Oral Semaglutide Pill Shows Promising Weight Loss Results in Landmark Trial
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A new once-daily oral formulation of semaglutide, marketed as wegovy in pill form, demonstrated important weight loss in a Phase III clinical trial, offering a potential new option for individuals struggling with obesity and related health conditions. Published on Thursday in The New England Journal of Medicine,the OASIS 4 trial results signal a potential expansion of access to effective weight management therapies.
The 64-week trial, involving 307 adults with obesity or overweight and weight-related comorbidities – but without diabetes – compared the efficacy and safety of oral semaglutide 25 mg alongside lifestyle modifications to a placebo group.Participants taking the oral semaglutide achieved an average weight loss of 16.6 percent, a substantial betterment compared to the 2.7 percent weight loss observed in the placebo group. Notably, over a third of those on the medication experienced weight loss of 20 percent or more, compared to just 2.9 percent in the placebo group.
Significant Weight Loss and Health Benefits
The findings build upon previous successes with injectable semaglutide, commonly known as Wegovy. “The OASIS 4 trial results further underscore the significant impact that semaglutide can have in achieving enduring weight loss and broader health benefits,” stated the lead study author, medical director of the Wharton Medical Clinic, in a news release. The oral formulation, he added, “builds on the proven efficacy and established safety and tolerability profile of semaglutide and represents a significant advancement in obesity treatment.”
The potential for an oral option is particularly important, as individual preferences vary. According to the study author, offering an oral semaglutide option could encourage more individuals with overweight or obesity to consider GLP-1 treatment, a class of medications known for their effectiveness in weight management.
Regulatory Pathway and future availability
Novo Nordisk, the manufacturer of wegovy, submitted a New Drug Application (NDA) for the oral formulation to the Food and Drug Governance (FDA) in February.The company anticipates the FDA’s review will be completed by the end of 2025, possibly paving the way for the pill’s availability to patients.
The OASIS 4 trial results represent a significant step forward in addressing the global obesity epidemic, offering a convenient and effective treatment option for those seeking sustainable weight loss and improved health outcomes.
