CMD22 Capital Markets Day
6
Commercial execution and innovation
NASH and Alzheimer's disease
Novo Nordisk®
Following phase 2 data and breakthrough therapy designation,
one phase 3 trial is expectedly needed for regulatory submission
Phase 3a ESSENCE trial in NASH
ESSENCE trial | NASH F2-F3 patients
N = 1,200
Semaglutide 2.4 mg sc. OW + SoC
Fixed
follow-up
R
2:1
Placebo + SoC
Primary objectives and endpoints for Part 1 and 2
Part 1 | Improves liver histology vs placebo
Two binary histology endpoints at week 72:
•
•
Resolution of NASH and no worsening of liver fibrosis
Improvement in liver fibrosis and no worsening of NASH
Part 2 | Lowers the risk of liver-related clinical events vs placebo
Time to first outcome (composite endpoints) at week 240:
•
•
Histological progression to cirrhosis
Death (all cause)
Liver-induced MELD score ≥ 15
Structure
.
Part 1
Part 2
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I
I
I
I
I
I
72 weeks
240 weeks
Biopsy
Biopsy
Biopsy
•
Liver transplant
•
Hepatic decompensation events
Regulatory submission expected to be based on part 1 of the trial
combined with the results of the already completed phase 2 trial
F: Fibrosis stage; NASH: non-alcoholic steatohepatitis; OW: once weekly; R: randomisation; SoC: standard of care (GLP-1s disallowed); MELD: Model for End-stage Liver Disease; BTD: Break-through Designation
CMD22
CAPITAL MARKETS DAYView entire presentation