Oral semaglutide has shown phase 3 efficacy in adolescents with type 2 diabetes, positioning it as a potential first oral GLP-1 receptor agonist 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, while maintaining a safety profile consistent with earlier semaglutide studies.
Importantly, the study was a 52-week, placebo-controlled trial involving 132 patients, all of whom were receiving standard background treatment with metformin, insulin, or both – highlighting the drug’s 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.”
He added that the need for new options is growing, noting that the prevalence of type 2 diabetes in younger populations has increased substantially over the past two decades, while treatment choices remain limited.
That challenge is expected to only grow over time. Data from the US Centers for Disease Control and Prevention suggest cases of type 2 diabetes 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 at a time of increasing 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.
However, the US drugmaker has 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.
This represents a greater reduction in glycaemic markers than that observed with Novo’s oral semaglutide, although this could be linked to the administration route.
While Lilly’s injectable has shown stronger efficacy, Novo’s oral semaglutide may be viewed as more convenient by younger patients, positioning it as a potentially more accessible option if approved.
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