Novo Nordisk, the maker of Wegovy, unveiled new data on Wednesday showing that its experimental oral weight-loss drug significantly improved blood sugar control and reduced cardiovascular risk factors. The results strengthen the Danish company’s case for approval of what could become the first oral GLP-1 therapy for weight management, expected by the end of this year.
Fresh analyses from the OASIS 4 clinical trial, presented at ObesityWeek 2025 in Atlanta, revealed that oral semaglutide 25 mg achieved weight loss and cardiovascular benefits comparable to the injectable Wegovy. In the study, 71.1% of participants with prediabetes taking the oral drug reached normal blood glucose levels at 64 weeks, compared to 33.3% in the placebo group. Patients who lost more than 15% of their body weight also showed notable reductions in blood pressure, inflammatory markers, and triglycerides.
The FDA accepted Novo’s application for oral Wegovy in May, with a decision expected by the end of the fourth quarter. Novo anticipates a rapid launch following approval.
Despite recently trimming its annual profit and sales outlook amid slowing growth and leadership changes, investor sentiment improved following a favorable Medicare pricing agreement.
An indirect comparison of OASIS 4 and STEP 1 (the pivotal trial for injectable Wegovy) showed both forms delivering comparable outcomes in terms of weight loss and cardiometabolic health.
Once approved, Novo plans to make the oral drug accessible via telehealth providers such as Ro and WeightWatchers, and is reportedly exploring a subscription-based pricing model. Telehealth platform Hims & Hers Health has also confirmed ongoing discussions with Novo to offer both versions of Wegovy.
The OASIS 4 primary results, published in The New England Journal of Medicine in September, demonstrated an average 16.6% reduction in body weight, underscoring the pill’s potential as a convenient alternative to injectable therapies.
Also Read