Phase 2 study reveals significant improvements in MASH patients
Boehringer Ingelheim announced encouraging results from a Phase 2 trial of sulvodutide, demonstrating significant improvements in patients’ liver fibrosis.
Sub-analyses showed that after 48 weeks of treatment, up to 64.5% of adults with moderate to advanced scarring (fibrosis stages F2 and F3) experienced improvement without worsening of metabolic dysfunction-associated steatohepatitis (MASH), compared with 25.9% on placebo.
The findings will be presented at the European Association for the Study of the Liver (EASL) in 2024. New England Journal of MedicineThe study also showed that up to 52.3% of adults who received sulvodutide achieved significant improvement in liver scarring ranging from stages F1 to F3, compared with 25.8% who received a placebo.
“I am particularly excited by the results of the Phase 2 study of sulvodutide, which shows that a glucagon agonist in addition to GLP-1 may improve MASH and alter fibrosis,” said Arun Sanyal, PhD, professor at Virginia Commonwealth University School of Medicine and the study’s principal investigator.
Survodutide, a dual glucagon/GLP-1 receptor agonist, is the first agent to demonstrate this level of antifibrotic efficacy in the Phase 2 MASH trial.
The drug’s mechanism of action involves increased energy expenditure and direct effects on the liver, which may contribute to ameliorating fibrosis, while the GLP-1 agonist component reduces appetite and increases satiety.
These results suggest that sulvodutide may be a breakthrough treatment for people with MASH and clinically significant fibrosis, offering hope for a disease that affects more than 115 million people worldwide and can lead to severe complications.
These include the risk of liver cancer and the need for a liver transplant. The study also showed significance compared to placebo in all other secondary endpoints after 48 weeks of treatment.
