Lilly obesity drug proves heart benefit in late trial

Eli Lilly's tirzepatide, marketed as Zepbound for weight loss, has demonstrated significant cardiovascular benefits in late-stage testing. The Phase 3 study, known as SUMMIT, revealed that tirzepatide reduces the risk of death or serious complications from heart failure by 38% in individuals with obesity, some of whom also had diabetes. Additionally, the treatment resulted in meaningful improvements in heart failure symptoms, assessed through a widely accepted evaluation method. Secondary outcomes were also favorable, showing improvements in a walking test and reductions in inflammation markers.

The company disclosed only the top-level results of the study. Detailed findings will be presented at a medical conference and published in a peer-reviewed journal later. The successful trial may help Lilly broaden the use of tirzepatide, as the company intends to share the data with regulatory authorities this year. These promising findings add to the expanding list of applications for incretin drugs, which are currently approved for diabetes, weight loss, and, in the case of Novo Nordisk's competitor drug Wegovy, reducing heart risk. Recent studies suggest these drugs are beneficial in other health conditions like sleep apnea, chronic kidney disease, and MASH, a common liver condition.

For Eli Lilly, the trial results help maintain competitiveness with Novo Nordisk, which has already demonstrated Wegovy's benefits in the same type of heart failure. However, Wegovy is not yet approved for this specific use. Unlike Novo Nordisk, Lilly focused its trial on the reduction of heart failure complications as a primary goal rather than an exploratory one. This strategic design could strengthen Lilly's case to insurers for covering tirzepatide for heart failure treatment.

Leerink Partners analyst David Risinger praised the results, noting they were "very impressive" compared to previously tested drugs for HFpEF (heart failure with preserved ejection fraction). Lilly’s Jardiance, an SGLT2 inhibitor recommended for HFpEF, showed a 21% reduction in death or hospitalization risk in a large study, while Novartis' Entresto showed a 13% reduction, narrowly missing statistical significance. Risinger also pointed out that tirzepatide's impact on symptom scores appeared comparable to Wegovy, although comparing drugs across different trials can be misleading due to varying study designs.

HFpEF accounts for about half of all heart failure cases. In the U.S., nearly 60% of individuals with HFpEF are also obese, according to Jeff Emmick, Lilly's senior vice president of product development. Despite the rising number of people suffering from both HFpEF and obesity, treatment options remain limited, he added.

Lilly reported that tirzepatide's safety profile was consistent with prior studies. Common side effects included gastrointestinal issues like diarrhea, nausea, constipation, and vomiting, which were generally mild to moderate in severity. The company is also conducting other outcome studies to determine if tirzepatide can prevent heart problems in people with cardiovascular disease. One study focusing on individuals with Type 2 diabetes is expected to yield results next year, while another study on obese individuals is anticipated to conclude in 2027.

Last year, Novo Nordisk’s Wegovy succeeded in an outcomes trial involving people with cardiovascular disease who are also obese or overweight. This led the FDA to broaden Wegovy’s label, giving Novo Nordisk an advantage with insurers.

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