Novo Nordisk announced topline results of the landmark OASIS-1 study this Monday on May 22, 2023. OASIS is Phase 3a drug development program with oral Semaglutide 25 mg and 50 mg once a day in adults with overweight and obesity.  The global OASIS program includes 4 different studies in obese and overweight persons with one or more comorbidities.

OASIS 1 is a 68-week efficacy and safety study of once daily semaglutide 50 mg versus placebo in 667 adults with obesity or overweight with one or more comorbidities. The duration of the study was 68 weeks. Subjects in both treatment arms received guidance on lifestyle modification throughout the duration of study.

Results showed that the trial achieved the primary endpoint by demonstrating statistically significant superior weight loss at week 68 with oral semaglutide 50 mg versus placebo. Oral semaglutide 50 mg once a day achieved weight loss of 17.4% versus a 1.8% reduction with placebo after 68 weeks. More than 5% weight loss was observed in about 89% subjects who were treated with oral semaglutide versus 24.5% treated with placebo. These topline results were demonstrated in people who adhered to treatment.

Meanwhile, in all people treated with oral semaglutide, regardless of adherence, weight loss was 15.1% versus 2.4% for placebo.

The weight loss results are comparable with injectable semaglutide. These results will offer a choice to patients and healthcare professionals to choose between oral and injectable treatments.

Assessment of safety and tolerability showed that oral semaglutide 50 mg once a day appeared to be safe and well tolerated in the trial. The most common adverse events were gastrointestinal; the majority were mild to moderate in nature and diminished over time, while they were consistent with the GLP-1 receptor agonist class.

The full study results are yet to be published.

Reference

1. Novo Nordisk A/S: Oral Semaglutide 50 mg achieved 15.1% weight loss (17.4% if all people adhered to treatment) in adults with obesity or overweight in the OASIS 1 trial. Available at: https://www.novonordisk.com/news-and-media/news-and-ir-materials/news-details.html?id=166110, May 22, 2023. Accessed on May 25, 2023.