Eli Lilly has announced positive topline data from the Phase III SUMMIT clinical trial of tirzepatide injection in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.
The multicentre, randomised, double-blind, parallel, placebo-controlled trial is designed to compare the efficacy and safety of tirzepatide to placebo in patients irrespective of their type 2 diabetes status.
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It enrolled 731 participants across various countries, including the US, Argentina, Brazil, China, India, Israel, Mexico, Puerto Rico, Russia, and Taiwan.
Participants were randomised into a 1:1 ratio to receive either tirzepatide maximum tolerated dose (MTD) of 5mg, 10mg, or 15mg or a placebo.
The primary objectives of the study were to cut down the risk of the composite endpoint, which included time-to-first occurrence of urgent heart failure visit, heart failure hospitalisation, oral diuretic intensification, and cardiovascular death to study completion, and to assess changes in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline to week 52.
According to the results, tirzepatide showed statistically significant improvements in both primary endpoints.
There was a decline in heart failure risk outcomes and enhancements in heart failure symptoms and physical limitations as measured by the KCCQ-CSS, compared to placebo.
All key secondary endpoints were met.
Tirzepatide led to a 15.7% body weight reduction compared to 2.2% for placebo for the efficacy estimand, and a 13.9% reduction against 2.2% for placebo for the treatment-regimen estimand.
The safety profile of tirzepatide in the SUMMIT trial was consistent with previously reported data.
Eli Lilly plans to further evaluate the results and will subsequently submit them to the US Food and Drug Administration (FDA) and other regulatory agencies later this year.
Eli Lilly product development senior vice-president Jeff Emmick said: “HFpEF accounts for nearly half of all heart failure cases, and in the US almost 60% of those impacted also live with obesity. Despite a continuing increase in the number of people with both HFpEF and obesity, treatment options remain limited.”
In June this year, the company reported results from the Phase III SURMOUNT-OSA trials where tirzepatide demonstrated to lower the severity of moderate-to-severe OSA in obese adults.
