Novo Nordisk fights back with oral GLP-1 data in obesity

Shortly after reporting weaker-than-expected sales of its injectable GLP-1 drugs, Novo Nordisk revealed clinical results with an oral alternative that suggest it can offer comparable efficacy with convenient, daily dosing.

The new data from the OASIS 4 trial of Novo Nordisk's 25 mg oral formulation of semaglutide included an indirect comparison between the drug and the STEP 1 trial of the current once-weekly injectable form of the GLP-1 agonist, branded as Wegovy.

While comparisons between two different studies can sometimes be misleading, Novo Nordisk said the two drugs showed remarkable similarities across key measures, including the share of patients achieving body weight reductions of 5% to 20%, positive changes in cardiometabolic markers, and quality-of-life scores.

Other results from OASIS 4, reported at the ObesityWeek conference in Atlanta, Georgia, explored the relationship between weight loss with oral semaglutide and measures like blood sugar control and cardiovascular risk factors such as C-reactive protein (CRP) and serum triglyceride levels.

Among the new findings presented were that a higher percentage of participants with pre-diabetes at baseline achieved normal blood glucose at week 64 in the semaglutide group versus placebo - 71.1% versus 33.3% - while those achieving 15% weight reductions or more, saw clinically meaningful benefits in CRP and triglycerides as well as reduced blood pressure.

Patients who reported poor physical function at the start of the trial also saw significant improvements, with a "meaningful change" in ability reported by 77.3% of the oral semaglutide group and 42.9% of those on placebo.

While they come from post-hoc analyses of an existing trial, the results build a picture of efficacy for oral semaglutide as Novo Nordisk prepares to compete in what is expected to be the next big frontier in obesity therapy – the shift from injectable to daily oral therapies.

Eli Lilly's Zepbound/Mounjaro (tirzepatide) is the big challenger to Wegovy in the injectable category at the moment, and a similar two-horse race is being set up in the oral space as Lilly prepares to file its oral GLP-1 agonist orforglipron for approval before the end of the year.

Novo Nordisk filed in the US for what it is calling 'Wegovy in a pill' in February, with a decision by the FDA expected around the end of the year. That could give it a valuable lead over Lilly in the oral GLP-1 category, although the latter company seems to have the momentum in injectables at the moment.

In its third-quarter results update this week, Novo Nordisk also revealed it has now filed for approval of oral semaglutide in the EU for launch in "selected markets," and sees the drug as "a big step forward in terms of expanding the market and for those individuals that align better with taking a pill for their obesity."

Both companies have been investing heavily in direct-to-consumer (DTC) sales channels for cash purchasing of their current injectable products, and Novo Nordisk said on the call it will make oral semaglutide available across all its sales channels if approved.