Lilly's tirzepatide succeeds in phase 3 trial for heart failure with preserved ejection fraction and obesity

Eli Lilly and Company has released promising results from its SUMMIT phase 3 clinical trial investigating the use of tirzepatide injections in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. Tirzepatide, administered in doses of 5 mg, 10 mg, or 15 mg, showed significant benefits over placebo in reducing the risk of adverse heart failure outcomes and improving symptoms and physical limitations.

The trial's primary endpoints were achieved, with tirzepatide reducing the risk of heart failure outcomes by 38% compared to placebo. The composite endpoint included urgent heart failure visits, heart failure hospitalizations, oral diuretic intensification, and cardiovascular death. Additionally, tirzepatide significantly enhanced heart failure symptoms and decreased physical limitations, as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS).

Key secondary endpoints were also met. These included an improvement in exercise capacity as gauged by the 6-Minute Walk-Test Distance (6MWD), a reduction in the inflammation marker high-sensitivity C-reactive protein (hsCRP), and a substantial mean body weight reduction at the 52-week mark. Specifically, participants on tirzepatide experienced a 15.7% weight loss compared to 2.2% for those on the placebo for the efficacy estimand. For the treatment-regimen estimand, the weight reduction was 13.9% compared to 2.2% for placebo.

Dr. Jeff Emmick, senior vice president of product development at Lilly, highlighted the significance of these findings, particularly given the limited treatment options for the nearly 60% of HFpEF patients in the U.S. who also struggle with obesity. Tirzepatide's ability to improve both heart failure outcomes and symptoms marks a notable advancement.

The SUMMIT trial included 731 participants from multiple countries, such as the U.S., Argentina, Brazil, China, India, Israel, Mexico, Puerto Rico, Russia, and Taiwan. Participants were randomized in a 1:1 ratio to receive either tirzepatide or a placebo once weekly. The dosage of tirzepatide was gradually increased from an initial 2.5 mg to a maximum tolerated dose of either 5 mg, 10 mg, or 15 mg, depending on individual tolerance levels.

Concerning safety, the adverse events reported in the SUMMIT trial were consistent with those observed in previous tirzepatide studies. Most side effects were gastrointestinal in nature, including diarrhea, nausea, constipation, and vomiting, typically mild to moderate in severity.

Eli Lilly plans to present the complete results of the SUMMIT trial at an upcoming medical conference and aims to submit the findings to a peer-reviewed journal. Additionally, the company intends to submit the study results to the U.S. Food and Drug Administration (FDA) and other regulatory bodies later this year.

Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist, combining the effects of these natural incretin hormones to regulate appetite and improve glycemic control. Approved by the FDA under the brand names Mounjaro for type 2 diabetes and Zepbound for obesity, tirzepatide has shown potential in reducing food intake and modulating fat utilization. Further studies on its efficacy in treating chronic kidney disease and morbidity/mortality in obesity are ongoing.

As the healthcare community awaits more detailed data, tirzepatide's positive impact on heart failure symptoms and weight reduction offers a new avenue for managing HFpEF and obesity, conditions that have seen limited treatment options to date.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!