Thursday, Eli Lilly and Company ( LLY ) released topline results from the SUMMIT phase 3 clinical trial evaluating the safety and efficacy of tirzepatide injection (5 mg, 10 mg, or 15 mg) in adults with heart failure with preserved ejection fraction (HFpEF) and obesity.

HFpEF accounts for nearly half of all heart failure cases, and in the U.S., almost 60% of those impacted also live with obesity.

HFpEF is a condition in which the heart’s left pumping chamber becomes stiff and unable to fill properly.

Tirzepatide demonstrated statistically significant improvements in both primary endpoints with a reduction in the risk of heart failure outcomes, assessed as a composite endpoint, and improvements in heart failure symptoms and physical limitations, compared with placebo.

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Tirzepatide reduced the risk of heart failure outcomes – heart failure urgent visit or hospitalization, oral diuretic intensification, or cardiovascular death by 38% compared to placebo.

All key secondary endpoints were also met, including improvement in exercise capacity as measured by the 6-Minute Walk-Test Distance (6MWD), reduction in the inflammation marker high-sensitivity C-reactive protein, and mean body weight reduction from baseline at 52 weeks.

For the efficacy estimand, tirzepatide led to a 15.7% (in a combined population of people with and without type 2 diabetes) body weight reduction compared to 2.2% for placebo.

For the treatment regimen estimand, tirzepatide led to a 13.9% body weight reduction compared to 2.2% for placebo.

The overall safety profile of tirzepatide in the SUMMIT trial was consistent with previously reported tirzepatide studies, including SURMOUNT and SURPASS.

The most frequently reported adverse events were primarily gastrointestinal and generally mild to moderate in severity. The most common adverse events for patients treated with tirzepatide were diarrhea, nausea, constipation, and vomiting.

Lilly plans to submit the SUMMIT study results to the FDA and other regulatory agencies later this year.

Price Action: LLY stock is up 3.46% at $8302.12 at the last check on Thursday.

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