Investor Presentation First Nine Months of 2022
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Investor presentation First nine months of 2022
Phase 3a trial ESSENCE with semaglutide 2.4 mg for the
treatment of NASH was initiated in Q1 2021
The phase 3a ESSENCE trial in NASH
ESSENCE trial | NASH F2-F3 patients
N = 1,200
Semaglutide 2.4 mg sc. QW + SOC
R
2:1
Placebo + SoC
Fixed
follow-up
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
I
•
I
I
I
1
I
72 weeks
240 weeks
Biopsy
Biopsy
Biopsy
•
Liver transplant
•
Hepatic decompensation events
Regulatory submission is 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; QW: once-weekly; R: randomisation; SoC: standard of care (GLP-1 RAS disallowed); MELD: Model for End-stage Liver Disease
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