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STEP-HFpEF DM Trial: Obesity Medication Proves Effective in Treating Patients with Heart Failure and Type 2 Diabetes

Presented by the lead author Mikhail Kosiborod, MD; Vice President, Research; Co-Director, Haverty Cardiometabolic Center of Excellence; Executive Director, Cardiometabolic Center Alliance; Ben McAllister, MD, Endowed Chair; and Professor of Medicine, University of Missouri–Kansas City

Dr. Kosiborod presented the main results of STEP-HFpEF DM trial at the American College of Cardiology Scientific Session in Atlanta, Georgia. The results have been published in the New England Journal of Medicine at the time of the presentation.

“Obesity forms a ‘common soil’ that can lead to the development of heart failure with preserved ejection fraction and Type 2 diabetes, and patients living with both conditions suffer from an especially high symptom burden but have few available treatment options,” said Dr. Kosiborod, lead study investigator and cardiologist at Saint Luke’s Mid America Heart Institute. “Today’s results, especially when combined with those from the STEP-HFpEF trial, open a new chapter of targeting obesity as a new and effective treatment strategy in patients with obesity-related HFpEF, both with and without diabetes.”

About STEP-HFpEF DM trial

The primary objective of STEP HFpEF DM trial was to investigate the effects of semaglutide 2.4 mg subcutaneous once-weekly on symptoms, physical function, and body weight compared with placebo in patients with obesity-related HFpEF and Type 2 Diabetes. STEP HFpEF included 616 people with symptomatic HFpEF (ejection fraction ≥45%) and obesity (BMI ≥30 kg/m2). Dual primary endpoints were change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline to week 52 and change in body weight from baseline to week 52; with key secondary endpoints of change in 6-Minute Walking Distance (6MWD) from baseline to week 52, hierarchical composite endpoint (all cause death, heart failure events, difference in KCCQ-CSS change and difference in 6MWD change from baseline to week 52), and change in C-reactive protein from baseline (screening) to week 52.

The trial demonstrated that compared with placebo, once-weekly semaglutide 2.4 mg produced much greater reductions in heart failure-related symptoms and physical limitations, improved exercise function, and led to greater weight loss in adults with obesity-related heart failure with preserved ejection fraction (HFpEF) and type 2 diabetes. In addition, semaglutide reduced the levels of inflammation and congestion; there were also fewer heart failure hospitalizations and urgent visits in the semaglutide group compared with placebo.

The previously published STEP HFpEF trial—another study of 529 participants with obesity-related HFpEF but without Type 2 diabetes—also showed larger reductions in heart failure-related symptoms and physical limitations, greater improvement in exercise function, and greater degree of weight loss with semaglutide versus placebo.

Learn more about the STEP-HFpEF DM Trial by reading the article in The New England Journal of Medicine and learn about the pooled results of both studies by reading the article in The Lancet.

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About Saint Luke's Cardiovascular Research

Industry-Leading Clinical Research
Clinical research is the foundation for improving patient care. Saint Luke’s uses leading-edge research to advance cardiovascular medicine, always with the goal of benefiting the patient, continuously striving to improve outcomes and patients' quality of life.

Advancing Cardiovascular Medicine
At Saint Luke’s Mid America Heart Institute, our research programs span multiple key areas, including cardiac transplantation, electrophysiology, cardiac imaging, preventative cardiology, and cardiometabolic disease.

In addition to supporting clinical research, Saint Luke's has centers of cardiovascular excellence and core laboratories in cardiovascular outcomes and cardiometabolic research; health economics and technology assessment; intravascular imaging; and noninvasive imaging.

Our program is truly comprehensive, from preventive care to treating the most complex and serious conditions.

A Leader In Cardiovascular Research
In recent years, Saint Luke’s researchers have annually published more than 300 peer-reviewed scientific articles in well-respected medical journals such as the New England Journal of Medicine, Journal of American Medical Association, The Lancet, Circulation, and the Journal of the American College of Cardiology.

The Heart Institute serves as one of four designated data analytic centers for the American College of Cardiology and the National Cardiovascular Data Registry, and is leading multiple global trials across different therapeutic areas.

Significant Accomplishments In Research

Actively involved in more than 100 clinical trials
Pioneers in Interventional Cardiology
- First Balloon Angioplasty
- First Transcatheter Aortic Valve Replacement (TAVR) in Midwest
- Leaders in Complex Coronary interventions
Developed the international standards for quantifying patient-centered outcomes
- Development of the Kansas City Cardiomyopathy Questionnaire
- Development of the Seattle Angina Questionnaire
- Development of the Peripheral Artery Questionnaire
International, practice-changing ISCHEMIA Trial
Leaders in the field of Cardiometabolic Disease
- Central in studying SGLT2 inhibitors—first entirely novel class of medication in the past two decades to be approved for the treatment of heart failure across the entire range of ejection fractions
- Leading the Design and Execution of numerous clinical trials of SGLT2 inhibitors with impact for international guidelines and clinical practice: DEFINE HF, PRESERVED HF
- EMBRACE-HF, DAPA-HF, DELIVER, EMPULSE
- DARE-19
- Cardiometabolic Center of Excellence, and Cardiometabolic Center Alliance
- First-of-a-kind decentralized trial (CHIEF-HF)
Educating the next generation of clinicians and investigators
- Advanced fellowships in all domains of cardiology
- NIH-funded T32 in Cardiovascular Quality and Outcomes Research
- Ben McCallister, MD, Clinical Scholar Program

About Saint Luke's Mid America Heart Institute

Saint Luke’s Mid America Heart Institute offers some of the most comprehensive heart and vascular care in the nation. Ranked in the top 50 in the country for cardiology, heart, and vascular surgery by U.S. News & World Report, the experts at the Heart Institute use the latest technology, research, and innovations to treat the full range of cardiovascular services, from disease prevention to heart transplantation.

With more specialized physicians, more experience, and more innovative treatment options, the Heart Institute is the third hospital in the U.S. to achieve Comprehensive Cardiac Center certification from The Joint Commission. Saint Luke's is proud to help advance cardiovascular care in the nation.

Media Headlines

Apr. 8, 2024

Good Morning America: New Report on the Effect of Weight Loss Drugs on Heart Disease

A new study led by Dr. Mikhail Kosiborod found patients with obesity-related heart failure and diabetes had a significant improvement in symptoms when taking semaglutide.

Apr. 8, 2024

CNN: Weight-Loss Drug Wegovy Offers Benefits for People with Diabetes and Common Form of Heart Failure, Study Finds

The popular weight loss drug Wegovy seems to provide more health benefits for people who have diabetes and a common kind of heart failure than just helping take off the pounds, according to the results from the STEP HFpEF DM trial.