Boehringer Ingelheim and Lilly expand heart failure program for Jardiance® with new exercise capacity trials

RIDGEFIELD, Conn. and INDIANAPOLIS, March 6, 2018 /PRNewswire/ — Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) today announced plans to expand their clinical trial program for Jardiance^® in chronic heart failure with the EMPERIAL clinical trials. These trials will evaluate the effect of Jardiance on exercise ability and heart failure symptoms in people with chronic heart failure independent of whether they have type 2 diabetes. EMPERIAL comprises two Phase III trials that will assess the effect of 12 weeks of treatment with Jardiance on the ability of people with heart failure to perform daily exercise.

The plans for the EMPERIAL trials follow initiation of the EMPEROR trials in March 2017. While the EMPEROR outcome trials focus on long-term morbidity and mortality outcomes in people with heart failure, the EMPERIAL functional trials will investigate possible benefits on exercise capacity and heart failure symptoms. These studies are based on data obtained from the landmark EMPA-REG OUTCOME^® trial, where the effect of Jardiance on heart failure outcomes was evaluated.

"Symptoms of heart failure can have a profound effect on quality of life, with more than three-quarters of people with heart failure finding it difficult to carry out routine activities," said Jeff Emmick, M.D., Ph.D., vice president, Product Development, Lilly Diabetes. "Currently, there are limited treatment options that can help improve the everyday lives of people living with chronic heart failure. We look forward to seeing whether Jardiance can help address this unmet need."

Heart failure is a serious condition where the heart is unable to pump enough blood around the body. It affects 26 million people worldwide, including more than 6 million Americans, and is associated with high morbidity and mortality. Approximately 50 percent of people who develop heart failure die within five years, and it is a leading cause of hospitalization in the United States and Europe.

"Boehringer Ingelheim and Lilly are committed to exploring how Jardiance can improve patient health outcomes and fill treatment gaps to serve as a broad cardiometabolic treatment option," said Thomas Seck, M.D., vice president of Clinical Development and Medical Affairs – Primary Care, Boehringer Ingelheim Pharmaceuticals, Inc. "We were encouraged by the heart failure findings with Jardiance in the EMPA-REG OUTCOME trial and look forward to the additional data from our other ongoing trials."

About EMPERIAL
EMPERIAL consists of two Phase III randomized, double-blind trials. The trials evaluate the effect of 12 weeks' treatment of once-daily Jardiance 10 mg compared with placebo on exercise ability and heart failure symptoms in patients with chronic heart failure with preserved or reduced ejection fraction.* This will be measured by the 6-minute walk test, a common measure of functional exercise capacity.

• EMPERIAL-preserved [NCT03448406]: will investigate Jardiance in patients with chronic heart failure with preserved ejection fraction (HFpEF). The study looks at a functional endpoint — how far patients can walk in 6 minutes — and at heart failure symptoms.
  • Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes
  • Anticipated number of patients: approx. 300
  • Estimated completion: 2019

• EMPERIAL-reduced [NCT03448419]: will investigate Jardiance in patients with chronic heart failure with reduced ejection fraction (HFrEF). The study looks at a functional endpoint — how far patients can walk in 6 minutes — and at heart failure symptoms.
  • Primary endpoint: Change from baseline to week 12 in exercise capacity as measured by the distance walked in 6 minutes
  • Anticipated number of patients: approx. 300
  • Estimated completion: 2019

*Ejection fraction is a measurement of the percentage of blood leaving the heart each time it contracts. During each heartbeat pumping cycle, the heart contracts and relaxes. When the heart contracts, it ejects blood from the two pumping chambers (ventricles). When the heart relaxes, the ventricles refill with blood.

HFpEF occurs when the heart muscle contracts normally but the ventricle muscles are stiff. They do not relax as they should when the ventricle fills with blood, so less blood can enter the heart compared to a normally functioning heart.
HFrEF occurs when the heart muscle does not contract effectively and less blood is pumped out to the body compared to a normally functioning heart.
Both HFpEF and HFrEF lead to similar symptoms of heart failure, specifically difficulty breathing, swelling and fatigue.

About Heart Failure
Heart failure is a progressive, debilitating and potentially fatal condition that occurs when the heart cannot pump enough blood around the body. Symptoms of heart failure include difficulty breathing, swelling — most commonly in feet, legs and ankles — and fatigue, among others. Heart failure is a prevalent disease; 26 million people around the world and more than 6 million people in the United States have chronic heart failure. There is a high unmet need in the treatment of heart failure, as approximately 50 percent of people diagnosed with heart failure will die within five years. Additionally, heart failure represents the most common cause of hospitalization among individuals aged 65 years and over in the United States and Europe. Heart failure is highly prevalent in people with diabetes, but approximately half of all people with heart failure do not have diabetes.

What is JARDIANCE? (www.jardiance.com)
JARDIANCE is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

JARDIANCE is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes who have known cardiovascular disease.

JARDIANCE is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).