Novo Nordisk’s Sogroya® proves effective for childhood growth disorders in Phase 3 study

DENMARK— Novo Nordisk has announced encouraging results from its phase 3 REAL8 basket study, revealing that once-weekly Sogroya® (somapacitan) is as effective as the once-daily growth hormone Norditropin® (somatropin) in promoting growth in children with various growth disorders.

The trial focused on pre-pubertal children born small for gestational age (SGA), those with Noonan syndrome (NS), and children with idiopathic short stature (ISS).

After 52 weeks of treatment, Sogroya® demonstrated non-inferior yearly growth rates compared to daily Norditropin®, measured by height velocity (HV).

Notably, in children with Noonan syndrome, Sogroya® showed superior growth outcomes, with an estimated mean HV of 10.4 cm/year versus 9.2 cm/year for daily somatropin.

 Similarly, in children born SGA, once-weekly Sogroya® outperformed a lower dose of daily growth hormone (11.0 cm/year vs. 9.4 cm/year) and matched the efficacy of a higher dose (11.0 cm/year vs. 11.1 cm/year).

For children with ISS, growth rates were comparable between the two treatments (10.5 cm/year each)’

The study also confirmed that Sogroya® was well-tolerated, with no significant safety or tolerability issues compared to daily injections.

The insulin-like growth factor 1 (IGF-1) response, an important marker of growth hormone activity, was similar between patients receiving once-weekly Sogroya® and those on daily treatment.

These findings were presented at the first Joint Congress of the European Society for Paediatric Endocrinology (ESPE) and the European Society of Endocrinology (ESE) in Copenhagen, Denmark, highlighting the potential of Sogroya® to reduce the treatment burden for children with growth disorders

Growth hormone therapy typically requires daily injections, which can be challenging for children and their caregivers.

 The discomfort, inconvenience, and disruption to daily life often lead to poor adherence, compromising treatment success.

 One study cited showed that missing daily injections could result in a height difference of 6.1 cm over three years between adherent and non-adherent patients.

Martin Lange, Novo Nordisk’s Executive Vice President for Development, emphasized the importance of treatment adherence, noting that missing even one day per week adds up to 52 missed treatment days annually.

Over a typical seven-year treatment period, this equates to a full year without treatment, potentially impacting the child’s long-term health.

He stressed Novo Nordisk’s commitment to offering flexible growth hormone therapies that better fit patients’ needs, with Sogroya® representing a significant advancement in this effort.

The REAL8 trial met its primary endpoints across the three studied conditions, marking a major step in providing effective, less burdensome treatment options for children facing growth challenges

Results from the Turner syndrome (TS) sub-study of REAL8 are expected later this year, which could further expand the potential applications of Sogroya®.

In April 2025, based on the positive data from REAL8 and the ongoing REAL9 trial, Novo Nordisk submitted regulatory applications in the European Union for Sogroya® to treat children with SGA, NS, and ISS, moving closer to making this once-weekly treatment widely available.

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