Heart disease remains the number one killer globally, but the megablockbuster tirzepatide is proving it can do more than just help people lose weight – it’s now showing promise in fighting heart failure, too. In topline results from the phase 3 SUMMIT study, Lilly’s dual GIP/GLP-1 receptor agonist tirzepatide cut the risk of heart failure outcomes by 38% compared to placebo in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.
The drug not only significantly improved heart failure symptoms and physical limitations, but was also associated with a 15.7% weight loss in a combined population of people with and without type 2 diabetes. The placebo group had an average weight reduction of 2.2%. The results suggest tirzepatide could potentially become a promising treatment option for the nearly half of all heart failure cases with HFpEF.
The study tested tirzepatide in 5, 10, or 15 mg doses.
Lilly intends to seek regulatory approval for the indication. It plans on submitting the SUMMIT study data to the FDA and other regulatory agencies later in 2024.
A potential shift in treating HFpEF
Tirzepatide could potentially change the narrative around treating heart failure with preserved ejection fraction (HFpEF), especially in patients who also have obesity. In general, treating heart failure with HFpEF has proven challenging. One recent study noted that the goal of treating heart failure with preserved ejection fraction is to “reduce HF symptoms, increase functional status, and reduce the risk of hospital admission.” The study adds: “There is no clear evidence that pharmacologic therapy, diet, or other therapies reduce the risk of mortality in patients with HFpEF.”
Yet the SUMMIT trial results for tirzepatide could point to a potential paradigm shift in treating some patients with the condition.
“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, MD, PhD, senior vice president, product development, Lilly, in a press release. “Previous incretin studies in this population focused on symptoms and physical limitations. In a first-of-its-kind trial, tirzepatide reduced severity of symptoms and improved heart failure outcomes in people with HFpEF and obesity.”
Multifaceted benefits in SUMMIT
Unlike previous therapies, tirzepatide may address multiple aspects of HFpEF management simultaneously. First, it appears to reduce heart failure outcomes based on clinical data. In SUMMIT, tirzepatide cut the risk of heart failure outcomes by 38% compared to placebo. In addition, the drug significantly improved heart failure symptoms and physical limitations, based on the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score. The benefits of tirzepatide also extended to improved exercise capacity based on the 6-minute walk-test distance. Additionally, patients in the trial lost an average of 15.7% of body weight, which could potentially help with both overall cardiovascular health and HFpEF management.
Filed Under: Cardiovascular, Metabolic disease/endicrinology