Novo Nordisk announces results from phase 3 PIONEER PLUS trial

pharmafile | March 28, 2023 | News story | Research and Development  

Novo Nordisk has announced headline results from the phase 3b PIONEER PLUS trial for the safety and efficacy of once-daily oral semaglutide 25mg and 50mg versus 14mg as an add-on to a stable dose of 1-3 oral antidiabetic medicines in patients with type 2 diabetes.

The trial’s primary endpoint was met, meaning the drug demonstrated a statistically significant and superior reduction in HbA1c at week 52 with both the 25mg and 50mg doses when compared to the 14mg dose.

With a mean baseline body weight of 96.4kg, patients treated with the 25mg and 50mg doses experienced a statistically higher weight lost of 7.0kg and 9.2kg compared with a loss of 4.5kg from the oral semaglutide 14mg dose.

The drug appeared to have a safe and well-tolerated profile, with the most common adverse effects being gastrointestinal, the majority of which were mild to moderate and diminished over time, as well as being consistent with the GLP-1 receptor agonist class. These gastrointestinal adverse events were most prominent during dose escalation and were more frequent with the 25mg and 50mg doses of oral semaglutide than the 14mg dose.

Martin Holst Lange, executive vice president for Development at Novo Nordisk, commented: “We are pleased to see the results from the PIONEER PLUS trial which add further evidence of the benefits of oral semagutide for people living with type 2 diabetes. The higher efficacy from 25mg and 50mg doses provides the option to progress to higher doses if additional glycemic control or weight loss are needed.”


Betsy Goodfellow

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