Try our mobile app
In a first-of-its-kind study, tirzepatide also alleviated heart failure symptoms and physical limitations
Patients on tirzepatide experienced improved exercise capacity, greater weight loss and reduced systemic inflammation
Lilly has initiated submissions for tirzepatide for the treatment of HFpEF and obesity to global regulatory agencies
INDIANAPOLIS, Nov. 16, 2024 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from the SUMMIT Phase 3 trial showing tirzepatide significantly reduced the risk of worsening heart failure events in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. Patients treated with tirzepatide also experienced notable improvements in heart failure symptoms and physical limitations. The results were published in The New England Journal of Medicine simultaneously with a presentation at the American Heart Association (AHA) Scientific Sessions 2024.
Both primary endpoints were met. Tirzepatide showed a 38% reduction in the risk of heart failure outcomes, assessed as a composite endpoint, compared to placebo. 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),1 which measures symptoms and physical limitations associated with heart failure, compared to a 15-point improvement for the placebo group.2
"Many studies point to obesity as a major contributor to the development and severity of heart failure with a preserved ejection fraction through its effects to promote systemic and myocardial inflammation," said Milton Packer, M.D., distinguished scholar in cardiovascular science at Baylor University Medical Center at Dallas and visiting professor at Imperial College, London (steering committee chair). "The SUMMIT trial provides important insights as to how healthcare providers could have a meaningful impact on the clinical course and quality of life of patients with HFpEF and obesity."
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).2 Additionally, patients treated with tirzepatide saw an average reduction in body weight of 15.7%, compared to 2.2% in the placebo group.2 Tirzepatide also significantly decreased high-sensitivity C-reactive protein (hsCRP), a key marker of systemic inflammation, by 43.4%, while the placebo group saw a 3.5% decrease.2
Full Results:
Primary Endpoint: Time-to-first occurrence of heart failure outcomes
| ||
Relative risk reduction of time-to-first occurrence of heart failure outcomes (median follow up of 104 weeks):
| -38%Hazard Ratio=0.62 95% CI 0.41 to 0.95; P=0.026 | |
Tirzepatide MTD | Placebo | |
Heart Failure Outcomes* | 36 (9.9%) | 56 (15.3 %) |
Cardiovascular death** | 10 (2.7 %) | 5 (1.4 %) |
Adjudicated CV death | 8 (2.2 %) | 5 (1.4 %) |
Undetermined cause | 2 (0.5 %) | 0 |
Heart failure events | 29 (8 %) | 52 (14.2 %) |
Hospitalization for heart failure | 12 (3.3 %) | 26 (7.1 %) |
Urgent visit for heart failure | 5 (1.4 %) | 12 (3.3 %) |
Oral diuretics intensification for heart failure | 17 (4.7 %) | 21 (5.7 %) |
Primary Endpoint: Improvements in heart failure symptoms and physical limitations from baseline as measured by the change from baseline in KCCQ-CSS (points)
| ||
Estimated median difference at 52 weeks | 6.9 95% CI 3.3 to 10.6; P
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc. | |
