Semaglutide Weight Management and Cardiovascular Risk Reduction
Phase 3 trial STEP HFPEF with semaglutide 2.4 mg has been
successfully completed in Q2 2023
STEP HFPEF trial with 529 people with obesity and HFPEF
Objective:
STEP HFPEF
• Evaluate the effect on HF specific symptoms, physical function and
body weight compared with placebo
Dual primary endpoints:
Semaglutide 2.4 mg + SoC
R
Placebo + SoC
1:1
Dose escalation Treatment maintenance Follow up
16 weeks
36 weeks
5 weeks
•
Change in KCCQ from baseline to week 52
•
Change in body weight from baseline to week 52
Key secondary endpoints:
Change in 6MWD from baseline to week 52
Composite endpoint (all cause death, HHF, KCCQ, 6MWD) from
baseline to week 52
Inclusion criteria:
• BMI ≥30 kg/m2
• NYHA II-IV
•
Ejection fraction ≥45%
R: Randomisation; HF: Heart Failure; HFPEF: Heart Failure with preserved ejection fraction; SoC: Standard of care; KCCQ: Kansas City Cardiomyopathy Questionnaire; 6MWD: 6-min walking distance; HHF: Heart failure hospitalization; NYHA: New York Heart
Association classificationView entire presentation