- Oral semaglutide 25 mg improves blood sugar control and cardiovascular risk factors.
- Comparable efficacy observed between oral and injectable semaglutide formulations.
- Weight loss efficacy consistent across menopausal stages in women.
- FDA review of oral semaglutide expected by year-end 2025.
Overview of OASIS 4 Trial
Novo Nordisk presented findings from the OASIS 4 phase 3 trial at ObesityWeek 2025, focusing on oral semaglutide 25 mg. The trial demonstrated improvements in blood sugar control and cardiovascular risk factors in adults with overweight and obesity.
Comparative Efficacy
An indirect comparison between oral semaglutide 25 mg and its injectable counterpart showed similar efficacy in achieving significant weight loss and improving cardiometabolic markers.
Weight Loss Across Demographics
Analyses revealed consistent weight loss efficacy in women with obesity, regardless of menopausal stage. Pre-menopausal, peri-menopausal, and post-menopausal women all experienced significant weight reductions over 64 weeks.
Physical Function Improvements
Participants with low physical function at baseline reported improvements after 64 weeks of treatment with oral semaglutide 25 mg, as measured by the Patient Global Impressions of Status questionnaire.
Safety and Tolerability
The safety profile of oral semaglutide 25 mg was consistent with the injectable form, with mild to moderate gastrointestinal side effects being the most common. The incidence of serious adverse events was lower in the semaglutide group compared to placebo.
Regulatory Status
Novo Nordisk has submitted a New Drug Application for the oral formulation, with FDA review expected to conclude by the end of 2025. If approved, production will occur in North Carolina.
