Novo Nordisk’s Semaglutide Achieves Major Milestone in MASH Treatment
Novo Nordisk’s Semaglutide 2.4 mg Shows Significant Results in Liver Disease Trial
ESSENCE Phase 3 trial highlights breakthrough potential in MASH treatment
SciFocus/November 1, 2024 -- Novo Nordisk has reported promising results from Part 1 of the ESSENCE trial, which examines the effects of semaglutide 2.4 mg on metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis. Semaglutide demonstrated superior improvement in both liver fibrosis and MASH resolution compared to placebo, marking a potential step forward in treating this under-addressed condition.
“We are very pleased about the ESSENCE trial results and the potential of semaglutide to help people living with MASH. This condition significantly impacts health, especially among those with obesity, highlighting an urgent need for effective treatment,” said Martin Holst Lange, Novo Nordisk’s EVP of Development.
Key Highlights
- Study Details: ESSENCE is a 240-week, double-blinded, phase 3 trial involving 1,200 adults with MASH and liver fibrosis stages 2-3.
- Primary Findings at Week 72:
- Fibrosis Improvement: 37% of semaglutide patients showed fibrosis improvement without steatohepatitis worsening (compared to 22.5% on placebo).
- MASH Resolution: 62.9% achieved steatohepatitis resolution without fibrosis worsening (vs. 34.1% on placebo).
- Safety Profile: Semaglutide 2.4 mg was well-tolerated, consistent with prior studies.
Novo Nordisk plans to seek regulatory approval in the US and EU in 2025, with detailed findings to be presented at an upcoming scientific conference. The continued ESSENCE trial will assess long-term benefits, with results expected in 2029.
This significant trial outcome positions semaglutide as a potential transformative treatment for MASH, a condition affecting over 250 million people globally. With regulatory submissions anticipated next year, semaglutide could bring much-needed relief to those grappling with advanced liver disease linked to obesity and metabolic dysfunction.
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