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Boehringer Ingelheim (BI) and Eli Lilly and Company have announced plans to conduct a new, large clinical outcomes trial investigating empagliflozin (Jardiance) tablets for the treatment of people with chronic kidney disease. The drug significantly reduced the risk of kidney disease progression in the EMPA-REG OUTCOMES trial.

The announcement was made at the 77th American Diabetes Association’s (ADA) Scientific Sessions last week.

The landmark EMPA-REG OUTCOME trial demonstrated that empagliflozin reduced the risk of cardiovascular death by 38 percent versus placebo in people with type 2 diabetes and established cardiovascular disease when added to standard of care (including glucose-lowering agents and cardiovascular drugs).

As one of the secondary endpoints, the trial also showed that empagliflozin reduced the risk for new-onset or worsening of kidney disease by 39 percent versus placebo when added to standard of care in adults with type 2 diabetes and established cardiovascular disease.

Based on these results, BI and Lilly decided to formally investigate the potential of empagliflozin in people with chronic kidney disease.

The goal of the new trial is to gather evidence in support of a potential new indication for empagliflozin in people with chronic kidney disease.  Empagliflozin recently received a new indication from the FDA for reducing the risk of cardiovascular death in patients with type 2 diabetes.

Trial design

“This is a new outcome study to evaluate the effect of Jardiance for the treatment of people with chronic kidney disease and is based on cardiovascular and renal insights from the landmark EMPA-REG OUTCOME trial,” Thomas Seck, Vice President of US Clinical Development and Medical Affairs Primary Care at Boehringer Ingelheim told Drug Discovery & Development in an email.

The new trial will enroll approximately 5,000 people with chronic kidney disease—both with and without type 2 diabetes.

“This trial is designed to assess Jardiance’s effects on renal and cardiovascular outcomes in patients with chronic kidney disease,” said Seck.

When asked if the study will assess the potential mechanisms behind the effects of empagliflozin, he said “previous studies have already suggested potential mechanisms of how Jardiance may impact renal outcomes – including a reduction in glomerular pressure. The study might also shed light into potential mechanisms, but is not primarily designed for this purpose.”

About 15 percent of adults in the United States are affected by chronic kidney disease—and about two-thirds of chronic kidney disease cases are attributed to metabolic diseases such as diabetes, hypertension and obesity. There are currently only a few treatment options for the disease so Boehringer Ingelheim and Eli Lilly hope empagliflozin can meet this unmet medical need for new treatments.

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