Novo Nordisk, (makers of Wegovy and Ozempic), has released results from a trial of its oral semaglutide treatment for type 2 diabetes. The trial involved 1-3 oral antidiabetic medicines and a stable dose, and found that the 25 mg and 50 mg doses of oral semaglutide resulted in a statistically significant reduction in HbA1c, a measure of blood sugar control, compared to the 14 mg dose. People treated with the 25 mg and 50 mg doses also lost more weight than those treated with the 14 mg dose. The trial showed that all doses of oral semaglutide had a safe and well-tolerated profile, with gastrointestinal adverse events being the most common. This is a huge jump in dosage, and tracks along with studies they are also working on with nearly 3x strength of injectable semaglutide!
Martin Holst Lange, Executive Vice President for Development at Novo Nordisk, said that the results showed the benefits of oral semaglutide for people living with type 2 diabetes. The company expects to file for regulatory approvals in the US and EU in 2023, although the global rollout of the higher doses will depend on portfolio priorities and manufacturing capacity.
Novo Nordisk's PIONEER clinical development program for oral semaglutide includes nine global clinical trials involving over 10,000 adults with type 2 diabetes. Oral semaglutide 3 mg, 7 mg and 14 mg are already approved under the brand name Rybelsus for type 2 diabetes. The company's mission is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. Novo Nordisk employs around 54,400 people in 80 countries and markets its products in around 170 countries.
