Investor Presentation Full Year 2021 slide image

Investor Presentation Full Year 2021

86 Investor presentation Full year 2021 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. OW + 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 Liver transplant Structure Part 1 Part 2 I • I I I 1 I 72 weeks 240 weeks Biopsy Biopsy Biopsy • 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; OW: 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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