Oral semaglutide has demonstrated phase 3 efficacy in adolescents with type 2 diabetes, highlighting its potential as a more accessible treatment option for this population.
What the trial showed
The findings come from the PIONEER TEENS trial, where the therapy delivered a 0.83% reduction in HbA1c versus placebo at 26 weeks in patients aged 10–17 years, with a safety profile consistent with earlier semaglutide studies.
The 52-week, placebo-controlled trial included 132 patients receiving standard background treatment with metformin, insulin, or both, supporting its potential as an add-on option in real-world care.
Why it matters
Commenting on the results, Martin Holst Lange, Executive Vice President of R&D, Novo Nordisk, said: “These results confirm that 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.”
The need for new treatment options is increasing. The prevalence of type 2 diabetes in younger populations has risen substantially over the past two decades, while available therapies remain limited.
Data from the US Centers for Disease Control and Prevention suggest cases among young people could rise nearly eightfold by 2060, compared with relatively stable rates of type 1 diabetes.
Wider landscape
The phase 3 readout comes amid growing competition in the incretin space. Eli Lilly has recently launched its oral GLP-1 therapy, orforglipron, in the US for weight loss in adults, although it has not yet been approved for type 2 diabetes or studied in adolescents.
So far, the company has only reported phase 3 results from the SURPASS-PEDS trial of its injectable therapy tirzepatide in this population, demonstrating HbA1c reductions of around 2.2% alongside meaningful decreases in BMI.
While this represents a greater reduction in glycaemic markers than that observed with oral semaglutide, differences in administration route is likely a contributing factor.
Novo Nordisk plans to seek regulatory approval for oral semaglutide for adolescents in the US and EU later this year.
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