VESALIUS-CV Subgroup Results Show Repatha®
Reduces Risk of First Major Cardiovascular Events by 29% in People Living with High-Risk Diabetes
New Real-World Data Highlight Treatment Gaps in Current Obesity and Diabetes Care
THOUSAND OAKS, Calif., June 7, 2026 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced new data at the American Diabetes Association (ADA) 86th Scientific Sessions reinforcing its commitment to addressing unmet needs for people living with cardiometabolic conditions and improving patient outcomes.
The data include new Phase 3 VESALIUS-CV subgroup results for Repatha® in patients with high-risk diabetes (microvascular disease, insulin use or diabetic duration ≥10 years) and elevated LDL-C ("bad" cholesterol) without prior heart attack or stroke. Results from the analysis of 6,002 patients demonstrate that Repatha, when added to statins or other low-density lipoprotein cholesterol (LDL-C)-lowering therapies, reduced the risk of the composite primary endpoint of coronary heart disease death, myocardial infarction or ischemic stroke (3-P MACE) by 29% compared with placebo.
Repatha also reduced the risk of a second composite primary endpoint that included ischemia-driven revascularization (4-P MACE) by 21%. The median achieved LDL-C was 45 mg/dL in the Repatha arm compared to 106 mg/dL with placebo (898 patients in the subgroup were part of a lipid sub-study).
Approximately one-third and one-fifth of patients were on a sodium-glucose cotransporter 2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) receptor agonist, respectively, at some point during the study. Similar benefits were observed with Repatha regardless of whether patients were treated with these therapies, highlighting the importance of managing multiple risk factors in patients with high-risk diabetes, including treating uncontrolled LDL-C with Repatha.
"People with diabetes face double the risk of heart attack or stroke compared to those without the condition. These VESALIUS-CV results show that early, intensive LDL-C reduction to 45 mg/dL with Repatha is critical to help prevent life-altering cardiovascular events in those with high-risk disease," said Jay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data at Amgen. "Cardiometabolic conditions like elevated LDL-C and diabetes often coexist, compounding risk and leading to adverse outcomes. In addition to these data, Amgen is presenting real-world evidence that underscores the pressing need for continued long-term treatment to realize the full benefit of medical therapy for chronic conditions like diabetes, obesity and cardiovascular disease."
Amgen presented multiple real-world evidence studies showing that while GLP-1 therapies can provide meaningful improvements in glycemic control and body weight, these benefits are closely tied to sustained treatment use. Across studies, persistence and adherence remained low in routine clinical practice, with many patients discontinuing treatment within the first year, potentially limiting the ability to achieve guideline-recommended HbA1c and weight goals and contributing to more modest outcomes than those seen in clinical trials. These findings highlight an important need for new treatment approaches and care strategies that may help patients stay on therapy longer and realize the full potential benefits of GLP-1 medicines.
Key Amgen presentations during ADA 2026:
Repatha (evolocumab) and LDL-C
Evolocumab Reduces CV Events in Patients with High-Risk Diabetes: Results from the VESALIUS-CV Trial
Abstract #1247-OR, Sunday, June 7 from 3:45 – 4:00 p.m. CDT
These data were simultaneously published in Diabetes Care.
Lipid Management in Patients with High-Risk Diabetes Mellitus at Risk for a First Major Atherosclerotic Cardiovascular Event: Findings from the VESALIUS-REAL Global Study
Abstract #1448-P, Monday, June 8 from 12:30 – 1:30 p.m. CDT
Obesity
Real-World HbA1c and Weight Change 6 and 12 Months by GLP-1 Treatment Persistence in Adults with Type 2 Diabetes
Abstract #1665-P, Presented Sunday, June 7
Impact of GLP-1–Based Treatment Discontinuation on Weight Loss and Glycemic Goals Among Patients with Type 2 Diabetes: Quantifying an Opportunity to Improve Treatment Benefits
Abstract #1706-P, Presented Sunday, June 7
A Meta-Analysis of Persistence and Adherence to Glucagon-Like Peptide-1-Based Treatments Among Patients with Type 2 Diabetes in the United States
Abstract #1691-P, Presented Sunday, June 7
A Meta-Analysis of Real-World Effectiveness of Glucagon-Like Peptide-1s Among Patients with Type 2 Diabetes in the United States
Abstract #20-PUB, Publication
About the VESALIUS-CV Trial
VESALIUS-CV is a Phase 3, double-blind, randomized, placebo-controlled, global clinical trial designed to evaluate the impact of LDL-C lowering with evolocumab on MACE in adults at high CV risk without prior heart attack or stroke. Results were published in the New England Journal of Medicine in November 2025. Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE). Repatha also reduced the risk of heart attack by 36%.
VESALIUS-CV enrolled more than 12,000 patients with known ASCVD or high-risk diabetes, who had no history of heart attack or stroke, an LDL-C ≥ 90 mg/dL, or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 120 mg/dL, or apolipoprotein B ≥ 80 mg/dL; and treated with highest tolerated dose of statin and/or ezetimibe. The median baseline LDL-C was 122 mg/dL (IQR, 104-149 mg/dL) on local lab testing. Participants were randomized to receive Repatha or placebo in addition to optimized lipid-lowering therapy and were followed for a median of approximately 4.6 years.
Amgen's Commitment to Cardiometabolic Innovation
Amgen is redefining cardiometabolic care with cutting-edge science rooted in human biology that addresses closely connected cardiovascular and metabolic diseases that lead to serious outcomes or death.
Cardiometabolic conditions commonly coexist and can lead to serious outcomes or death, even though they are treatable.1 Despite advances in lipid-lowering and metabolic therapies, substantial residual cardiovascular risk remains, driven by persistent LDL-C elevation, genetically mediated Lp(a) and obesity-related cardiometabolic dysfunction.2
Leveraging 40+ years of cutting-edge science and human genetics, Amgen is redefining cardiometabolic care and risk management. With years of success in cardiovascular disease with Repatha, Amgen is well positioned to deliver potential breakthrough medicines like MariTide and olpasiran to help address patient needs in cardiometabolic care and multiple interconnected drivers of cardiovascular and metabolic disease.
About Repatha
Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
Repatha is one of the most extensively studied PCSK9 inhibitors, with clinical and real-world evidence across diverse populations and CV risk profiles.3 The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients.4 Repatha is the only PCSK9 inhibitor to demonstrate a significant reduction of cardiovascular events as both high-risk primary and secondary prevention, with patients achieving and maintain dramatic LDL-C reductions using Repatha only once every two weeks.5,6
Repatha was first approved in 2015 and has since been used by more than 8 million patients globally.7,8 In August 2025, the U.S. Food and Drug Administration broadened the approved use of Repatha to include adults at increased risk for major adverse CV events due to uncontrolled LDL-C. Repatha is approved in 74 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union.9 Applications in other countries are pending.
INDICATIONS
Repatha® is a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor indicated:
To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events.
As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in:
adults with hypercholesterolemia.
adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH).
The safety and effectiveness of Repatha® have not been established in pediatric patients with HeFH or HoFH who are younger than 10 years old or in pediatric patients with other types of hypercholesterolemia. For full prescribing information, visit .
IMPORTANT SAFETY INFORMATION
Contraindication: Repatha® is contraindicated in patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in Repatha®. Serious hypersensitivity reactions including angioedema have occurred in patients treated with Repatha®.
Hypersensitivity Reactions: Hypersensitivity reactions, including angioedema, have been reported in patients treated with Repatha®. If signs or symptoms of serious hypersensitivity reactions occur, discontinue treatment with Repatha®, treat according to the standard of care, and monitor until signs and symptoms resolve.
Adverse Reactions in Adults with Primary Hypercholesterolemia: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.
From a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2% and 3.0% of Repatha®-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. Hypersensitivity reactions occurred in 5.1% and 4.7% of Repatha®-treated and placebo-treated patients, respectively. The most common hypersensitivity reactions were rash (1.0% versus 0.5% for Repatha® and placebo, respectively), eczema (0.4% versus 0.2%), erythema (0.4% versus 0.2%), and urticaria (0.4% versus 0.1%).
Adverse Reactions in the FOURIER Cardiovascular Outcomes Trial: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: diabetes mellitus (8.8% Repatha®, 8.2% placebo), nasopharyngitis (7.8% Repatha®, 7.4% placebo), and upper respiratory tract infection (5.1% Repatha®, 4.8% placebo).
Among the 16,676 patients without diabetes mellitus at baseline, the incidence of new-onset diabetes mellitus during the trial was 8.1% in patients treated with Repatha® compared with 7.7% in patients that received placebo.
Adverse Reactions in Pediatric Patients with HeFH: The most common adverse reactions (>5% of patients treated with Repatha® and more frequently than placebo) were: nasopharyngitis, headache, oropharyngeal pain, influenza, and upper respiratory tract infection.
Adverse Reactions in Adults and Pediatric Patients with HoFH: In a 12-week study in 49 patients, the adverse reactions that occurred in at least two patients treated with Repatha® and more frequently than placebo were: upper respiratory tract infection, influenza, gastroenteritis, and nasopharyngitis. In an open-label extension study in 106 patients, including 14 pediatric patients, no new adverse reactions were observed.
Immunogenicity: Repatha® is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity with Repatha®.
Please
see
full Prescribing Information.
About Obesity
Obesity is a complex chronic disease influenced by genetic, behavioral and environmental factors, that increases the risk of many other serious related diseases and conditions, including type 2 diabetes, heart failure, sleep apnea, and cardiovascular disease.10,11 The worldwide prevalence of obesity more than doubled between 1990 and 2022.12 In the U.S., more than two in five adults (40.3%) are living with obesity.13 Globally, 1 billion people are living with obesity.14
Obesity is linked to a marked reduction in quality of life and an array of serious medical complications and conditions.15,16 Though leading medical organizations, including the American Medical Association and the European Health Commission, recognize obesity as a chronic disease, only 1%-3% of eligible adults in the U.S. are prescribed medication for chronic weight management.17,18,19
For more information about Amgen's approach to addressing obesity and related conditions, visit .
About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.
More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions.
Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.
For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube, Facebook, TikTok and Threads.
Amgen Forward-Looking Statements
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No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.
Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.
CONTACT: Amgen, Thousand Oaks
Madison Howard, 773-636-4910 (media)
Elissa Snook, 609-251-1407 (media)
Casey Capparelli, 805-447-1746 (investors)
REFERENCES
Eroglu T, Capone F, Schiattarella GG. The evolving landscape of cardiometabolic diseases. EBioMedicine. 2024 Nov;109:105447. doi: 10.1016/j.ebiom.2024.105447. Epub 2024 Nov 4. PMID: 39500010; PMCID: PMC11570325.
Tan SH, Wu JL, Zhuo SX, Zhang Y, Wang M. Residual risk in atherosclerotic cardiovascular disease after statin therapy: Clinical mechanisms and management strategies. World J Cardiol. 2026 Feb 26;18(2):114960. doi: 10.4330/wjc.v18.i2.114960. PMID: 41694036; PMCID: PMC12897005.
Data on File; Amgen, 2025.
Data on File; Amgen, 2025.
Ndumele, C. E., & Blumenthal, R. S. (2025). VESALIUS and the Anatomy of High-Risk Prevention. New England Journal of Medicine.
Marston, N. A., Bohula, E. A., Bhatia, A. K., et al. (2026). Evolocumab to reduce first major cardiovascular events in patients without known significant atherosclerosis and with diabetes: Results from the VESALIUS‑CV trial. JAMA.
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Health Risks of Overweight & Obesity. National Institute of Diabetes and Digestive and Kidney Diseases. . Published May 2023. Accessed April 27, 2026.
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Fryar CD, Afful J, Saif NT. Prevalence of overweight, obesity, and severe obesity among adults age 20 and over: United States, 1960–1962 through August 2021-August 2023. NCHS Health E-Stat. 2026 Feb;(111):1–7.
NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in underweight and obesity from 1990 to 2022: a pooled analysis of 3663 population-representative studies with 222 million children, adolescents, and adults. Lancet. 2024 Mar 16;403(10431):1027-1050.
Centers for Disease Control and Prevention. Consequences of Obesity. . Accessed November 12, 2024.
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