Investor Presentation H1 2023
80
Investor presentation
First six months of 2023
The ongoing STEP HFPEF-DM trial is to be included in the
regulatory submission
STEP HFPEF-DM trial with 610 people with obesity, HFPEF and T2D
Trial design and next steps
Dual primary endpoints:
•
Change in KCCQ from baseline to week 52
Semaglutide 2.4 mg + SoC
R
1:1
Placebo + SoC
•
Change in body weight from baseline to week 52
Inclusion criteria:
• BMI ≥30 kg/m2
• NYHA II-IV
Ejection fraction ≥45%
Dose escalation Treatment maintenance Follow up
16 weeks
.
HbA1c ≤10.0%
36 weeks
5 weeks
Next steps:
•
Completion of STEP HFPEF-DM trial expected in H2 2023
• Combined regulatory submission of both trials in H1 2024
• Decision expected late 2024/early 2025
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; NYHA: New York Heart Association classification
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