Headline results from OASIS 1 - a phase 3a 68-week, efficacy and safety trial comparing once-daily oral semaglutide 50 mg for weight management to placebo in 667 adults with obesity or overweight with one or more comorbidities – have revealed the trial achieved its primary endpoint by demonstrating a statistically significant and superior weight loss at week 68 with oral semaglutide 50mg versus placebo.
When evaluating the effects of treatment if all people adhered to treatment from a mean baseline body weight of 105.4kg, people treated with oral semaglutide 50mg achieved a statistically significant weight loss of 17.4% after 68 weeks compared to a 1.8% reduction with placebo. In addition, 89.2% of those who received oral semaglutide 50mg, reached a weight loss of 5% or more after 68 weeks, compared to 24.5% with placebo.
When applying the treatment policy estimand, people treated with oral semaglutide 50mg achieved a superior weight loss of 15.1% vs a reduction of 2.4% with placebo and 84.9% achieved a weight loss of 5% or more, compared to 25.8% with placebo.
“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 with injectable semaglutide 2.4mg in obesity branded as Wegovy”, said Martin Holst Lange, executive vice president for Development at Novo Nordisk. “The choice between a daily tablet or weekly injection for obesity has the potential to offer patients and healthcare providers the opportunity to choose what best suits individual treatment preferences”.
In the trial, oral semaglutide 50mg appeared to have a safe and well-tolerated profile. The most common adverse events were gastrointestinal, and the vast majority were mild to moderate and diminished over time and were consistent with the GLP-1 receptor agonist class. Gastrointestinal adverse events were most prominent during dose escalation.
OASIS is a phase 3 clinical development programme with once-daily oral semaglutide 25mg and 50mg in obesity. The global clinical phase 3 programme currently consists of four trials, having enrolled approximately 1,300 adults with obesity or overweight with one or more comorbidities.
OASIS 1 – a 68-week efficacy and safety phase 3a trial of once-daily oral semaglutide 50mg versus placebo in 667 adults with obesity or overweight with one or more comorbidities.
OASIS 2 – a 68-week efficacy and safety phase 3a trial of once-daily oral semaglutide 50mg versus placebo in 198 East Asian (including Japan) adults with obesity or overweight with one or more comorbidities.
OASIS 3 – a 44-week efficacy and safety phase 3a trial of once-daily oral semaglutide 50mg versus placebo in 200 Chinese adults with obesity or overweight with one or more comorbidities.
OASIS 4 – a 64-week efficacy and safety phase 3b trial of once-daily oral semaglutide 25mg versus placebo in 300 adults with obesity or overweight with one or more comorbidities.
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