Key Highlights
- Oral semaglutide from Novo Nordisk achieved its primary endpoint in a phase 3 study evaluating children and teens with type 2 diabetes
- Participants experienced a reduction in HbA1c levels of 0.83 percentage points compared to placebo during the 26-week study period
- Study enrolled 132 participants ranging from 10 to 17 years of age
- This would mark the first oral GLP-1 medication approved for pediatric populations
- Regulatory submissions in the United States and European Union are scheduled for the latter half of 2026
Novo Nordisk announced Thursday that its oral semaglutide medication successfully demonstrated efficacy in reducing blood glucose levels among children and teenagers diagnosed with type 2 diabetes, based on findings from a phase 3 clinical study.
The clinical study enrolled 132 participants aged 10 through 17 and ran for a duration of 26 weeks. Those receiving the oral medication experienced a decrease in hemoglobin A1c levels that was 0.83 percentage points greater than participants who received placebo treatment.
Novo Nordisk characterized these findings as statistically meaningful, confirming that the study achieved its primary objective.
This marks a groundbreaking development as the first clinical trial evaluating an oral GLP-1 medication in pediatric populations. At present, no oral GLP-1 treatment has received approval for children or adolescents.
The medication is currently marketed as Rybelsus and Ozempic pill for adults. The oral formulation of Ozempic is anticipated to launch in the United States during the second quarter of 2026.
Historically associated with adults, type 2 diabetes now affects a significant number of young people. According to CDC statistics, approximately 364,000 individuals under age 20 in the United States currently have diagnosed diabetes.
Shortage of Effective Treatments for Younger Patients
Physicians managing type 2 diabetes in pediatric populations face limited therapeutic options. Metformin represents the primary first-line treatment, yet it proves inadequate in controlling blood glucose in approximately 50% of adolescent cases.
Insulin therapy remains another key option, though it presents challenges including hypoglycemia risk and potential weight increase. An oral medication with favorable tolerability would address a significant unmet medical need.
Martin Holst Lange, serving as Novo Nordisk’s chief scientific officer, noted that type 2 diabetes prevalence among young populations has increased dramatically during the past 20 years.
“Oral semaglutide is an effective treatment option for children and adolescents with Type 2 diabetes who require glycaemic control beyond that provided by the current standard of care,” Lange said.
Company Plans Late 2026 Regulatory Submissions
The Danish pharmaceutical company intends to pursue regulatory approval to expand labeling for both Rybelsus and Ozempic pill to encompass pediatric populations in the United States and European Union during the second half of 2026.
Approval would establish semaglutide as the inaugural oral GLP-1 medication authorized for use in children and adolescents.
Safety data from the trial aligned with observations from previous semaglutide studies conducted in adult subjects.
Gaining approval would allow Novo to expand its semaglutide product portfolio into an untapped patient demographic, potentially providing a competitive advantage over competitor Eli Lilly (LLY) in the diabetes and obesity treatment markets.
Novo Nordisk expects to complete regulatory submissions in both regions prior to year-end.
