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Novo Nordisk's Oral Semaglutide Succeeds In First Phase III, But Prompts Questions

 
• By Emily Hayes

In PIONEER 1, weight loss results for the oral version of the GLP-1 agonist were somewhat disappointing and lack of detail in the top-line release prompts concerns about compliance.

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Novo Nordisk AS's positive top-line data for its oral semaglutide in the Phase III PIONEER 1 study in type 2 diabetes – the first of 10 studies to report – are reassuring in some ways, but raise questions about whether weight loss and compliance are good enough to carry the tablet version of the GLP-1 agonist.

The rest of the trials in the PIONEER development program, which involves more than 9,000 patients, are set to read out this year, putting the company in a position to file for regulatory approval in the first quarter of 2019. A weekly subcutaneous formulation of semaglutide was approved by the US FDA in December and is marketed as Ozempic

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