“Novo Nordisk A/S: Oral Semaglutide 50 Mg Achieved 15.1% Weight Loss in OASIS 1 Trial”, 2023-05-22 ():
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: Novo Nordisk today announced headline results from OASIS 1, a phase 3a trial in the global OASIS programme. OASIS 1 is a 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. Both treatment arms were in conjunction with lifestyle intervention. The trial achieved its primary endpoint by demonstrating a statistically-significant and superior weight loss at week 68 with oral semaglutide 50 mg versus placebo.
When evaluating the effects of treatment if all people adhered to treatment1 from a mean baseline body weight of 105.4 kg, people treated with oral semaglutide 50 mg 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 50 mg, reached a weight loss of 5% or more after 68 weeks, compared to 24.5% with placebo.
When applying the treatment policy estimand2, people treated with oral semaglutide 50 mg achieved a superior weight loss of 15.1% compared to 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 2.4 mg in obesity branded as Wegovy®”, said Martin Holst Lange…In the trial, oral semaglutide 50 mg 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.
Novo Nordisk expects to file for regulatory approval in the US and the EU in 2023.
…About the OASIS clinical trial programme: OASIS is a phase 3 clinical development programme with once-daily oral semaglutide 25 mg and 50 mg in obesity. The global clinical phase 3 programme currently consists of 4 trials, having enrolled ~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 50 mg 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 50 mg 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 50 mg 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 25 mg versus placebo in 300 adults with obesity or overweight with one or more comorbidities.