Full Year 2023 Investor Presentation
104
Investor presentation
Full year 2023
Phase 3a trial ESSENCE with semaglutide 2.4 mg for the
treatment of MASH was initiated in Q1 2021
The phase 3a ESSENCE trial in MASH
ESSENCE trial | MASH F2-F3 patients
N = 1,200
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 MASH and no worsening of liver fibrosis
Semaglutide 2.4 mg sc. QW + SOC
Fixed
follow-up
R
2:1
Placebo + SoC
Structure
I
Part 1
Part 2
I
I
72 weeks
I
Biopsy
Biopsy
240 weeks
Biopsy
.
Improvement in liver fibrosis and no worsening of MASH
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
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; MASH: Metabolic dysfunction-associated 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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