- Danish drugmaker Novo Nordisk on Monday said a pill version of its popular obesity drug succeeded in a Phase 3 trial, delivering a comparable weight loss effect to what’s been observed in testing of its injectable counterparts.
- In the study, overweight or obese patients lost an average of 15.1% of their body weight after taking the pill for 68 weeks, versus a 2.4% loss for placebo recipients. The results were similar to those for a weekly injectable version of the drug, semaglutide, that Novo sells as Wegovy.
- Novo expects to file for approval in the U.S. and Europe this year. But it cautioned that the launch of the drug will depend on manufacturing capacity, which has been a struggle for Novo amid surging demand for Wegovy. A pill would be more convenient for patients.
The study results come two years after Novo won approval of Wegovy and five years after the clearance of Ozempic, a diabetes medicine also based on semaglutide and widely used off-label for weight loss.
The findings could spur even more interest in the medicines, which have become so coveted that Novo has had a hard time making enough doses.
Novo has repeatedly revised its production plans and sales outlook for Wegovy in the first year of its launch. But manufacturing issues have persisted, and last month Novo said it would add a second contract manufacturer to help. The Danish company has even paused an advertising campaign for Wegovy to slow the surging demand for the drug.
Amid Novo’s struggles, Eli Lilly is closing in with a rival medicine called Mounjaro. The drug, already approved for diabetes, succeeded in two studies in obesity and could be approved as a weight loss treatment by the end of the year. Like Novo, Lilly is retooling its manufacturing to meet demand. Earlier this year, the company said it would add a new factory in North Carolina to increase supply of Mounjaro and Trulicity, another diabetes drug.
All of those medicines are injectable, however. Novo is leading an emerging race, involving Pfizer and biotech Viking Therapeutics, to develop pills that are just as effective. Data from an early study of one of Pfizer’s prospects were published in a medical journal on Monday, sending the drugmaker’s shares up more than 4%.
The Phase 3 study Novo reported on, meanwhile, is one of four the company is running on oral semaglutide. Known as OASIS-1, it involved 667 adults who were either obese or overweight and had at least one comorbidity. Novo said around 89% of those who took the pill lost at least 5% of their weight, whereas about 25% of those on placebo hit that threshold.
The most common side effects reported were gastrointestinal, deemed mild to moderate in degree and diminished over time, the company said.