Full Year 2023 Investor Presentation
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Investor presentation
Full year 2023
Novo NordiskⓇ
The STEP HFPEF-DM trial was successfully completed in Q4 2023
and 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
Status:
•
Completion of STEP HFPEF-DM trial in November 2023
• Combined (including STEP HFpEF trial) regulatory submission of both
trials in H1 2024
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 classificationView entire presentation