormone Deficiency
Growth hormone deficiency is a medical condition in which the body’s pituitary gland does not release sufficient levels of growth hormone. It is characterized primarily by abnormally short height. Causes of the condition are varied; it may be the result of a genetic abnormality (the genes GH1, BTK, or GHRHR are typically involved), treatment with radiation therapy, injuries, tumors, or infections. However, the cause is unclear in about a third of cases. Symptoms in children include developmental delays, jaundice, small penis size, low hair growth, and low blood sugar. Symptoms in adults include poor bone density, high cholesterol, reduced muscle mass, baldness (in men), heart problems, increased body fat, and issues with fatigue and concentration. Treatment is typically with supplementation of growth hormone via injection, however this treatment can cause unpleasant side effects. To learn more about growth hormone deficiency, click here.
About The Trial
This trial involved a total of 200 pediatric patients with growth hormone deficiency that had not received treatment with growth hormone supplementation. Somapacitan was compared along side somatropin (marketed as Norditropin) and was able to produce a similar result: 11.2 cm AHV for somapacitan versus 11.7 AHV for somatropin. However, somapacitan was only administered once a week; somatropin is administered daily.
With these findings, the therapy was able to achieve its primary endpoint of non-inferiority, as the difference in AHV between the two treatments was not considered significant. Somapacitan could represent an advancement in the quality of life patients, since they will only need to receive an injection on a weekly basis instead of a daily one.
About Somapacitan
Somapacitan is a human growth hormone analogue that is approved around much of the world for the treatment of growth hormone deficiency in adults. With these encouraging results, it could start to gain approval for use in pediatric patients as well.
