Novo’s new trial results stoke blockbuster hopes, with oral semaglutide scoring again in Phase IIIa

Novo Nordisk is building a blockbuster case for its diabetes drug semaglutide, trotting out Phase IIIa trial results Monday that show its new pill version of the drug worked better than placebo at reducing weight and blood sugar in patients. Should the oral version reach the market, Novo would gain an edge in the Type 2 diabetes market to compete with Eli Lilly’s rival drug Jardiance.

Semaglutide, first approved as an injectable by the FDA late last year under the brand name Ozempic, falls in the blockbuster class of drugs known as GLP-1s. This latest trial, called Pioneer-5, put an oral version of the drug up against a placebo in 324 people with Type 2 diabetes and moderate renal impairment. The study primarily looked at how Novo’s pill influenced levels of glycated haemoglobin (HbA1c), an important measure for drugmakers hoping to lower the risk of heart failure and other complications associated with high blood sugar over time.

The trial nailed its primary endpoint, with semaglutide demonstrating a statistically significant and superior improvement in HbA1c compared to placebo. The drug also achieved statistically significant reductions in body weight, the company said in a release.

Mads Krogsgaard Thomsen

“The results from Pioneer-5 showed that oral semaglutide is efficacious and has a solid safety profile in people with type 2 diabetes and moderate renal impairment, thereby further expanding the solid clinical profile of oral semaglutide,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Renal impairment is a serious diabetes complication and people with this condition have limited oral anti-diabetic treatment options, and if approved oral semaglutide represents an efficacious new solution for these people.”

The new data come just a few months after semaglutide nailed a head-to-head comparison to Boehringer Ingelheim and Eli Lilly’s Jardiance, an oral SGLT2-inhibitor approved back in late 2016.

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