Lilly (NYSE:LLY) announces positive top-line results from the SUMMIT Ophthalmology 3 trial

August 2, Eli Lilly and Company (LLY.US) announced positive top-line results from the SUMMIT-3 trial. Analysis showed that the trial met its primary endpoint and that the blockbuster drug tirzepatide reduced the risk of heart failure-related events by 38% compared to placebo in obese patients with heart failure with preserved ejection fraction (HFpEF). Lilly will continue to evaluate the SUMMIT trial and present detailed data at an upcoming medical meeting. Lilly plans to submit the results of the SUMMIT trial to the US FDA and other regulatory agencies later this year.

The SUMMIT trial is a multicenter, randomized, double-blind, parallel, placebo-controlled 3-period study designed to evaluate the efficacy and safety of tirzepatide versus placebo in obese adults with HFpEF (with or without type 2 diabetes). The trial randomly assigned 731 participants in a 1:1 ratio to receive subcutaneous injections of 5 mg, 10 mg, or 15 mg tirzepatide once weekly or placebo.

Tirzepatide is a dual agonist of the glucagon-like peptide-1 (GLP-1) and glucagons dependent insulinotropic polypeptide (GIP) receptors, which simultaneously activates the GLP-1 receptor and GIP receptor mediated signaling pathways. GIP and GLP-1 are endogenous gut hormones that regulate glucose. Tirzepatide was approved by the US FDA in May 2022 (brand name: Mounjaro) for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Tirzepatide was approved by the FDA in November 2022 (brand name: Zepbound) to help obese or overweight adults lose weight and maintain weight stability. It is noteworthy that tirzepatide was granted FDA breakthrough device designation for the treatment of obese patients with moderate to severe obstructive sleep apnea.