CMD22 Capital Markets Day slide image

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 | 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 DAY
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