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Eli Lilly’s blockbuster diabetes and obesity drug tirzepatide has achieved good results in a Phase III trial of the medication in adults with heart failure with preserved ejection fraction and obesity.
The company announced that the joint glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) agonist met its two primary endpoints in the study and also met secondary endpoints.
Tirzepatide was approved by the FDA to treat type 2 diabetes in 2022 and obesity in 2023 and has since become a blockbuster drug, particularly for treatment of obesity.
However, the benefits of tirzepatide are broader than reduction in blood sugar and weight loss and the treatment is being tested to assess its benefits for treating a number of different obesity or diabetes associated conditions such as metabolic dysfunction-associated steatohepatitis, obstructive sleep apnea and heart failure.
In the SUMMIT Phase III trial, injection with tirzepatide (5 mg, 10 mg or 15 mg) was tested as a possible treatment for heart failure with preserved ejection fraction in obese patients with the condition.
The first primary objective was a reduction in a composite of time-to-first urgent heart failure hospital visit, heart failure hospitalization, oral diuretic treatment intensification and cardiovascular death before the end of the study. The second was a positive change in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score from the beginning of the trial until week 52.
The first primary endpoint was reduced by 38% vs. placebo and the Kansas score improved by 6–10 points over placebo. Safety results were similar to those seen in other studies of tirzepatide.
Secondary endpoints in the study were also met. For example, improvement in exercise capacity measured by the Six-Minute Walk-Test Distance, reduction in the inflammation marker high-sensitivity C-reactive protein, and mean body weight reduction from baseline at 52 weeks.
“Heart failure with preserved ejection fraction accounts for nearly half of all heart failure cases, and in the U.S. almost 60% of those impacted also live with obesity. Despite a continuing increase in the number of people with both [conditions], treatment options remain limited,” said Jeff Emmick, senior vice president, product development, at Lilly, in a press statement.
“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.”
Lilly plans to submit the results of this study to the FDA and other regulatory agencies towards the end of this year with a view to expanding indications in which tirzepatide can be used.
News & FeaturesAntidiabetic agentsDiabetesHeart failureObesityPhase III clinical trials (Drug development)