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

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• USA - English

• Post hoc analyses include data showing investigational oral semaglutide 25 mg use was associated with improvements in blood sugar control and cardiovascular (CV) risk factors across multiple categories of weight loss¹
• Another analysis detailed an indirect trial comparison between oral semaglutide 25 mg and the currently available injectable form, showing comparable efficacy²
• In two additional analyses, oral semaglutide 25 mg was associated with the same weight loss efficacy in women with obesity regardless of menopausal stage, and patients reported improvements in physical function, respectively^3,4

PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Nov. 5, 2025 /PRNewswire/ -- Novo Nordisk today presented new data from the OASIS 4 phase 3 trial that explored a variety of patients and hypotheses, adding to the body of evidence supporting this potential treatment option.¹ Four abstracts in total were presented, highlighting a breadth of results with oral semaglutide 25 mg during ObesityWeek^® 2025 in Atlanta, GA.

"Novo Nordisk has pioneered innovation in the obesity class for 25 years, and the oral semaglutide data at ObesityWeek^® reflect our drive to improve the lives of people living with obesity," said Martin Holst Lange, chief scientific officer and executive vice president of Research & Development at Novo Nordisk. "The OASIS 4 results that we are sharing at this important meeting build on existing clinical trial evidence for oral semaglutide and extend findings beyond weight loss to suggested improvements in overall health."

A cardiometabolic post hoc analysis from the OASIS 4 phase 3 clinical trial examined how the amount of weight patients lost affects glycemic parameters (blood sugar control) and cardiovascular (CV) risk factors in adults with overweight and obesity. In participants with overweight or obesity, once-daily oral semaglutide 25 mg treatment compared with placebo led to greater improvements in glycemic parameters, including HbA1c, fasting plasma glucose, and fasting serum insulin, as well as CV risk factors such as C-reactive protein and serum triglycerides.

Results showed that in the overall trial population, a higher percentage of participants with pre-diabetes at baseline achieved normal blood glucose (sugar) at week 64 in the semaglutide group versus placebo (71.1% versus 33.3%). Participants treated with oral semaglutide 25 mg were more likely to achieve ≥15% body weight reduction, compared with those who received placebo. Within the semaglutide group, more people who achieved ≥15% body weight reduction saw larger improvements than those with <15% weight reduction in systolic (−10.1 mmHg versus −4.1 mmHg, mean change from baseline) and diastolic (−4.3 mmHg versus −1.1 mmHg, mean change from baseline) blood pressure readings. Reductions in levels of inflammatory marker C-reactive protein (0.34 versus 0.74, ratio to baseline) and in lipids (blood fats), including non–high density lipoprotein cholesterol (0.90 versus 0.96, ratio to baseline) and triglycerides (0.73 versus 0.87, ratio to baseline), were also observed. While improvements were observed across measures within the semaglutide group, greater improvements were observed in people who had achieved a ≥15% body weight reduction in the trial.¹

"As recently published in The New England Journal of Medicine, the primary results from the OASIS 4 clinical trial demonstrated weight loss efficacy of investigational oral semaglutide 25 mg as a potential therapeutic option for people with obesity and overweight," said Domenica Rubino, MD, trial investigator and Director, Washington Center for Weight Management and Research in Washington, DC. "It's exciting to see these new results from the cardiometabolic post hoc analysis, which showed that while benefits were most pronounced in people who achieved greater than 15% weight loss, clear improvements in glycemic parameters and CV risk factors were observed in patients taking oral semaglutide 25 mg, regardless of how much weight was lost, based on the groups observed."

Additional OASIS 4 data

Indirect comparison between formulations
Data presented from an indirect treatment comparison of the OASIS 4 (oral semaglutide) and STEP 1 (injectable semaglutide) phase 3 clinical trials in adults with obesity and overweight demonstrated that key outcomes — like the share of people reaching ≥5%, ≥10%, ≥15%, ≥20% body weight reductions, positive changes in cardiometabolic markers, and quality of life scores — were comparable for the oral and injectable formulations in these trials, respectively.²

Weight reduction by menopause status
A pooled, post hoc analysis of the OASIS 4 and STEP trials showed that regardless of menopause stage, use of semaglutide was associated with significant weight loss. Pre-menopausal women lost an average of 18.2% body weight, while peri-menopausal women lost 15%, and post-menopausal women lost an average of 15.7% body weight over 64 weeks. The percentage of women in the analysis who achieved more than 15% weight loss included: 58.1% (in the pre-menopausal group), 56.5% (in the peri-menopausal group), and 53.4% (in the post-menopausal group). Results were comparable to the weight loss seen in the STEP 1 trial of Wegovy^® (semaglutide) injection 2.4 mg.³

Patients with obesity and poor physical function
Another post hoc analysis from OASIS 4 showed that people in the semaglutide group who self-reported low physical function (PF) at the start of the trial, as determined by the Patient Global Impressions of Status (PGI−S) questionnaire, saw improvements compared to the overall study population at 64 weeks. A meaningful change in PF score was achieved by most patients (77.3%) taking oral semaglutide 25 mg versus those taking placebo (42.9%).⁴

Exploratory post hoc analyses are hypothesis-generating, and further work investigating the clinical validity of these results would be of value.

The safety and tolerability profile of oral semaglutide 25 mg, as reported in the recently published OASIS 4 study in The New England Journal of Medicine, was consistent with that for injectable Wegovy^®.^5,6 In the OASIS 4 trial, gastrointestinal adverse events with oral semaglutide 25 mg were generally mild to moderate in severity and transient; the most common of which were nausea (46.6% versus 18.6% for placebo) and vomiting (30.9% versus 5.9% for placebo). Adverse events leading to permanent treatment discontinuation were 6.9% (oral semaglutide 25 mg) and 5.9% (placebo). The incidence of serious adverse events was 3.9% (oral semaglutide 25 mg) and 8.8% (placebo).⁵ This reinforces the safety and tolerability profile of semaglutide, as also demonstrated in more than 37 million patient-years of exposure.^5,6

Oral semaglutide 25 mg (Wegovy^® in a pill^*) is not FDA approved. In February, Novo Nordisk submitted a New Drug Application (NDA) for the once-daily pill formulation of Wegovy^®.⁷ The FDA review of this NDA is anticipated to be completed by the end of this year.⁸ Currently, there are no approved oral formulations of a GLP-1 medicine for weight loss.

If approved by the FDA, Wegovy^® in a pill will be fully made in the US, with production already underway at Novo Nordisk's North Carolina manufacturing facilities.

About OASIS 4
OASIS 4 was a 64-week phase 3 randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of once-daily oral semaglutide 25 mg versus placebo in 307 adults with obesity (BMI ≥ 30 kg/m²) or overweight (BMI ≥ 27 kg/m²) with one or more weight-related comorbidities.⁵ People with diabetes were excluded.⁵ OASIS 4 included a 64-week treatment period, including a 12-week dose escalation, and a 7-week off-treatment follow-up period.⁵

In total, 307 participants were randomized in a 2:1 ratio to once-daily oral semaglutide 25 mg or placebo, alongside lifestyle intervention for 64 weeks.⁵

About obesity
Obesity is a serious, chronic, progressive, and complex disease that requires long-term management.^9-11 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.^9,11 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.^12,13

About Wegovy^® 
Injectable semaglutide 2.4 mg is marketed under the brand name Wegovy^®. In the EU, Wegovy^® is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adults with a BMI of 30 kg/m² or greater (obesity) or adults with a BMI of 27 kg/m² or greater (overweight) in the presence of at least one weight-related comorbid condition. In the EU, Wegovy^® is also indicated for pediatric patients aged 12 years and older with an initial BMI at the 95^th percentile or greater for age and gender (obesity) and body weight above 60 kg. The clinical section of the label also includes data on Wegovy^® major adverse cardiovascular events (MACE) risk reduction, improvements in HFpEF-related symptoms and physical function, as well as pain reduction related to knee osteoarthritis.¹⁴

In the US, Wegovy^® (semaglutide) injection 2.4 mg is currently approved along with a reduced calorie diet and increased physical activity, for adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off and to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and either obesity or overweight.¹⁴ It is important to note that semaglutide injection 2.4 mg contains a Boxed Warning for possible thyroid tumors, including cancer and should not be used in those with a personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). 

About Novo Nordisk
Novo Nordisk is a leading global healthcare company with a heritage of more than 100 years in diabetes care. Building on this foundation, our purpose is to drive change to defeat serious chronic diseases — from diabetes and obesity to rare blood and endocrine disorders — by pioneering scientific breakthroughs, expanding access to medicines, and working to prevent and ultimately cure disease. We are committed to long‑term, responsible business practices that deliver financial, social and environmental value. Headquartered in Denmark and operating in around 80 countries, Novo Nordisk employs approximately 78,500 people and markets products in roughly 170 countries. In the United States, Novo Nordisk has a 40‑year presence, is headquartered in New Jersey and employs over 10,000 people across more than 10 manufacturing, R&D and corporate locations in eight states plus Washington, D.C. For more information, visit novonordisk.com and novonordisk‑us.com, and follow us on Facebook, Instagram, X, LinkedIn and YouTube.

Contacts for further information

References

1. Rubino D, Birkhan O, Garvey W et al. Improvements in glycemic parameters and cardiovascular risk factors with oral semaglutide 25 mg. Oral presentation presented at ObesityWeek^® 2025; 04–07 November 2025; Atlanta, Georgia. 
2. Smith I, Ivkovic M, Plotkin M et al. Oral vs. injectable semaglutide: An indirect treatment comparison of weight loss outcomes. Poster presentation presented at ObesityWeek^® 2025; 04–07 November 2025; Atlanta, Georgia. 
3. Rubino D, Birkhan O, Garvey W et al. Efficacy of oral semaglutide 25 mg in people with overweight or obesity and poor physical function. Poster presentation presented at ObesityWeek^® 2025; 04–07 November 2025; Atlanta, Georgia. 
4. Andrade M, Dunsmoor-Su R, Huvinen E et al. Semaglutide reduces body weight regardless of menopause status: STEP and OASIS 4 post hoc analysis. Poster presentation presented at ObesityWeek^® 2025; 04–07 November 2025; Atlanta, Georgia. 
5. Wharton S, Lingvay I, Bogdanski P, et al. Oral Semaglutide 25 mg in Adults with Overweight or Obesity. N Engl J Med. 2025; 393:1077-1087. DOI: 10.1056/NEJMoa2500969. 
6. Novo Nordisk A/S. Data on file.  
7. Oral Semaglutide 25 mg FDA NDA filing; Novo Nordisk data on file. 
8. Novo Nordisk Press Release. FDA accepts filing application for oral semaglutide 25 mg, which if approved, would be the first oral GLP-1 treatment for obesity. Available at: https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915988. Accessed September 2025. 
9. Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61–69.
10. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev. 2017;18(7):715–723. 
11. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1–203.
12. Centers for Disease Control and Prevention. Adult obesity facts. Available at: https://www.cdc.gov/obesity/adult-obesity-facts/index.html.  Last accessed: September 2025.
13. World Obesity Federation. World Obesity Atlas 2024. Available at: https://data.worldobesity.org/publications/WOF-Obesity-Atlas-v7.pdf. Last accessed: September 2025. 
14. Wegovy^® Prescribing information. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215256s015lbl.pdf. Last accessed: October 2025.