Setting the stage for a battle with rival Eli Lilly (NYSE:LLY), Novo Nordisk (NYSE:NVO) reported data this week from a late-stage trial of its oral formulation of semaglutide, a medication for people with Type II diabetes.
The GLP-1 agonist is traditionally administered via injection. Both insulin-makers have approved versions of the injectable semaglutide, but Novo Nordisk is the first to take its oral formulation into large clinical studies.
The 26-week Pioneer I trial evaluated the efficacy and safety of a 3-, 7- and 14-mg dose of oral semaglutide compared to a placebo in 703 people with Type II diabetes.
The Phase III study met its primary endpoint, showing significant improvements in long-term blood sugar for patients taking any of the three doses of oral semaglutide. Novo Nordisk also noted that participants taking the 14-mg dose of semaglutide showed significant weight loss compared to people taking the placebo.
Importantly, the drug was well-tolerated, with 5-16% of people given semaglutide reporting nausea versus 6% of the group treated with a placebo.
“We are very encouraged by the results of the Pioneer 1 trial, which confirm the unprecedented oral efficacy of semaglutide that was reported in the Phase II clinical trial in Type II diabetes,” Mads Krogsgaard Thomsen, Novo Nordisk’s EVP & chief science officer, said in prepared remarks.
The company is slated to report data from its other nine Pioneer trials sometime this year and expects to seek regulatory approval for the oral drug in 2019.
