Following positive topline results from its phase 3a trial, Novo Nordisk is seeking approval for its oral GLP-1 RA therapy for pediatric patients aged 10 to 17 years with type 2 diabetes.
In the PIONEER TEENS trial, oral semaglutide led to a statistically-significant reduction in HbA1C (a measure of blood sugar) at 26 weeks of 0.83% compared to a placebo. It was also well tolerated with a safety profile consistent with other semaglutide trials that Novo has conducted.
Currently, the first-line treatment for youth-onset type 2 diabetes is metformin and insulin. However, there are issues with both: metformin fails in glycemic control in around half of adolescent patients and insulin may lead to hypoglycemia and weight gain. An oral GLP-1 RA, therefore, could resolve an unmet need.
Should oral semaglutide receive approval, it will become the first GLP-1 RA that provides superior glycemic efficacy compared to a placebo in pediatric patients with type 2 diabetes. Oral semaglutide is already available in the U.S. and EU for adult T2 diabetes patients as Rybelsus. In addition, Novo expects to request an approval for a label expansion of its Ozempic pill in the second half of 2026.