“We plan to submit results to the FDA and other regulatory agencies starting later this year.”

In context

“an follow-up for this endpoint was 104 weeks. In the second primary endpoint, tirzepatide significantly improved heart failure symptoms and physical limitations compared to placebo as measured by the Kansas City Cardiomyopathy Questioner, KCCQ Clinical Summary score. Main changes from baseline in this measurement is 24.8 points for tirzepatide, while placebo was 15 points based on the efficacy as demand at 52 weeks. All key secondary endpoints were met in the study, including mean body weight reduction of 15.7% 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. We will present detailed results at an upcoming medical -- and submit to a peer-reviewed journal. We plan to submit results to the FDA and other regulatory agencies starting later this year. In other updates across our portfolio, Slide 15 shows select pipeline opportunities as of August 6. Slide 16 shows potential key events for the year. I'll start with updates in cardiometabolic health, which is the new name of our internal business, formerly known as Lilly diabetes and obesity. In June, we published detailed results for our Phase 3 trials of tirzepatide for the treatment of moderate to severe obstructive sleep apnea and obesity in the New England Journal of Medicine, and we presented results at the American Diabetes Association Meeting. All primary and key secondary endpoints were achieved in these studies. Notably, in one of our key secondary endpoints, as shown on Slide 17, tirzepatide demonstrated that up to 51.5% of participants met the criteria for disease resolution”