Phase 2 trial reveals significant improvement in MASH patients
Boehringer Ingelheim has unveiled promising results from a Phase II trial of survodutide, demonstrating a notable improvement in liver fibrosis among patients.
The sub-analysis indicated that up to 64.5% of adults with moderate to advanced scarring (fibrosis stages F2 and F3) experienced an improvement without worsening metabolic dysfunction-associated steatohepatitis (MASH), compared to 25.9% with placebo after 48 weeks of treatment.
The findings, presented at the European Association for the Study of the Liver Congress (EASL) 2024 and published in The New England Journal of Medicine, also showed that up to 52.3% of adults treated with survodutide achieved a significant improvement in liver scarring across stages F1 to F3, versus 25.8% with placebo.
Dr. Arun Sanyal, Professor of Medicine at Virginia Commonwealth University School of Medicine and Principal Investigator of the trial, said: “I am particularly excited about the findings of the phase 2 trial in survodutide, which demonstrate the potential for glucagon agonism, in addition to GLP-1, to both improve MASH and shift the needle on fibrosis.”
Survodutide, a glucagon/GLP-1 receptor dual agonist, is the first to exhibit such a level of fibrosis benefit in a phase 2 MASH trial.
The drug’s mechanism, which includes increasing energy expenditure and impacting liver directly, could contribute to fibrosis improvement, while its GLP-1 agonist component decreases appetite and increases satiety.
These results position survodutide as a potential game-changer for individuals living with MASH and clinically significant fibrosis, offering hope for a condition that affects over 115 million people worldwide and can lead to severe complications.
These include the risk of liver cancer and the need for liver transplantation. The trial also demonstrated significance versus placebo for all other secondary endpoints after 48 weeks of treatment.
