SAN FRANCISCO — A recent study presented at the ENDO 2025 conference highlighted the efficacy of somapacitan-beco, a once-weekly growth hormone therapy, in improving growth-related outcomes for adolescents with various forms of short stature. The findings signal important advancements in pediatric endocrinology, indicating that somapacitan-beco could revolutionize the treatment landscape for these patients.
Somapacitan-beco, developed by Novo Nordisk, is characterized as a long-acting growth hormone that has already received FDA approval for treating growth hormone (GH) deficiency in both pediatric and adult populations. Dr. Aristides Maniatis, a leading endocrinologist and the study’s principal investigator, emphasized that this investigation focused on adolescents experiencing short stature linked to conditions beyond GH deficiency, including idiopathic short stature, Turner syndrome, Noonan syndrome, and those born small for gestational age.
The study involved a cohort of adolescents aged 10 and older (11 for boys) and examined their growth progress over a period of 26 weeks, in which they received subcutaneous injections of somapacitan-beco at a dose of 0.24 mg/kg once per week. The trial, named REAL9, included 47 participants who had not previously undergone daily GH therapy—an important consideration for evaluating the therapy’s impact on naïve patients.
Growth-related endpoints—such as height velocity and standard deviation scores—demonstrated significant improvement in all participating adolescents, with those not previously treated showing particularly marked enhancements. Additionally, participants who had received daily GH therapy prior exhibited stability in their height velocity, suggesting somapacitan-beco’s effectiveness in maintaining growth rates.
Feedback regarding the safety profile of this new treatment was largely positive. The incidence of adverse effects was comparable to that observed in traditional daily GH therapies, with mild to moderate occurrences noted. For instance, adverse events were reported in 58.3% of the small for gestational age group, and participants with Turner syndrome recorded the highest rate at 81.8%. Importantly, no serious adverse events necessitating dosage adjustments or severe complications were reported, reinforcing the therapy’s potential viability.
Dr. Maniatis underscored the significance of this once-weekly regimen, remarking on its implications for reducing treatment burdens and improving patient adherence compared to daily injections. However, it is crucial to note that somapacitan-beco must receive separate FDA approvals for each of the identified conditions—a factor that could influence its availability on the market.
As the field of endocrinology continues to evolve, the release of somapacitan-beco could represent a significant leap forward for therapeutic approaches addressing growth disorders in adolescents. With continued research and potential regulatory approvals, this therapy may soon offer a new horizon for managing short stature conditions effectively.
For further inquiries, Dr. Aristides Maniatis can be reached at amaniatis@rmpedendo.com.
