Full Year 2023 Investor Presentation slide image

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 Novo NordiskⓇ
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