- Oral semaglutide 25 mg achieved 16.6% weight loss in a 64-week trial.
- FDA review of the New Drug Application is expected by year-end.
- Production is underway at Novo Nordisk's expanded US facility.
- No approved oral GLP-1 formulations for weight loss currently exist.
Study Results
The OASIS 4 phase 3 trial evaluated the efficacy and safety of oral semaglutide 25 mg in 307 adults with obesity or overweight, excluding those with diabetes. Over 64 weeks, participants achieved an average weight loss of 16.6% compared to 2.7% with placebo. More than a third experienced a weight loss of 20% or more.
Health Improvements
Participants taking oral semaglutide also showed improvements in cardiovascular risk factors and daily physical activities, such as bending, standing, and walking. These results align with previous trials of injectable Wegovy®.
Safety Profile
The safety and tolerability of oral semaglutide were consistent with injectable Wegovy®. Gastrointestinal adverse events were mostly mild to moderate, with nausea and vomiting being the most common. Serious adverse events were lower in the semaglutide group compared to placebo.
Regulatory Status
Novo Nordisk has submitted a New Drug Application for oral semaglutide to the FDA, with a review expected by the end of the year. If approved, it will be the first oral GLP-1 therapy for chronic weight management, with production already underway in the US.
