Lilly's tirzepatide reduces heart failure risks in obese patients

Eli Lilly recently announced promising results for its dual GIP/GLP-1 receptor agonist, tirzepatide, in treating patients with heart failure with preserved ejection fraction (HFpEF) and obesity. The findings could position tirzepatide as a strong competitor to Novo Nordisk's semaglutide in improving cardiovascular outcomes.

The Phase III SUMMIT trial involved 731 adults with HFpEF and obesity, some of whom also had type 2 diabetes. The key finding was a 38% reduction in heart failure outcomes, compared to a placebo, over a median follow-up period of 104 weeks. The composite endpoint of the study included urgent heart failure visits, hospitalizations, oral diuretic intensification, and cardiovascular death.

In addition to the primary outcome, the trial also showed significant improvements in heart failure symptoms and physical limitations. These were assessed using the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from the baseline to week 52. Jeff Emmick, Lilly's senior vice president of product development, described the trial as groundbreaking, noting that tirzepatide alleviated symptoms and enhanced heart failure outcomes in this patient population.

The SUMMIT trial also achieved all key secondary endpoints. These included improved exercise capacity, as measured by the six-minute walk distance, and a reduction in high-sensitivity C-reactive protein (hsCRP) levels, an inflammation marker. Weight loss was another significant benefit, with participants losing an average of 15.7% of their body weight, compared to just 2.2% for the placebo group. 

Safety data from the SUMMIT trial indicated that tirzepatide's safety profile was consistent with previous studies. Common adverse events were primarily gastrointestinal, such as diarrhea, nausea, constipation, and vomiting, and were generally mild to moderate in severity.

Looking ahead, Lilly plans to present the comprehensive results at an upcoming medical conference and submit them to regulatory bodies, including the FDA, later this year. This could broaden tirzepatide's indications, which currently include its use under the brand names Mounjaro for type 2 diabetes and Zepbound for chronic weight management.

The positive results from the SUMMIT trial come shortly after Novo Nordisk's success with semaglutide in the cardiovascular realm. In March, the FDA expanded the indication for Wegovy (semaglutide) to lower the risk of major adverse cardiovascular events (MACE), such as heart attacks and strokes, in obese or overweight individuals with established cardiovascular risk. This approval was based on the SELECT trial, which reported a 20% reduction in MACE among obese or overweight patients without diabetes.

Furthermore, Novo Nordisk has demonstrated that semaglutide can decrease the risk of kidney disease complications, and the company plans to seek regulatory approval for this expanded use in both the US and the EU later this year.

Parallel to these developments, Lilly is exploring additional applications for tirzepatide. In April, the company revealed that the dual GIP/GLP-1 receptor co-agonist was effective in reducing sleep apnea in obese adults. Additionally, GLP-1 drugs, including tirzepatide, are being investigated as potential treatments for Alzheimer's disease.

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