DCRI to Partner with Boehringer Ingelheim and Eli Lilly on new Pragmatic Trial

The indication-seeking trial is the first in the SGLT2 inhibitor class to investigate whether empagliflozin can be used to prevent heart failure after a heart attack.

Boehringer Ingelheim and Eli Lilly and Company (NYSE:LLY) today announced an academic research collaboration with the Duke Clinical Research Institute (DCRI) on a new trial, EMPACT-MI (EMPAgliflozin for the prevention of Chronic heart failure and morTality after an acute Myocardial Infarction). The collaboration will investigate whether Jardiance® (empagliflozin) can improve outcomes and prevent heart failure in adults with and without diabetes who have had an acute myocardial infarction, more commonly known as a heart attack. This randomized clinical trial will be conducted, analyzed and reported in partnership with the DCRI, with Boehringer Ingelheim and Lilly providing funding. To conduct the trial, the DCRI will partner closely with the Canadian VIGOUR Centre, an academic research organization committed to the advancement of cardiovascular health.

EMPACT-MI will include approximately 3,300 adults across at least 16 countries who have had an acute myocardial infarction. The primary endpoint of the trial is to assess the effect of Jardiance on all-cause mortality and hospitalization for heart failure. The trial will be part of the EMPOWER program, the broadest and most comprehensive clinical trial program exploring the impact of Jardiance on the lives of people with cardio-renal-metabolic conditions.

“This collaboration represents an important step in understanding how to safeguard and protect the lives of patients with acute myocardial infarction,” said Adrian Hernandez, MD, MHS, co-chair of the EMPACT-MI trial and DCRI executive director. “Myocardial infarction is the leading cause of death in cardiology, and this is the first trial in the SGLT2 inhibitor class to investigate the potential to increase survival and decrease progression to heart failure in people who have had a recent myocardial infarction.”

Javed Butler, MD, MPH, MBA, chair of the EMPACT-MI trial and professor and chairman of the Department of Medicine at the University of Mississippi, added, “We are delighted to lead the EMPACT-MI trial to find out whether Jardiance could become a new standard of care option to improve the outcomes and lives of people with acute myocardial infarction.”

Pragmatic clinical trials focus on the relationship between treatments and outcomes in real-world health system practice. This partnership will leverage the DCRI’s experience in pragmatic trials by implementing innovative and efficient trial elements, including remote follow-up and a focused data collection approach, which enable a strong patient focus while maintaining high data quality.

“We are pleased to collaborate with the Duke Clinical Research Institute on the EMPACT-MI trial to investigate the potential to increase survival and prevent heart failure from developing in adults who have had a heart attack. Despite current therapies, these patients have a high residual risk that could be addressed by the multiple benefits we have observed with SGLT2 inhibition,” said Waheed Jamal, MD, corporate vice president and head of CardioMetabolic Medicine, Boehringer Ingelheim.

“The EMPACT-MI trial is part of our broad and comprehensive clinical development program, which aims to explore how Jardiance can improve health outcomes and fill therapeutic gaps for a broad range of patients suffering from cardio-renal-metabolic conditions,” said Jeff Emmick, MD, PhD, vice president, Product Development, Lilly.