Eli Lilly declares positive data from Phase III HFpEF treatment trial

Eli Lilly has announced positive results from the Phase III SUMMIT trial of tirzepatide in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. The trial showed significant improvements in both primary endpoints.

The trial, which included 731 participants from various countries, compared tirzepatide (5mg, 10mg, or 15mg) to a placebo. It aimed to reduce the risk of composite heart failure events and assess changes in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) over 52 weeks.

Tirzepatide led to a 15.7% reduction in body weight versus 2.2% with placebo and improved heart failure risk outcomes and symptoms. All key secondary endpoints were met, and the safety profile was consistent with previous data. Eli Lilly plans to submit these results to the FDA and other regulatory agencies later this year.