Danish pharmaceutical company Novo Nordisk has reported positive results from the OASIS 1 Phase IIIa clinical trial of oral semaglutide 50mg.
The company said the trial had met its primary endpoint of superior weight loss at week 68 in adults with obesity or overweight.
OASIS 1 is a part of the OASIS clinical trial programme, which also includes OASIS 2, OASIS 3 and OASIS 4.
These trials have collectively enrolled more than 1,300 adult subjects with obesity or overweight with one or more comorbidities.
OASIS 1 compared the safety and efficacy of 50mg of semaglutide administered orally once a day against a placebo in 667 adults for 68 weeks.
Novo Nordisk said a superior weight loss of 15.1% had been observed in patients treated with semaglutide against a reduction of 2.4% in patients who were given the placebo.
In addition, 84.9% of the semaglutide arm achieved a weight loss of 5% or more compared with 25.8% of those given the placebo.
A weight loss of 5% or more was also seen in 89.2% of the patients who received 50mg of oral semaglutide after 68 weeks, compared with 24.5% who were given placebo.
The oral semaglutide was found to be safe and well-tolerated in the trial with mild to moderate adverse events, which diminished over time and were consistent with the GLP-1 receptor agonist class.
Novo Nordisk Development executive vice-president Martin Holst Lange said: “The results show comparable weight loss as in the STEP I trial with injectable semaglutide 2.4mg in obesity branded as Wegovy.
“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.”
Novo Nordisk plans to file for regulatory approval of semaglutide 50mg in the EU and US later this year.