Jardiance phase 3 exercise ability studies in chronic heart failure fail to meet primary endpoint

Jardiance, a type 2 diabetes drug developed by Boehringer Ingelheim and Eli Lilly and Company (Lilly), failed to meet the primary endpoint of two late-stage exercise ability trials in chronic heart failure.

The two phase 3 trials for Jardiance called EMPERIAL-Reduced and EMPERIAL-Preserved were carried out in adults with chronic heart failure with reduced and preserved ejection fraction, respectively.

In the two trials, treatment with the type 2 diabetes drug could not deliver any significant change from baseline to week 12 in exercise ability compared to placebo, as measured by the six-minute walk test. This was defined as the primary endpoint of the two EMPERIAL trials.

The two phase 3 studies used the six-minute walk test, which measures the distance walked by a person in six minutes, to assess changes in exercise ability over a period of 12 weeks.

Lilly said that the safety profile observed in the EMPERIAL trials was identical to the currently known safety profile of Jardiance with no new safety risks identified.

According to the company, the EMPERIAL clinical trials, which enrolled people with and without diabetes, provide new safety data for the drug in non-diabetic patients with heart failure. Apart from that, the company said that EMPERIAL-Preserved is the first trial to generate safety data for the type 2 diabetes drug in heart failure with preserved ejection fraction.

Lilly product development vice president Jeff Emmick said: "The EMPERIAL trials highlight our commitment to listening to patients’ needs and studying the impact of our treatments on important measures such as quality of life.

"Boehringer Ingelheim and Lilly will continue to explore how Jardiance can potentially improve health outcomes and fill treatment gaps for people with cardiorenal metabolic conditions, including adults with chronic heart failure."

Lilly expects to release the full results from the EMPERIAL trials in 2020.

Last month, Boehringer Ingelheim and Lilly initiated the EMPULSE trial, the sixth phase 3 study in the Jardiance heart failure programme. The EMPULSE trial will evaluate if in-hospital administration of Jardiance 10mg daily can improve heart failure outcomes when given in people hospitalised for any type of acute heart failure event after they have been stabilised.

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