- In November 2024, Novo Nordisk announced the key findings from part 1 of the ongoing ESSENCE trial, a pivotal phase 3, 240-week, double-blind study involving 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis (stages 2 or 3). Part 1 of the trial assessed the impact of once-weekly semaglutide 2.4 mg on liver tissue (histology) compared to a placebo, alongside standard care, for the first 800 participants over 72 weeks. Novo Nordisk plans to seek regulatory approvals in the US and EU in the first half of 2025
- In June 2024, Eli Lilly and Company announced the detailed results from the SYNERGY-NASH Phase 2 study, which involved 190 patients, with or without type 2 diabetes, to evaluate the investigational use of tirzepatide in adults with biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) and stage 2 or 3 fibrosis. The efficacy results revealed the achievement of absence of MASH with no worsening of fibrosis on liver histology, compared to 13.2% in the placebo group after 52 weeks of treatment. This outcome met the study’s primary endpoint
- In March 2024, Madrigal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Rezdiffra (resmetirom) as an adjunct to diet and exercise for treating adults with non-cirrhotic NASH and moderate to advanced liver fibrosis (stages F2 to F3 fibrosis). NASH, also referred to as metabolic dysfunction-associated steatohepatitis (MASH), is a liver disease characterized by inflammation and fat buildup
- In March 2024, Ionis Pharmaceuticals, Inc. announced positive results from a Phase 2 study of ION224, an investigational DGAT2 antisense inhibitor being developed for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). The study successfully met its primary endpoint at both the 120 mg and 90 mg doses, demonstrating liver histological improvement. In addition, it achieved the key secondary endpoint of MASH resolution
- In February 2024, Boehringer Ingelheim announced that up to 83.0% of adults treated with survodutide (BI 456906) demonstrated a statistically significant improvement in metabolic dysfunction-associated steatohepatitis (MASH) compared to 18.2% in the placebo group in a Phase II trial. primary endpoint, with survodutide showing a biopsy-confirmed improvement in MASH The trial achieved its after 48 weeks, without worsening fibrosis in stages F1, F2, and F3 (mild to moderate or advanced scarring. Survodutide has the potential to become a leading treatment for MASH, a liver disease linked to cardiovascular, renal, and metabolic conditions
