This study is open to people with cirrhosis caused by a liver disease called MASH (metabolic dysfunction-associated steatohepatitis). The purpose of this study is to find out how well a medicine called BI 770371 is tolerated. Participants are put into 2 groups by chance. One group gets BI 770371 as an infusion into a vein and the other group gets placebo as an infusion into a vein. Placebo infusions look like BI 770371 infusions but do not contain any medicine. Participants get an infusion every 3 weeks for 12 weeks. Participants are in the study for about 5 months. During this time, they visit the study site 16 times. This also includes 1 overnight stay at the study site. The doctors regularly check participants' health and collect information on any health problems of the participants. The results are compared between the 2 groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
28
BI 770371
Placebo for BI 770371
The Institute for Liver Health II dba Arizona Clinical Trials
Chandler, Arizona, United States
Southern California Research Center
Coronado, California, United States
Catalina Research Institute, LLC-Montclair-49051
Montclair, California, United States
Knowledge Research Center
Orange, California, United States
Inland Empire Clinical Trials, LLC
Rialto, California, United States
Peak Gastroenterology Associates-Colorado Springs-67762
Colorado Springs, Colorado, United States
Evolution Clinical Trials
Miami, Florida, United States
Blessed Health Care
Miami, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
The Liver Institute at Methodist Dallas
Dallas, Texas, United States
...and 3 more locations
Occurrence of treatment-emergent, drug-related adverse events in the BI 770371 and placebo arms
Time frame: Up to Week 15
Occurrence of adverse events (including clinically relevant findings from medical examination, safety laboratory tests, 12-lead ECG, vital signs, and assessment of local tolerability
Time frame: Up to Week 22
Change from baseline in the fibrosis-related soluble biomarker PRO-C3 after 12 weeks of treatment
PRO = propeptide
Time frame: Baseline , at Week 12
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