▎WuXiEdited by Kant Content Team

Today, Eli Lilly and Company announced positive topline results from the SUMMIT Phase 3 clinical trial.Analysis shows that the trial met the primary endpoint,Compared with placebo, Eli Lilly's blockbuster drug tirzepatide reduced the risk of heart failure-related events by 38% in patients with obesity and heart failure with preserved ejection fraction (HFpEF).Eli Lilly will continue to evaluate the SUMMIT trial and announce detailed data at an upcoming medical conference.Eli Lilly plans to submit the results of the SUMMIT study to the U.S. FDA and other regulatory agencies starting later this year.

SUMMIT is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3 study designed to evaluate the efficacy and safety of tirzepatide compared to placebo in adult patients with obesity and HFpEF (with or without type 2 diabetes).The trial was conducted at a 1:1:1 ratio randomly assigned 731 subjects to receive once-weekly doses of 5 mg, 10 mg, or 15 mg.tirzepatide, or placebo subcutaneous injection.

Analysis shows that, compared with placebo,Tirzepatide demonstrated statistically significant improvements in both primary endpoints, namely reducing the risk of heart failure events.(Including emergency visits or hospitalizations for heart failure, intensified oral diuretic therapy, or cardiovascular death),As measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS), showing improvement in patients' heart failure symptoms and physical limitations., see the table below for details.

▲TIrzepatide Reduces ObesityRisk of Heart Failure Events in HFpEF Patients (Image Source: Reference [1])

In addition, analysisAlso showed that the trial met all key secondary endpoints, includingImprovement in exercise capacity as measured by the 6-minute walk test distance (6MWD), reduction in the inflammatory marker high-sensitivity C-reactive protein (hsCRP), and mean weight loss from baseline at 52 weeks.Tirzepatide led to a 15.7% weight loss in patients with and without type 2 diabetes, compared to 2.2% in the placebo group.

The overall safety of tirzepatide in the SUMMIT trial was consistent with previously reported trial results. The most common adverse events reported in the trial were primarily gastrointestinal adverse events, includingDiarrhea, nausea, constipation, and vomiting,The severity is generally mild to moderate.

Tirzepatide is aGlucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1)A dual receptor agonist that can simultaneously activate signaling pathways mediated by GLP-1 and GIP receptors.GIP and GLP-1 are natural incretin hormones that regulate blood sugar. Tirzepatide was approved by the United States in May 2022.FDA Approval(Product name: Mounjaro), used in conjunction with controlled diet and exercise to improve blood sugar control in adult patients with type 2 diabetes. In November last year, tirzepatide receivedFDA Approval(Product name: Zepbound), used to help obese or overweight adult patients lose weight and maintain stable weight. Notably, tirzepatide was granted Fast Track designation by the FDA for the treatment of moderate to severeObstructive Sleep ApneaObese patients.