STEP-HFpEF
Trial question
What is the role of semaglutide in patients with HFpEF and obesity?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
56.0% female
44.0% male
N = 529
529 patients (297 female, 232 male)
Inclusion criteria: patients with HFpEF and a BMI ≥ 30 kg/m²
Key exclusion criteria: diabetes mellitus; patient-reported change in body weight > 5 kg within 90 days before screening
Interventions
N=263 semaglutide (2.4 mg once weekly for 52 weeks)
N=266 placebo (matching placebo for 52 weeks)
Primary outcome
Mean improvement in Kansas City Cardiomyopathy Questionnaire clinical summary score at week 52
16.6
8.7
16.6 points
12.5 points
8.3 points
4.2 points
0.0 points
Semaglutide
Placebo
Significant
increase ▲
Significant increase in mean improvement in Kansas City Cardiomyopathy Questionnaire clinical summary score at week 52 (16.6 points vs. 8.7 points; AD 7.8 points, 95% CI 4.8 to 10.9)
Secondary outcomes
Significant increase in mean reduction in body weight at week 52 (13.3% vs. 2.6%; AD 10.7%, 95% CI 9.4 to 11.9)
Significant increase in mean improvement in 6-minute walk distance at week 52 (21.5 m vs. 1.2 m; AD 20.3 m, 95% CI 8.6 to 32.1)
Significant decrease in mean reduction in CRP level at week 52 (43.5% vs. 7.3%; TR 0.61, 95% CI 0.51 to 0.72)
Safety outcomes
Significant difference in serious adverse events (13.3% vs. 26.7%).
Conclusion
In patients with HFpEF and a BMI ≥ 30 kg/m², semaglutide was superior to placebo with respect to mean improvement in Kansas City Cardiomyopathy Questionnaire clinical summary score at week 52.
Reference
Mikhail N Kosiborod, Steen Z Abildstrøm, Barry A Borlaug et al. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. 2023 Sep 21;389(12):1069-1084.
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