Novo Nordisk Announces Positive New Analyses from Phase 3 OASIS 4 Trial of Oral Semaglutide 25 mg for Weight Management

Novo Nordisk today announced the latest data from the OASIS 4 Phase 3 clinical trial. Post-hoc analysis showed that the investigational oral semaglutide 25 mg was associated with significant improvements in blood glucose control and cardiovascular (CV) risk factors across various weight loss categories. Additionally, two further analyses also indicated,The drug showed consistent weight loss effects in obese women of different menopausal statuses, while their physical function also improved.

In the post-hoc analysis of cardiovascular metabolic indicators in the OASIS 4 study, researchers evaluated the impact of weight loss magnitude on glycemic parameters and cardiovascular risk factors in overweight and obese adult subjects. The results showed that, compared with placebo, once-daily oral semaglutide 25 mg led to greater improvements in glycemic indicators, including glycated hemoglobin (HbA1c), fasting plasma glucose, and fasting serum insulin, and significantly reduced cardiovascular risk biomarkers such as C-reactive protein and serum triglycerides.

Further analysis showed that in the overall trial population,Among participants with prediabetes at baseline, the proportion reverting to normal blood glucose levels at week 64 was significantly higher in the semaglutide group (71.1%) compared to the placebo group (33.3%).Moreover, participants in the oral semaglutide group were significantly more likely to achieve a weight loss of ≥15%. In the semaglutide group,Compared with those who lost <15% of their body weight, individuals achieving ≥15% weight loss showed significantly greater improvements in systolic blood pressure (-10.1 mmHg vs -4.1 mmHg) and diastolic blood pressure (-4.3 mmHg vs -1.1 mmHg); reductions in inflammatory and lipid markers such as C-reactive protein (0.34 vs 0.74, ratio relative to baseline), non-high-density lipoprotein cholesterol (0.90 vs 0.96), and triglycerides (0.73 vs 0.87) were also more pronounced.Overall, all indicators generally improved in the semaglutide group, with a more significant reduction in body weight.May bring more significant metabolic benefits.

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In addition, the study also released the results of comparative analysis with other trial data:

Comparison Between Different Dosage Forms

Comparison of data from the OASIS 4 (oral semaglutide) and STEP 1 (injectable semaglutide) Phase 3 trials shows that oral and injectable formulations perform similarly in achieving key efficacy endpoints, including different levels of weight loss (≥5%, ≥10%, ≥15%, ≥20%), improving cardiometabolic indicators, and enhancing quality of life scores.

Analysis of Weight Changes Stratified by Menopausal Status

Post-hoc analysis results from the OASIS 4 and STEP trials indicate that semaglutide can lead to significant weight loss regardless of menopausal stage.During the 64-week follow-up, the average weight loss for premenopausal women was 18.2%, for perimenopausal women it was 15%, and for postmenopausal women it was 15.7%; the proportions achieving >15% weight loss were 58.1%, 56.5%, and 53.4%, respectively.This result is comparable to the weight loss performance of Wegovy (semaglutide) injection 2.4 mg in the STEP 1 trial.

Benefits for Patients with Poor Physical Function

In another post-hoc analysis, subjects who self-reported poor physical function (PF) at baseline showed greater improvement at week 64 after treatment with oral semaglutide compared to the overall study population. 77.3% of patients in the semaglutide group achieved clinically meaningful improvement in PF scores, compared to 42.9% in the placebo group.

In terms of safety, the safety and tolerability of oral semaglutide are consistent with injectable Wegovy, and no new safety signals were observed.

References:

[1] Novo Nordisk presents four new analyses on oral semaglutide 25 mg (Wegovy® in a pill*) at ObesityWeek® 2025, including demonstrated reductions in cardiovascular risk factors. Retrieved November 5, 2025 from https://www.prnewswire.com/news-releases/novo-nordisk-presents-four-new-analyses-on-oral-semaglutide-25-mg-wegovy-in-a-pill-at-obesityweek-2025-including-demonstrated-reductions-in-cardiovascular-risk-factors-302605329.html

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