Eli Lilly’s Tirzepatide Shows Reduction in Risk of Heart Failure Outcomes
Phase III study of tirzepatide in adults with heart failure with preserved ejection fraction and obesity met all primary endpoints.
According to new data revealed by Eli Lilly, tirzepatide significantly improved heart failure symptoms and physical limitations in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. Data emerged from the Phase III SUMMIT clinical trial, which met both of its primary endpoints as well as key secondary endpoints.1
Tirzepatide also improved exercise capacity, reduced the inflammation marker high-sensitivity C-reactive protein (hsCRP), and displayed a mean body weight reduction from baseline at 52 weeks. In a combined population of people with and without type 2 diabetes, tirzepatide led to 15.7% weight loss.
Heart failure is typically classified based on the contraction of the heart muscle or the filling of the heart chambers. When the heart muscle is too weak, the condition is known as HFpEF. A number of chronic medical conditions can cause this condition including obesity, high blood pressure, chronic obstructive pulmonary disease, and sleep apnea.2
In a press release, Jeff Emmick, MD, PhD, senior vice president, product development, Lilly said, “HFpEF accounts for nearly half of all heart failure cases, and in the U.S. 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. 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.”
The Phase III Summit trial (NCT04847557) was a multi-center, randomized, double-blind, parallel, placebo-controlled study. It randomized 731 participants across the US, Argentina, Brazil, China, India, Israel, Mexico, Puerto Rico, Russia, and Taiwan in a 1:1 ratio to receive tirzepatide in an injection of 5 mg, 10 mg or 15 mg, or placebo.
Earlier in June, results from the Phase III SURMOUNT-OSA (NCT05412004) clinical trial, published in The New England Journal of Medicine showed treatment with tirzepatide was found to improve sleep-related patient-reported outcomes, apnea–hypopnea index scores, body weight, hypoxic burden, high-sensitivity C-reactive protein concentration, and systolic blood pressure in patients with moderate-to-severe obstructive sleep apnea (OSA) and obesity.3
“Symptoms of [OSA] represent a substantial disease burden and increased risk of injury, including increased risk of motor vehicle accidents and work-related injuries,” the study authors wrote. “The symptom severity in [OSA] may also be a predictor of increased risk of cardiovascular complications. Therefore, it is clinically relevant that in the current trials, positive effects of tirzepatide on the participants’ sleep-related functioning and sleep disturbance were detected on the basis of PROMIS-SRI and PROMIS-SD scores.”
The FDA approved tirzepatide for chronic weight management in November 2023 based on Phase III results from the SURMOUNT-1 and SURMOUNT-2 trials.4
In an earlier press release, Leonard Glass, MD, FACE, senior vice president global medical affairs, Lilly Diabetes and Obesity said, “Unfortunately, despite scientific evidence to the contrary, obesity is often seen as a lifestyle choice—something that people should manage themselves. For decades, diet and exercise have been a go-to, but it's not uncommon for a person to have tried 20-30 times to lose weight with this approach. Research now shows that the body may respond to a calorie-deficit diet by increasing hunger and reducing feelings of fullness, making weight loss more difficult. Lilly is aiming to eliminate misperceptions about this disease and transform how it can be managed.”
References
1. Lilly's tirzepatide successful in phase 3 study showing benefit in adults with heart failure with preserved ejection fraction and obesity. News release. Eli Lilly. August 1, 2024. Accessed August 5, 2024. https://investor.lilly.com/news-releases/news-release-details/lillys-tirzepatide-successful-phase-3-study-showing-benefit
2. Heart Failure with Preserved Ejection Fraction (HFpEF). Frankel Cardiovascular Center, University of Michigan Health. Accessed August 5, 2024. https://www.umcvc.org/conditions-treatments/heart-failure-preserved-ejection-fraction-hfpef
3. Tirzepatide Produces Clinically Meaningful Improvement in Symptoms of Obstructive Sleep Apnea. Applied Clinical Trials. June 26, 2024. Accessed August 5, 2024. https://www.appliedclinicaltrialsonline.com/view/tirzepatide-produces-clinically-meaningful-improvement-symptoms-obstructive-sleep-apnea
4. FDA Approves Lilly's Zepbound™ (tirzepatide) for Chronic Weight Management, a Powerful New Option for the Treatment of Obesity or Overweight with Weight-Related Medical Problems. News release. Eli Lilly. November 8, 2023. Accessed August 5, 2024. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-zepboundtm-tirzepatide-chronic-weight
Driving Diversity with the Integrated Research Model
October 16th 2024Ashley Moultrie, CCRP, senior director, DEI & community engagement, Javara discusses current trends and challenges with achieving greater diversity in clinical trials, how integrated research organizations are bringing care directly to patients, and more.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
