A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
Start Date
2/27/2026
Completion Date
8/5/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to 75 years
Interventions
BI 3802876
Placebo
Conditions
Locations
Arizona Clinical Trials - Chandler
Chandler, Arizona 85225
United States
Southern California Research Center
Coronado, California 92118
United States
Velocity Clinical Research, San Diego
La Mesa, California 91942
United States
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California 90027
United States
Catalina Research Institute, LLC
Montclair, California 91763
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
United States
Schiff Center Liver Diseases
Miami, Florida 33136
United States
Panax Clinical Research
Miami Lakes, Florida 33014
United States
Covenant Metabolic Specialists, LLC - University Park
University Park, Florida 34201
United States
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia 31904
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Mayo Clinic, Rochester
Rochester, Minnesota 55905
United States
Columbia University Medical Center
New York, New York 10032
United States
Lucas Research, Inc.
Morehead City, North Carolina 28557
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Nashville General Hospital
Nashville, Tennessee 37209
United States
Texas Clinical Research Institute, LLC
Arlington, Texas 76012
United States
Epic Medical Research - Carrollton
Carrollton, Texas 75006
United States
The Liver Institute at Methodist Dallas
Dallas, Texas 75203
United States
Baylor Scott & White Research Institute
Dallas, Texas 75246
United States
Epic Medical Research - Fort Worth
Fort Worth, Texas 76120
United States
Houston Methodist Hospital
Houston, Texas 77030
United States
Pioneer Research Solutions, Inc.
Houston, Texas 77099
United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas 78215
United States
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta T6G 2XB
Canada