The New England Journal of Medicine published the results from the OASIS 4 phase 3 trial that studied the efficacy and safety of the investigational once-daily oral semaglutide 25 mg (Wegovy® in a pill*), marking a significant milestone in the company’s ambition to advance obesity care.
In the 64-week trial, oral semaglutide 25 mg, alongside lifestyle modifications, was compared to placebo in 307 adults with obesity or overweight with one or more weight-related comorbidities, without diabetes.
“The oral semaglutide 25 mg data show compelling efficacy for an oral weight management medication with 16.6 percent weight loss and a safety and tolerability profile consistent with injectable Wegovy,” said Martin Holst Lange, chief scientific officer and executive vice president of Research & Development at Novo Nordisk.
“Currently, less than 2 percent of individuals with obesity in the US receive obesity medication and Wegovy in a pill may also address patient preference for oral treatment,” he added.
Results showed that if all participants adhered to treatment, average weight loss of 16.6 percent was achieved by people taking oral semaglutide 25 mg compared to 2.7 percent for placebo at 64 weeks, with over a third (34.4 percent) experiencing a weight loss of 20 percent or more, versus 2.9 percent for placebo.
This was comparable with previous trial results of injectable Wegovy.
When looking at the effect regardless of whether the participants took the medicine exactly as they should, people taking oral semaglutide 25 mg still achieved an average weight loss of 13.6 percent versus 2.2 percent with the placebo. Close to a third (29.7 percent) had a weight loss of 20 percent or more versus 3.3 percent for placebo.
Additionally, the study also found that oral semaglutide 25 mg improved cardiovascular risk factors, as well as the ability to be more active in daily life, compared to placebo. This was consistent with previous trial results of injectable Wegovy.
In February, Novo Nordisk submitted a New Drug Application (NDA) for the once-daily pill formulation of Wegovy. The Food and Drug Administration (FDA) review of this NDA is anticipated to be completed by the end of this year. Currently, there are no approved oral formulations of a GLP-1 medicine for weight loss.
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