Investor Presentation First Nine Months of 2023
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Investor presentation
First nine months of 2023
Novo NordiskⓇ
FLOW trial investigating semaglutide 1.0 mg in patients with T2D
and chronic kidney disease was stopped early for efficacy
FLOW trial with 3534 patients with T2D and CKD
Semaglutide 1.0 mg + Standard of care
R
1:1
Placebo + Standard of care
Event driven
5 weeks
follow-up
•
Primary endpoint
• Time from randomisation to first occurrence of composite kidney
endpoint¹
Secondary confirmatory endpoints
Objective
•
Evaluate the effect of OW semaglutide 1.0 mg vs placebo on major
kidney outcomes in people with T2D and CKD on top of Soc²
Power
• The trial was powered to show a 20% risk reduction for the primary
endpoint
Interim analysis
The independent Data Monitoring Committee concluded that the
results from the interim analysis met certain pre-specified criteria
for stopping the trial early for efficacy
Next steps
• The trial will be closed down, all patients will be called in for last visit
Readout of trial results is expected in H1 2024
•
Annual rate of change in eGFR
•
• Time to first occurrence of three-point MACE (non-fatal MI, non-
fatal stroke or CV death)
.
Time to occurrence of all-cause death
Presentation of detailed data expected at a medical conference in
2024
1 Composite endpoint includes; Onset of persistent ≥50% eGFR reduction (CKD-EPI) compared with baseline, Onset of persistent eGFR <15mL/min/1.73 m2 or Renal Replacement therapy and Cardiovascular or renal death. 2Including SGLT2 inhibitors
MACE: Major adverse cardiovascular events; MI: Myocardial infarction; HF: Heart failure; CV: Cardiovascular; CVD: Cardiovascular Disease; CKD: Chronic Kidney Disease; OW: Once-weekly; T2D: Type 2 diabetes; eGFR: Estimated glomerular filtration rate; SoC:
Standard of careView entire presentation