Novo Nordisk’s Sogroya Demonstrates Favorable Outcomes in Phase III Trial for Children’s Growth Disorders

Novo Nordisk has shared positive trial results from the Phase III REAL8 basket study of once-weekly growth hormone Sogroya (somapacitan) in pre-pubertal children born small for gestational age (SGA), or with Noonan syndrome (NS), or with idiopathic short stature (ISS). The trial showed that Sogroya was non-inferior to the once-daily growth hormone Norditropin (somatropin) in improving yearly growth rate, as measured by height velocity, at 52 weeks. This positive outcome was presented at the first Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and European Society of Endocrinology (ESE) in Copenhagen, Denmark.¹

Additionally, data from REAL8 showed that Sogroya was well-tolerated, with no new safety or tolerability issues discovered compared to once-daily growth hormone. Patients treated with once-weekly Sogroya experienced a similar insulin-like growth factor 1 response to those treated with the daily growth hormone.

There is also a Turner syndrome (TS) sub-study of REAL8, from which Novo is expecting data later this year.

In a press release, Professor Agnès Linglart, professor of pediatrics at the Bicêtre Paris-Saclay University and Hospital, France, and one of the lead investigators on REAL8, said: “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 wellbeing and quality of life, as well as long-term effects such as increased risk of cardiovascular disease or type 2 diabetes. 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.”

REAL8 met its primary endpoints for the first three sub-studies, demonstrating once-weekly Sogroya as non-inferior to once-daily growth hormone treatment at week 52 across SGA, NS, and ISS.

The study is a randomized, open-label, active-controlled, parallel-group, trial. Following the primary treatment period of 52 weeks, there is a two-year safety extension phase. As mentioned earlier, REAL8 has a basket design which enables once-weekly Sogroya to be evaluated across the four different, but related indications of SGA, NS, ISS, and TS, under one protocol.

“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 seven-year treatment window, this results in one year of missed treatment and can have a significant knock-on impact on their health. We are committed to providing a portfolio of growth hormone therapies with flexibility in administration timing and missed doses, which may better suit the needs of children with growth failure. These encouraging results from REAL8 mark a significant step forward in achieving that commitment,” said Martin Lange, executive vice president for development at Novo Nordisk, in the press release.

Once-weekly Sogroya was approved by the FDA for the treatment of children living with growth hormone deficiency in April 2023. The approval was backed by results from the Phase III REAL4 study, which showed that Sogroya was comparable to daily somatropin for the primary endpoint of annualized height velocity.²

In a press release from time, Stephanie Seremetis, MD, CMO and CVP, rare disease, Novo Nordisk, said, “A once-weekly growth hormone treatment like Sogroya may offer a therapeutic alternative for patients and their caregivers interested in a once-weekly option.”

References

1. Novo Nordisk A/S: Once-weekly 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. Novo Nordisk. News release. May 12, 2025. Accessed May 13, 2025. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916003

2. FDA approves once-weekly Sogroya® for the treatment of children living with growth hormone deficiency. Novo Nordisk. News release. April 28, 2023. Accessed May 13, 2025. https://www.novonordisk-us.com/media/news-archive/news-details.html?id=166098