Core Insights - The OASIS 4 phase 3 trial demonstrated the efficacy and safety of oral semaglutide 25 mg (Wegovy in a pill), showing significant weight loss and potential as a new treatment option for obesity management [1][5][7] Efficacy of Oral Semaglutide - Participants adhering to treatment lost an average of 16.6% of their body weight compared to 2.7% for placebo over 64 weeks, with 34.4% achieving a weight loss of 20% or more [2][3] - Even with varying adherence, participants on oral semaglutide still experienced an average weight loss of 13.6% versus 2.2% for placebo, with 29.7% losing 20% or more [3][7] Safety and Tolerability - The safety profile of oral semaglutide was consistent with injectable Wegovy, with mild to moderate gastrointestinal adverse events, primarily nausea (46.6% vs. 18.6% for placebo) and vomiting (30.9% vs. 5.9% for placebo) [4][5] - Serious adverse events occurred in 3.9% of participants on oral semaglutide compared to 8.8% for placebo, reinforcing its safety profile [4][5] Market Potential and FDA Submission - Novo Nordisk has submitted a New Drug Application (NDA) for oral semaglutide, with FDA review expected to be completed by the end of the year, potentially addressing the less than 2% of individuals with obesity currently receiving medication [5][6] - If approved, the oral formulation will be produced in the US, with manufacturing already underway at Novo Nordisk's expanded facility [6] Broader Health Benefits - Oral semaglutide also showed improvements in cardiovascular risk factors and daily physical activity, indicating broader health benefits beyond weight loss [3][7] Industry Context - The introduction of oral semaglutide represents a significant advancement in obesity treatment, as it is the first oral GLP-1 therapy submitted for chronic weight management in the US [7][14] - The obesity epidemic is a complex disease influenced by various factors, and effective long-term management options are crucial for patient care [11]