Zealand Pharma A/S announced that Boehringer Ingelheim has reported 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 2 trial [response difference: 64.8% (CI 51.1% - 78.6%), p-value (p<0.0001)]. 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.

Full data will be presented in the coming months. The double-blind, placebo-controlled Phase 2 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 6.0 mg.