STEP-HFpEF
Semaglutide Treatment Effect in People with obesity and HFpEF
Patient / Population Intervention / Exposure Comparison Outcome
In 529 patients with HFpEF (EF ≥ 45%) and obesity (BMI ≥ 30) without diabetes, semaglutide 2.4 mg improved heart-failure symptoms (KCCQ) and body weight compared with placebo.
N
529
Design
Double-blind placebo-controlled RCT
Endpoint
Dual primary: change in KCCQ Clinical Summary Score and percentage change in body weight at 52 weeks
Relevance
2
ResultKCCQ-CSS +16.6 vs +8.7 (difference 7.8 points, 95% CI 4.8-10.9; P<0.001); body weight -13.3% vs -2.6% (difference -10.7 points, 95% CI -11.9 to -9.4; P<0.001).
Kosiborod MN, et al. N Engl J Med. 2023;389(12):1069-1084. 10.1056/NEJMoa2306963
Discussion & critique
Symptom/weight surrogate endpoints in non-diabetic patients over one year, not powered for HF events. Reframed obesity-phenotype HFpEF as a treatable cardiometabolic disease and drove GLP-1 agonists into HFpEF management.