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VESALIUS-CV Subgroup Results Show Repatha® Reduces Risk of First Major Cardiovascular Events by 29% in People Living with High-Risk Diabetes
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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 theAmerican 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," saidJay Bradner, M.D., executive vice president, Research and Development, Artificial Intelligence and Data atAmgen. "Cardiometabolic conditions like elevated LDL-C and diabetes often coexist, compounding risk and leading to adverse outcomes. In addition to these data,Amgenis 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."
Amgenpresented 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 Amgenpresentations duringADA2026:
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 inthe 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 inthe 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 inNovember 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
Amgenis 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,Amgenis redefining cardiometabolic care and risk management. With years of success in cardiovascular disease with Repatha,Amgenis 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 InAugust 2025, theU.S. Food and Drug Administrationbroadened 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.
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 theU.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 theAmerican Medical Associationand theEuropean Health Commission, recognize obesity as a chronic disease, only 1%-3% of eligible adults in theU.S. are prescribed medication for chronic weight management.17,18,19
For more information aboutAmgen's approach to addressing obesity and related conditions, visit https://www.amgen.com/obesity.
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.
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Data on File; Amgen, 2025.
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Data on File; Amgen, 2025.
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Ndumele, C. E., & Blumenthal, R. S. (2025). VESALIUS and the Anatomy of High-Risk Prevention. New England Journal of Medicine. https://doi.org/10.1056/nejme2515447
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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. https://doi.org/10.1001/jama.2026.3277
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Shapiro MD. Circulation. 2022;146(15):1120-1122.
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Rao SV, O'Donoghue ML, Ruel M, et al. Circulation. 2025;151(13):e771-e862.
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Health Risks of Overweight & Obesity. National Institute of Diabetes and Digestive and Kidney Diseases. https://www.niddk.nih.gov/health-information/weight-management/adult-overweight-obesity/health-risks. Published May 2023. Accessed April 27, 2026.
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World Health Organization. Obesity and overweight fact sheet. https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight. Updated March 1, 2024. Accessed May 14, 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.
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Hecker J, Freijer K, Hiligsmann M, Evers SMAA. Burden of disease study of overweight and obesity; the societal impact in terms of cost-of-illness and health-related quality of life. BMC Public Health. 2022;22:46.
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Burki T. European Commission classifies obesity as a chronic disease. Lancet Diabetes Endocrinol. 2021;9(7):[418].
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American Medical Association House of Delegates, 2013. Recognition of obesity as a disease. Resolution 420 (A-13). May 16, 2013. Chicago, USA.
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Kim C, Ross JS, Jastreboff AM, et al. JAMA. 2025;333(24):2203–2206.