Unique Community-Based Partnership With the Association of Black Cardiologists and Morehouse School of Medicine to Identify Study Sites and Participants

Observational Study to Better Understand Associations Between Lp(a) Levels and Atherosclerotic Cardiovascular Disease (ASCVD) in an Underrepresented Patient Population

THOUSAND OAKS, Calif., Feb. 22, 2023 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the African American Heart Study, in collaboration with the Association of Black Cardiologists (ABC) and the Morehouse School of Medicine (MSM), which will measure the association between Lipoprotein(a), or Lp(a), and atherosclerotic cardiovascular disease (ASCVD) in 5,000 African American individuals across the United States. ASCVD is defined as the buildup of cholesterol plaque in arteries and includes events such as heart attack and stroke.

"The African American Heart Study is a unique collaborative study including community outreach in partnership with trusted organizations to help improve our understanding of the disproportionate higher incidence of Lp(a) and cardiovascular disease progression in African Americans and hopefully provide insights of ways to address barriers in clinical trial access," said Ponda Motsepe-Ditshego, M.D., vice president, global medical and head of Amgen's Representation in Clinical Research team. "At Amgen, our mission is to serve patients, and important to that mission is expanding clinical trial access and diverse representation in the community setting to provide a full picture of how a disease impacts certain groups."

Cardiovascular disease is the number one killer of all Americans, and the cardiovascular risk for African Americans is even higher. According to the U.S. Department of Health and Human Services, African Americans are 30% more likely to die from heart disease than non-Hispanic whites.^1-2

Lp(a) is a presumed independent risk factor for heart disease; levels are genetically determined and are known to differ by race and ethnicity.^3-6 African American individuals show a higher average Lp(a) concentration than white populations, but Lp(a) research to date has primarily been conducted in individuals of European descent.⁷ This leaves the association between Lp(a) levels and incident ASCVD in persons of African American descent uncertain and important to investigate further to understand drivers of cardiovascular risk in African Americans. Amgen has initiated the African American Heart Study to bridge this gap.   

"People of all races and ethnicities can have high levels of Lp(a), but it appears to be more common in African Americans. I am excited about the African American Heart Study because we have the opportunity to study up to 5,000 self-identified African Americans, who have been so often underrepresented in studies, in order to gain a better understanding of the genetic underpinnings of Lp(a) and to determine if African American patients are at a higher risk of cardiovascular disease," said Elizabeth Ofili, M.D., M.P.H., FACC, professor of medicine at Morehouse School of Medicine and principal investigator of the study. "The results of this study will potentially provide insights that will help determine which types of patients would benefit most from future therapy."

This prospective case-control study design will enroll 2,500 self-identified African Americans with ASCVD and 2,500 self-identified African Americans without ASCVD from cardiology and primary care practices across the United States. Enrollment is voluntary. ABC and MSM will conduct community outreach, as well as identify sites through the Health 360x Clinical Trial Network and Registry. The Health 360x Network practice sites are trusted providers, crucial to the success of the African American Heart Study. The Health 360x Clinical Trial Network and Registry is funded by the National Institutes of Health to support clinical trials in community-based practices.⁹

Amgen's subsidiary, deCODE genetics, based in Iceland, with its world-class human genetics capabilities, will sequence and analyze DNA, RNA, and protein markers from participants' blood samples. With three years of follow-up planned, the broad omics data analyzed by deCODE will help Amgen broaden the understanding of ASCVD and other diseases that disproportionately affect African Americans. The learnings may also inform future clinical trials and drug development.

"Increasing the diversity in our clinical trials is essential to achieving our ambition of serving all patients. This requires us to think differently than we have in the past about how we design and conduct our trials," said Rob Lenz, M.D., Ph.D., senior vice president, Global Development at Amgen. "To do that, we are educating the community on why this is critical and building trusted relationships with our partners. We also are training external investigators and building new capabilities that will help provide them with the right infrastructures in communities of underserved patient populations to make projects like the African American Heart Study possible."

The African American Heart Study is emblematic of Amgen's unwavering commitment to diversity in clinical trials. In 2020, Amgen launched its Representation in Clinical Research team to accelerate its work in promoting diversity in clinical trials and is focused on improving clinical trial diversity and proportional representation by addressing the systemic issues that deter people from participating in research, especially those who have been historically excluded due to race, ethnicity, sex, age, and other factors.

About the African American Heart Study
The main objective of the study is to determine associations between Lp(a) levels, sequence variants, clinical factors and cardiovascular outcomes in African Americans. Participants will be followed for at least three years leveraging real-world evidence from electronic health records.

About Lp(a)
Lp(a) is genetically determined and presumed to be an independent risk factor for cardiovascular disease (CVD). ^4-6 Although an agreed upon threshold for elevated Lp(a) is not firmly established, it has been estimated that approximately 20% of adults have Lp(a) >125 nmol/L (or approximately 50 mg/dL).^3-6 Evidence has emerged from pathophysiological, epidemiologic, and genetic studies on the potential role of elevated Lp(a) in contributing to myocardial infarction, stroke, and peripheral arterial disease.^3-8

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. 

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. 

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2022, Amgen was named one of the "World's Best Employers" by Forbes and one of "America's 100 Most Sustainable Companies" by Barron's.

For more information, visit Amgen.com and follow us on Twitter, LinkedIn, Instagram, TikTok and YouTube.

About deCODE genetics
Based in Reykjavik, Iceland, deCODE genetics, is a global leader in analyzing and understanding the human genome. Using its unique expertise and population resources, deCODE has discovered genetic risk factors for dozens of common diseases. The purpose of understanding the genetics of disease is to use that information to create new means of diagnosing, treating and preventing disease. deCODE is a wholly-owned subsidiary of Amgen (NASDAQ:AMGN).

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CONTACT: Amgen, Thousand Oaks 
Michael Strapazon, 805-313-5553 (media)
Jessica Akopyan, 805-440-5721 (media)
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