Boehringer Ingelheim announced that up to 83.0% of adults treated with survodutide (BI 456906) achieved a statistically significant improvement of metabolic dysfunction-associated steatohepatitis (MASH) versus placebo (18.2%) in a Phase II trial. The trial met its primary endpoint with survodutide reaching a biopsy-proven improvement in MASH after 48 weeks, without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring). Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. 
 
Survodutide is a glucagon/GLP-1 receptor dual agonist with a novel mechanism of action, and the first to show this level of benefit in a Phase II MASH trial. The glucagon agonist component in survodutide has the potential to increase energy expenditure, and has a direct impact in the liver which potentially contributes to the improvement of fibrosis. The GLP-1 agonist component decreases appetite while increasing fullness and satiety.

The double-blind, placebo-controlled Phase II trial studied three doses of survodutide at 2.4 mg, 4.8 mg, and 6.0 mg. Top-line results demonstrated an improvement in MASH, at all doses explored in the trial. Treatment with survodutide did not show unexpected safety or tolerability issues, including at the higher dose of 6.0mg.
 
The U.S. FDA granted Fast Track Designation for survodutide in 2021, followed by the European Medicines Agency (EMA) granting access for survodutide to the Priority Medicine (PRIME) Scheme for MASH with fibrosis in November last year. 
 
Survodutide is also being evaluated in five Phase III studies for people living with overweight and obesity, among key sub-populations.