Novo Nordisk (NVO) said Wednesday that oral semaglutide 25 mg (Wegovy in a pill) delivered 16.6% weight loss in people with obesity in a phase 3 trial.
In the 64-week OASIS 4 study of 307 adults without diabetes, participants taking the pill alongside lifestyle changes lost an average of 16.6% of body weight, compared with 2.7% for placebo. Over a third (34.4%) achieved at least 20% weight loss, versus 2.9% for placebo.
Novo said the results were comparable with previous trial results of injectable Wegovy. The safety and tolerability profile of oral semaglutide was also consistent with that for injectable Wegovy.
Oral semaglutide 25 mg also demonstrated improvements in the ability to perform everyday physical activities such as bending, standing, walking, being physically active, and improvements in cardiovascular risk factors.
In February, Novo Nordisk filed a New Drug Application (NDA) for a once-daily pill version of Wegovy®. The FDA is expected to complete its review by year-end. At present, no oral GLP-1 treatments for weight loss have been approved.
If approved by the FDA, the pill for weight management will be fully made in the U.S., with production already underway at Novo Nordisk’s significantly expanded manufacturing facility.
The results come as Eli Lilly on Wednesday reported that its oral GLP-1 drug, orforglipron, outperformed oral semaglutide in a phase 3 head-to-head trial in adults with type 2 diabetes, delivering greater improvements in blood sugar control and weight loss over 52 weeks.
The data suggested that participants on the highest dose of orforglipron lost an average of 19.7 pounds (9.2%), compared to 11.0 pounds (5.3%) for those on oral semaglutide. This represents a notable improvement of 73.6% in weight loss for orforglipron.