Individuals who were treated with 50 mg oral semaglutide (Novo Nordisk) achieved a statistically significant weight loss of approximately 17.4% after 68 weeks compared to a 1.8% reduction with the placebo, according to headline results from the OASIS 1 phase 3a trial.
The analysis demonstrated these findings when evaluating the effects of the treatment if all individuals adhered to treatment and had a mean baseline body weight of 105.4 kg.
“We are very pleased with the weight loss demonstrated by the once daily oral formulation of semaglutide in obesity. The results show comparable weight loss as in the STEP 1 trial [(NCT03548935)] with injectable semaglutide 2.4 mg in obesity branded as Wegovy,” Martin Holst Lange, executive vice president for Development at Novo Nordisk, said in a company press release. “The choice between a daily tablet or weekly injection for obesity has the potential to offer patients and health care providers the opportunity to choose what best suits individual treatment preferences.”
The OASIS 1 study (NCT05035095) is a 68-week efficacy and safety trial comparing once daily oral semaglutide for weight management to a placebo in 667 individuals with obesity or overweight with 1 or more comorbidities. Both treatment arms also included lifestyle interventions.
The trial achieved its primary endpoint of a statistically significant and superior weight loss at week 68 with the drug compared to the placebo. Additionally, investigators found that approximately 89.2% of those who received oral semaglutide in the 50 mg strength achieved a weight loss of 5% or more after 68 weeks compared to 24.5% with the placebo.
When investigators applied the treatment policy estimand, individuals administered semaglutide achieved superior weight loss of 15.1% compared to a reduction of 2.4% with the placebo and 84.9% achieved a weight loss of 5% or more compared to the placebo at 25.8%.
Oral semaglutide also had a safe and well-tolerated profile, with the most common adverse effects (AEs) being gastrointestinal. Most AEs were mild to moderate, diminished over time, and were consistent with other drugs within the glucagon-like peptide-1 receptor agonist class. In dose escalation, gastrointestinal AEs were most prominent.
Novo Nordisk expects to file for regulatory approval in both the United States and the European Union in 2023. OASIS 1 is part of a global clinical phase 3 program that consists of 4 trials enrolling approximately 1300 individuals with obesity or overweight with 1 or more comorbidities.
OASIS 2 (NCT05132088) will be a 68-week efficacy and safety trial of oral semaglutide compared to a placebo in 198 individuals who are East Asian with obesity or overweight and 1 or more comorbidities. OASIS 3 will be a 44-week efficacy and safety trial of semaglutide compared to a placebo in 200 individuals who are Chinese with obesity or overweight with 1 or more comorbidities.
Lastly, OASIS 4 (NCT05564117) will be a 64-week efficacy and safety trial of oral semaglutide in the 25 mg strength in 300 individuals with obesity or overweight with 1 or more comorbidities.
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. News release. Novo Nordisk. May 22, 2023. Accessed May 25, 2023. https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=166110