Novo Nordisk Highlights the Part 1 Results from P-III (ESSENCE) Study of Semaglutide to Treat MASH at AASLD 2024 - The Liver Meeting
Shots:
- The P-III (ESSENCE) study assessed semaglutide (2.4mg, QW) vs PBO in MASH adults (n=1,200) with liver fibrosis (stage 2/3), for 240wks., with part 1 aiming to show improved liver histology at 72wks. in first 800 randomized patients, while part 2 assessing long-term liver-related outcomes
- Study met its 1EP, depicting steatohepatitis resolution without fibrosis worsening in 62.9% vs 34.1% & improved fibrosis without steatohepatitis worsening in 37% vs 22.5%. 2EPs showed both steatohepatitis resolution & improved fibrosis in 32.8% vs 16.2%
- Trial also depicted histological benefits & improvements in non-invasive tests, liver enzymes (ALT, AST & GGT) as well as the ELF test. Filing for the US FDA’s approval is planned in H1’25
Ref: Novo Nordisk | Image: Novo Nordisk
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