Clinical Trial WATCH | Diabetes

Semaglutide in Patients with Obesity-Related Heart Failure and Type 2 Diabetes

This summary is intended to provide a snapshot of the original research. It is in no way a substitute for the original research article, nor is it intended to be a complete reflection of the original research. 

Originally published in NEJM, 18 April 2023

Obesity and type 2 diabetes frequently coexist in individuals with heart failure with preserved ejection fraction (HFpEF), resulting in significant symptom burden. 
However, specific therapies targeting this condition are lacking. 

In this study, 616 patients with HFpEF, a body-mass index ≥30, and type 2 diabetes were randomly assigned to receive once-weekly semaglutide (2.4 mg) or placebo for 52 weeks. 

The primary endpoints were changes in the Kansas City Cardiomyopathy Questionnaire clinical summary score (KCCQ-CSS) and body weight. Semaglutide resulted in a greater improvement in KCCQ-CSS (mean difference 7.3 points) and a higher percentage of weight loss (−9.8%) compared to placebo.

 Confirmatory secondary endpoints also favoured semaglutide, showing improvements in 6-minute walk distance, a composite endpoint of death and heart failure events, and reduction in C-reactive protein levels.  Serious adverse events were lower in the semaglutide group than the placebo group (17.7% vs 89%). 

Key takeout: In individuals experiencing obesity-related heart failure with preserved ejection fraction and type 2 diabetes, semaglutide resulted in more significant decreases in symptoms related to heart failure and limitations in physical function, along with greater weight loss compared to those receiving a placebo after one year. 
 
Registered under the STEP-HFpEF DM ClinicalTrials.gov number.
 

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