Phase 1 Trial to Evaluate Safety and Effects of Single and Multiple Doses of BI 3804379 in Healthy Adults and Patients with Advanced Liver Fibrosis from Metabolic Dysfunction-associated Steatohepatitis MASH

What this Trial Is About

Researchers are evaluating the safety, tolerability, and pharmacokinetics of BI 3804379 in healthy men and women as well as in patients with advanced liver fibrosis caused by metabolic dysfunction-associated steatohepatitis MASH. This Phase 1 study involves both single rising doses and multiple rising doses to better understand how the drug behaves in the body and its safety profile across different participant groups. The trial includes three parts Part A tests single rising doses of BI 3804379 or matching placebo, Part B tests multiple rising doses, and Part C evaluates multiple rising doses in patients with MASH-related advanced liver fibrosis or matching placebo. Participants receive these subcutaneous doses in a randomized, single-blind manner. The study measures drug concentration levels in the blood and monitors for any treatment-emergent adverse events. Participants will undergo health assessments including medical history, physical exams, vital signs, ECGs, and lab tests before and during the study. The team tracks safety events up to 84 days for single doses and up to 235 days for multiple doses. Pharmacokinetic measures such as the area under the concentration-time curve and maximum serum concentration are also recorded. This study is expected to run until March 2028, with ongoing monitoring to understand the drugs effects and safety in both healthy individuals and those with MASH.

A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People and Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH)