This study is open to adults with a type of confirmed liver condition called compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH). The purpose of this study is to find out how well a study medicine called BI 3802876 is tolerated in people with this condition. The study looks at how different doses of BI 3802876 are handled by the body. BI 3802876 is being developed to improve liver health in people living with this liver condition. Participants are put in 3 different dose groups randomly, which means by chance. Participants within a group get BI 3802876 or placebo. Placebo looks like BI 3802876 but does not contain any medicine. Participants have more than twice the chance of receiving BI 3802876 than placebo. The study medicine is given as an infusion into a vein. Participants are in the study for about half a year. During this time, they visit the study site 12 times. At 2 visits, participants get the study medicine. Doctors collect information on any health problems and take blood samples to check how BI 3802876 is handled by the body. They compare results between the groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
BI 3802876
Placebo
University of Alabama at Birmingham
Birmingham, Alabama, United States
Southern California Research Center
Coronado, California, United States
Orange County Research Center
Lake Forest, California, United States
Pfleger Liver Institute
Los Angeles, California, United States
Catalina Research Institute, LLC - Montclair
Montclair, California, United States
Occurrence of any Adverse Events (AEs)
Time frame: up to 134 days
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 134 days
Maximum measured concentration of the analyte in serum (Cmax)
Time frame: up to 134 days
Relative change from baseline in N-terminal type III collagen propeptide (PRO-C3) at week 7
Time frame: at baseline, at week 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Velocity Clinical Research, San Diego
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
University of Miami
Miami, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Piedmont Healthcare-Atlanta
Atlanta, Georgia, United States
...and 16 more locations