Novo Nordisk's GLP-1 agonist Wegovy (semaglutide) has received US regulatory clearance for metabolic dysfunction-associated steatohepatitis (MASH) with moderate-to-advanced fibrosis (F2-F3), marking the first approval for this liver disease. The decision was based on Phase III ESSENCE trial data where 2.4mg weekly dosing showed 36.8% fibrosis improvement without MASH worsening versus 22.4% for placebo at 72 weeks, alongside 62.9% MASH resolution rates.

The approval expands Wegovy's indications beyond obesity and cardiovascular risk reduction, addressing a US patient population exceeding 22 million. ESSENCE's 240-week Part 2 continues to evaluate long-term liver-related clinical outcomes, with results expected in 2029. Novo Nordisk CSO Martin Holst Lange highlighted Wegovy's unique dual action in halting disease progression and reversing liver damage in MASH, which affects one-third of overweight/obese individuals globally.

According to PharmCube's NextBiopharm® database, Novo is the top sponsor of GLP-1/1R clinical trials in MASH among over 30 competitors. Click here to request a free trial for NextBiopharm®.