On Saturday, Eli Lilly And Co LLY released detailed results from the SUMMIT Phase 3 trial showing tirzepatide reduced the risk of worsening heart failure events in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.
The 731-patient SUMMIT study showed that patients treated with tirzepatide also experienced improvements in heart failure symptoms and physical limitations.
The FDA approved tirzepatide as Mounjaro for adults with type 2 diabetes to improve glycemic control in May 2022 and Zepbound for adults with obesity or those who are overweight who also have at least one weight-related medical problem in November 2023.
The results from the SUMMIT trial of tirzepatide in obese patients with heart failure with preserved ejection fraction (HFpEF) showed that Lilly’s drug cut the risk of cardiovascular mortality and worsening heart failure events by 38% over a median follow-up of roughly two years.
After a median follow-up of two years and a maximum of three years, cardiovascular death or worsening heart failure events occurred in 9.9% of the tirzepatide group and 15.3% of those taking a placebo.
Assessing individual endpoints, worsening heart-failure events occurred in 8% of tirzepatide participants and 14.2% of placebo participants, for an HR of 0.54 (95% CI, 0.34-0.85), whereas adjudicated cardiovascular deaths occurred in 2.2% and 1.4% of tirzepatide and placebo participants, respectively.
The risk of hospitalization for heart failure was reduced by 56%.
In addition, patients taking tirzepatide saw a nearly 25-point improvement in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), which measures symptoms and physical limitations associated with heart failure, compared to a 15-point improvement for the placebo group.
All key secondary endpoints were also met, with patients treated with tirzepatide demonstrating improved exercise capacity, walking approximately 30 meters farther in six minutes than those on placebo (38.2 meters vs. 7.9 meters).
Additionally, patients treated with tirzepatide saw an average reduction in body weight of 15.7%, compared to 2.2% in the placebo group.
Tirzepatide also significantly decreased high-sensitivity C-reactive protein, a key marker of systemic inflammation, by 43.4%, while the placebo group saw a 3.5% decrease.
Lilly said it has already started submitting the SUMMIT data to the FDA and European Medicines Agency regulators for HFpEF and obesity, seeking to extend the labeling for tirzepatide.
Price Action: LLY stock is down 2.54% at $727.27 at last check Monday.
Photo via Shutterstock
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