Lilly’s Tirzepatide Reduced Heart Failure and Obesity Symptoms in Phase 3 Trial

Terzepatide © Josh - stock.adobe.com

Eli Lilly and Company announced today the results of a phase 3 SUMMIT trial, which assessed tirzepatide in adults with heart failure with preserved ejection fraction (HFpEF) and obesity. Tirzepatide resulted in a 15.7% weight loss for people with and without type 2 diabetes when compared with placebo, which only led to a 2.2% reduction.

In the trial, tirzepatide reduced the risk of heart failure outcomes – heart failure urgent visit or hospitalization, oral diuretic intensification or cardiovascular death – by 38% compared with placebo

“HFpEF accounts for nearly half of all heart failure cases, and in the U.S. almost 60% of those impacted also live with obesity,” Jeff Emmick, M.D., Ph.D, senior vice president, product development, Lilly said in the news release. “Despite a continuing increase in the number of people with both HFpEF and obesity, treatment options remain limited. Previous incretin studies in this population focused on symptoms and physical limitations. In a first-of-its-kind trial, tirzepatide reduced severity of symptoms and improved heart failure outcomes in people with HFpEF and obesity.”

HFpEF is a condition in which the left side of the heart stiffens and cannot pump blood properly. Nearly 7 million people in the United States are affected by heart failure. In 2022, it was responsible for almost 14% of deaths, according to data from Centers for Disease Control and Prevention.

The SUMMIT study consisted of 731 participants from the United States, Argentina, Brazil, China, India, Israel, Mexico, Puerto Rico, Russia and Taiwan. Patients were started at a dose of 2.5 mg which gradually increased every four weeks until a maximum tolerated dose was reached for each person. The highest dose possible was 15 mg.

Improvements were seen in exercise stamina and inflammation reduction was seen in the high-sensitivity C-reactive protein, which indicates inflammation.

The most common side effects reported from injections were diarrhea, nausea, vomiting and constipation. Doses administered included 5mg, 10mg and 15mg.

Tirzepatide has already been approved by the U.S. Food and Drug Administration (FDA) as Mounjaro for adults with type 2 diabetes and as Zepbound for adults with obesity. Both are prescribed along with exercise and healthy eating habits.

Tirzepatide has a dual function, working to signal the pancreas to release insulin as well as mimicking GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide) hormones that decrease appetite.

Researchers had two main objectives going into the study. They wished to see change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, which measures heart function, from baseline to week 52 and improvement in heart failure symptoms.

Study results will be submitted to the FDA later this year.