By Jacob Gronholt-Pedersen
COPENHAGEN (Reuters) -Wegovy-maker Novo Nordisk presented new data on Wednesday showing its experimental weight-loss pill improved blood sugar control and reduced cardiovascular risk factors, bolstering the Danish drugmaker’s case for the treatment ahead of an expected U.S. approval by year-end.
If that goes ahead, the pill would be the first oral GLP-1 treatment approved for weight management.
New analyses from the OASIS 4 clinical trial, presented at ObesityWeek 2025 in Atlanta, showed oral semaglutide 25 mg delivered cardiovascular benefits and weight loss comparable to the company’s blockbuster injectable Wegovy.
NOVO WAITING FOR US APPROVAL OF PILL BY YEAR-END
The U.S. Food and Drug Administration (FDA) accepted Novo’s application for oral Wegovy in May and is expected to decide by the end of the fourth quarter. Novo has said it expects approval and plans to launch soon after.
Novo trimmed its full-year profit and sales forecasts on Wednesday as sales growth stalled, but investors cheered a better-than-expected Medicare pricing deal.
Novo is going through a tumultuous period marked by a share price plunge and slowing sales growth, which have prompted a change of CEO and a board shake-up.
In the analysis, 71.1% of participants with prediabetes who took the pill achieved normal blood glucose at 64 weeks, compared with 33.3% on placebo. Patients who lost at least 15% of their body weight saw greater improvements in blood pressure and reductions in inflammatory markers and triglycerides.
An indirect comparison between the OASIS 4 trial and the earlier STEP 1 trial of injectable Wegovy showed that the oral and injectable formulations delivered comparable results on weight loss targets and cardiometabolic markers.
Novo has said it plans to make the pill available through telehealth platforms including Ro and WeightWatchers, once approved. The company is also considering a subscription model with discounted pricing.
Hims & Hers Health said last week it was in talks with Novo to offer both injectable and oral Wegovy through its platform.
The pill showed 16.6% weight loss in the primary OASIS 4 results published in September in the New England Journal of Medicine.
(Reporting by Jacob Gronholt-Pedersen; Editing by Alexandra Hudson)
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