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In New SELECT Trial Analysis, Early Reduction in Cardiovascular Events Was Observed with Wegovy®, Before Clinically Meaningful Changes in Body Weight

PLAINSBORO, N.J., May 13, 2025 /PRNewswire/ -- Today, Novo Nordisk will present data at the European Congress of Obesity (ECO) from a secondary, post hoc analysis of the SELECT trial that showed within the first three months of treatment, reductions in the risk of MACE in adults with obesity and established cardiovascular disease (CVD) were seen.2 Reductions were also observed within six months in the risk of dying from CVD or being hospitalized or needing urgent medical attention due to heart failure.2

According to the secondary, post hoc analysis which will be presented during an oral session at ECO, there was a significant reduction in the risk of MACE observed with Wegovy® within the first three months of treatment compared to placebo, on top of standard of care (HR 0.63; 95% CI 0.41, 0.95). Similar early efficacy estimates were observed over the first six months for cardiovascular (CV) death. Data showed that within six months of treatment, a reduction in risk of CV death was observed for patients taking Wegovy® related to CV death (HR 0.50; 95% CI 0.26, 0.93); lowered composite heart failure risk (HR 0.41; 95% CI 0.24, 0.67), and reduced death from any cause (HR 0.60; 95% CI 0.36, 1.01).2 The widths of the confidence intervals have not been adjusted for multiplicity and therefore the confidence intervals should not be used to infer definitive treatment effects for this secondary analysis.

"Cardiovascular disease is linked to two thirds of obesity-related deaths, and with obesity on the rise, there is an urgent need for effective treatments. Building on the landmark SELECT trial, that showed that semaglutide 2.4 mg decreased heart disease events in people with overweight or obesity and established cardiovascular disease, in this secondary analysis, there was early reduction in heart disease events observed with semaglutide 2.4 mg prior to what is typically considered significant weight loss," said Dr. Jorge Plutzky, lead study author and Director of Preventive Cardiology at Brigham and Women's Hospital.

Safety data collection in the SELECT trial was limited to serious adverse events (including death), adverse events leading to discontinuation, and adverse events of special interest.1 In the SELECT trial, the proportion of patients for whom serious adverse events were reported was 33.4% in patients randomized to Wegovy® 2.4 mg and 36.4% of patients receiving placebo.1 Sixteen percent (16%) of Wegovy® 2.4 mg-treated patients and 8% of placebo-treated patients, respectively, discontinued study drug due to an adverse event.1 The most common adverse event leading to discontinuation was gastrointestinal disorders, occurring in 10% of patients in the Wegovy® 2.4 mg group and 2% in the placebo group.1

"For people with obesity and existing cardiovascular disease, preventing another heart attack or stroke is vitally important. Seeing this SELECT secondary data demonstrate that patients experienced MACE risk reduction within three months is remarkable," said Dr. Jason Brett, MD, Principal Medical Head at Novo Nordisk Inc. "These latest findings add to the growing evidence on the effect of Wegovy® in addressing cardiovascular disease."

About obesity and cardiovascular disease
Obesity is a chronic disease that requires long-term management.5 It is associated with many serious health consequences and decreased life expectancy.6 Obesity-related complications are numerous and include type 2 diabetes, chronic kidney disease, metabolic dysfunction-associated steatotic liver disease, cancer, high levels of cholesterol, blood pressure, and an increased risk of CV disease, including heart attack and stroke.5,7,8

CVD is the leading cause of death in the U.S.9 More than 800,000 people die from CVD each year in the U.S. (1 in every 3 deaths).4

About the SELECT trial
SELECT was a multicenter, randomized, double-blind, placebo-controlled, event-driven superiority trial designed to evaluate the efficacy of semaglutide 2.4 mg versus placebo as an adjunct to cardiovascular standard of care for reducing the risk of major adverse cardiovascular events (cardiovascular death, non-fatal heart attack, or non-fatal stroke) in adults with established CVD with overweight or obesity with no prior history of diabetes.1 In SELECT, established CVD was defined as a prior heart attack, prior stroke, or symptomatic PAD.1

The trial, initiated in 2018, enrolled 17,604 adults and was conducted in 41 countries at more than 800 investigator sites.1

About Novo Nordisk
Novo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.

References

  1. Lincoff MA, Brown-Frandson K, Colhoun HM, et al. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med. 2023;389:2221-2232.
  2. Plutzky J, Ostrominski J, Aroda V, et al. Early clinical benefit of semaglutide in adults with overweight or obesity and cardiovascular disease: A secondary analysis of the SELECT trial. Oral presentation presented at the European Congress on Obesity; 11-14 May 2025; Palacio De Ferias Y Congresos De Málaga, Magala, Spain. Presentation AD15.04.
  3. Collaborators GBDO, Afshin A, Forouzanfar MH, et al. Health effects of overweight and obesity in 195 countries over 25 years. N Engl J Med. 2017;377:13-27.
  4. MillionHearts. Costs & Consequences. Last accessed: April 2025. Available at: https://millionhearts.hhs.gov/learn-prevent/cost-consequences.html.
  5. 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.
  6. Centers for Disease Control and Prevention. How overweight and obesity impacts your health. Last accessed: April 2025. Available at: http://cdc.gov/healthy-weight-growth/food-activity/overweight-obesity-impacts-health.html?CDC_AAref_Val=https://www.cdc.gov/healthyweight/effects/index.html.
  7. Powell-Wiley, Tiffany M., et al. "Obesity and cardiovascular disease: a scientific statement from the American Heart Association." Circulation, vol. 143, no. 21, 25 May 2021.
  8. Centers for Disease Control and Prevention. Obesity and cancer. Last access: April 2025. Available at: https://www.cdc.gov/cancer/risk-factors/obesity.html.
  9. Centers for Disease Control and Prevention. Leading causes of death. Last accessed: April 2025. Available at: https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm.

SOURCE NOVO NORDISK INC.

Posted: May 2025

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