Eli Lilly $LLY announced today that the drug behind Zepbound was found to help cut heart failure risks in patients with obesity in a late-stage clinical trial. The medication, tirzepatide, is sold by the company in the United States as Mounjaro for diabetes and Zepbound for weight loss.
The pharma giant said on Thursday that it’s planning to submit the results to the U.S Food and Drug Administration (FDA) later this year, which could lead the agency to expand the use of the drug to include treating heart failure. That could open up access to the medication. If regulators expand the approved use of Zepbound the medication could join Novo Nordisk’s Wegovy in being covered by Medicare.
The company’s stock jumped nearly 4% during Wednesday pre-market trading.
The trial involved 731 participants with obesity and heart failure with preserved ejection fraction (HFpEF), a condition where the left ventricle doesn’t contract normally and results in not enough blood circulating in the body. Half of the group was given tirzepatide over the course of 52 weeks, the other half was given a placebo.
Patients who received tirzepatide were 38% less likely to be hospitalized, need an increase in heart failure medication, or die of heart failure, compared to patients who were given a placebo.
“HFpEF accounts for nearly half of all heart failure cases, and in the U.S. almost 60% of those impacted also live with obesity,” said Jeff Emmick, senior vice president of product development at Eli Lilly, in a statement. “Despite a continuing increase in the number of people with both HFpEF and obesity, treatment options remain limited.”
A path to Medicare coverage
The promising results could become a pathway for Zepbound to be covered by federal health insurance in the United States. In March, the U.S. Centers for Medicare and Medicaid Services (CMS) issued new guidance stating that “anti-obesity medications that receive FDA approval for an additional medically accepted indication can be considered a Part D drug for that specific use.”
The guidance was issued after U.S. regulators expanded the approved use of Wegovy to include reducing heart risks for adults who are obese or overweight.
Eli Lilly said in April that tirzepatide was also found to help alleviate sleep apnea in a late-stage clinical trial.