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• [mHealth] Choose Specialty Spotlight - [Conference Coverage] | [Peer Exchange] | [DE&I] | [Editorial Videos] | [CNS Drug Development Resources] Advertisement News|Articles|December 23, 2025

FDA Approves Oral Wegovy Following Positive Phase III OASIS 4 Trial Results

Author(s)[Andy Studna, Senior Editor] Listen 0:00/0:00

Key Takeaways

• Wegovy pill, the first oral GLP-1 for weight loss, is FDA-approved for reducing cardiovascular risks in adults.
• Phase III OASIS 4 trial showed 16.6% mean weight loss with oral semaglutide, outperforming placebo.
• Significant improvements in glycemic control and cardiovascular risk factors were observed in the OASIS 4 trial.
• Novo Nordisk plans a full US launch of the Wegovy pill in January 2026, with manufacturing in North Carolina.SHOW MORE The FDA approval of oral semaglutide marks the first GLP-1 pill for chronic weight management, supported by Phase III OASIS 4 data demonstrating substantial weight loss, favorable safety, and improvements in cardiometabolic risk factors. Advertisement

## Topline findings: OASIS 4 trial

• Oral semaglutide 25 mg achieved 16.6% mean weight loss at 64 weeks with full adherence, compared with 2.7% for placebo.
• One-third of adherent participants achieved at least 20% weight loss, versus under 3% with placebo.
• Weight loss remained robust in the treatment-policy analysis, at 13.6% versus 2.2% with placebo.
• Serious adverse events occurred less frequently with oral semaglutide than placebo (3.9% vs 8.8%).
• Post hoc analyses showed improvements in glycemic control, blood pressure, and cardiovascular risk factors, including normalization of blood glucose in more than 70% of participants with prediabetes at baseline. The FDA has approved Novo Nordisk’s Wegovy pill (semaglutide), marking the first oral GLP-1 available for weight loss in adults. Additionally, the therapy is indicated to reduce the risk of major adverse cardiovascular events including death, heart attack, or stroke.1 This regulatory action is backed by positive results from the Phase III OASIS 4 clinical trial (NCT05564117). In a company statement, Dave Moore, executive vice president, US operations at Novo Nordisk, said: "The launch of Wegovy in 2021 changed how obesity was viewed and treated in the US. Now, with Wegovy pill, we are offering a magnitude of weight loss that no other oral GLP-1 obesity candidate has been able to duplicate in Phase III trials. We are confident that the expansion of Wegovy to a pill will help patients who may have not sought or accepted treatment before. Wegovy pill is the next chapter in our decades-long GLP-1 experience—supported by the most affordable self-pay price to date in a GLP-1 for obesity. We are prepared for a full US launch in early January 2026, with manufacturing well underway in our North Carolina facilities."

Approval based on topline findings from OASIS 4

Earlier in September,The New England Journal of Medicinepublished topline findings from OASIS 4.2

• With full treatment adherence, oral semaglutide 25 mg produced 16.6% mean weight loss at 64 weeks, versus 2.7% with placebo.
• 34.4% of adherent participants achieved ≥20% weight loss, compared with 2.9% on placebo.
• In the treatment-policy analysis (regardless of adherence), oral semaglutide still achieved 13.6% mean weight loss versus 2.2% with placebo.
• Nearly 30% of participants reached ≥20% weight loss in the treatment-policy analysis, compared with 3.3% on placebo.
• Serious adverse events were less frequent with oral semaglutide (3.9%) than placebo (8.8%), consistent with extensive real-world safety experience. In a press release from the time of publication, Sean Wharton, lead study author and medical director of the Wharton Medical Clinic, said: “Oral semaglutide 25 mg builds on the proven efficacy and established safety and tolerability profile of semaglutide and represents a significant advancement in obesity treatment. People with overweight or obesity have individual preferences, and with oral semaglutide as a potential new treatment option, more of those who are not on treatment today may consider starting GLP-1 treatment.”

Latest OASIS 4 data revealed gains in glycemic control and cardiovascular risk factors

The latest[findings] from OASIS 4 were shared in November, highlighting improvements across glycemic control, cardiovascular risk factors, and weight outcomes.3 Results from a cardiometabolic post hoc analysis examining adult patients’ blood sugar and cardiovascular risk factors showed:

• At week 64, 71.1% of participants with prediabetes at baseline achieved normal blood glucose in the semaglutide group versus 33.3% with placebo.
• Within the semaglutide group, individuals achieving ≥15% weight loss experienced larger reductions in systolic (-10.1 mmHg vs -4.1 mmHg) and diastolic (-4.3 mmHg vs -1.1 mmHg) blood pressure. A pooled post hoc analysis of OASIS 4 and STEP trials found:
• Significant weight loss across all menopause stages: pre-menopausal (18.2%), peri-menopausal (15.0%), and post-menopausal (15.7%).## OASIS 4 trial design OASIS 4 was a 64-week, randomized, double-blind, placebo-controlled trial evaluating once-daily oral semaglutide 25 mg.
• The study enrolled 307 adults with obesity or overweight plus at least one weight-related comorbidity, excluding individuals with diabetes.
• Participants were randomized 2:1 to oral semaglutide or placebo.
• Treatment included a 12-week dose-escalation phase followed by continued therapy through week 64.
• All participants received concurrent lifestyle intervention during the treatment period.
• A 7-week off-treatment follow-up was conducted after treatment completion. As mentioned by Moore, Novo is expecting to launch the Wegovy pill in early January 2026. The pharma company also submitted the oral formulation for approval by the EMA and other regulatory bodies during the second half of this year.

References

1. FDA approves Novo Nordisk's Wegovy® pill, the first and only oral GLP-1 for weight loss in adults. News release. Novo Nordisk. December 22, 2025. Accessed December 23, 2025.[https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-wegovy-pill-the-first-and-only-oral-glp-1-for-weight-loss-in-adults-302648344.html]
2. Novo Nordisk’s oral semaglutide 25 mg (Wegovy® in a pill*) delivered 16.6% weight loss in people with obesity in a newly published study. News release. Novo Nordisk. September 17, 2025. Accessed December 23, 2025.[https://www.globenewswire.com/news-release/2025/09/17/3152045/0/en/Novo-Nordisk-s-oral-semaglutide-25-mg-Wegovy-in-a-pill-delivered-16-6-weight-loss-in-people-with-obesity-in-a-newly-published-study.html]
3. Novo Nordisk’s Phase III OASIS 4 Analyses Highlight Cardiometabolic Benefits of Oral Semaglutide 25 mg.Applied Clinical Trials. November 6, 2025. Accessed December 23, 2025.[https://www.appliedclinicaltrialsonline.com/view/novo-nordisk-oasis-analyses-highlight-cardiometabolic-benefits-oral-semaglutide]

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