Clinical Trials

The trial demonstrated that 83% of adults treated with the drug achieved a statistically significant improvement of MASH compared to placebo (18.2%). The trial met its primary endpoint of reaching a biopsy-proven improvement in MASH after 48 weeks, without the worsening of fibrosis stages F1, F2 and F3 (mild-to-moderate or advanced scarring).

The drug also met all of its secondary endpoints, such as a statistically significant improvement in liver fibrosis. It is expected that full data will be presented in the next few months.

Dr Arun Sanyal MD, professor of medicine, physiology and molecular pathology at Virginia Commonwealth University School of Medicine, US, and principal investigator on the trial, commented: “I am thrilled to see these statistically significant results from the phase 2 trial of survodutide in MASH and fibrosis. These data position survodutide as a potential leading treatment for a population with great unmet medical needs, and will bring hope to people living with MASH and with fibrosis. I am looking forward to sharing further detail on key secondary endpoints, including the percentage of adults who saw an improvement in fibrosis, at a congress in the first half of this year.”

Carinne Brouillon, head of Human Pharma at Boehringer Ingelheim, added: “These MASH results show survodutide has potential to become a best-in-class treatment, and we believe its true differentiator is the action of the glucagon receptor agonism, which works directly on the liver. In order to bring this potential treatment to the more than one billion people affected by interconnected cardiovascular, renal, metabolic diseases, we will move forward as quickly as possible in MASH. We are also progressing with survodutide in other related conditions, having already initiated our phase 3 clinical trial programme for obesity.”