Eli Lilly has reported comprehensive outcomes from the Phase III SUMMIT trial of tirzepatide for individuals with heart failure with preserved ejection fraction (HFpEF) and obesity.
The double-blind, multi-centre, randomised, parallel, placebo-controlled study involved 731 participants who were randomised to receive either tirzepatide or placebo.
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Subjects were randomised across multiple countries, including Argentina, Taiwan, Brazil, China, India, Israel, Mexico, Puerto Rico, Russia, and the US.
It met both primary endpoints, with tirzepatide showing a 38% decrease in heart failure outcomes risk compared to placebo. Hospitalisation for heart failure risk was also reduced by 56%.
Additionally, the therapy led to significant improvements in heart failure symptoms and physical limitations with subjects experiencing a nearly 25-point increase in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS), compared to a 15-point improvement for those on placebo.
Tirzepatide-treated patients reported improved exercise capacity, walking approximately 30 metres farther in six minutes than those who received placebo.
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By GlobalDataFurthermore, patients on tirzepatide saw an average body weight reduction of 15.7% against 2.2% in the placebo group. A reduced high-sensitivity C-reactive protein (hsCRP) level of 43.4% is also observed.
Eli Lilly product development senior vice-president Jeff Emmick said: “Cardiometabolic diseases such as heart failure and obesity are closely linked and often coexist. New approaches are needed to address the interrelated nature of these diseases.
“At Lilly, we want to better understand the root causes of these conditions and how they impact each other so we’re better able to treat them. Currently, no treatments are available specifically for obesity-related HFpEF in the US.”
Tirzepatide’s overall safety profile in the SUMMIT trial was consistent with previous studies, with the most frequently reported adverse events being primarily gastrointestinal and mild to moderate in severity generally.
Following these results, the company has submitted tirzepatide for HFpEF and obesity treatment to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), with plans to submit to other regulatory authorities at the end of the year.
Lilly recently reported outcomes from the SURMOUNT-1 study of tirzepatide for treating pre-diabetic and obese individuals.
