Actively Recruiting
A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
Led by Boehringer Ingelheim · Updated on 2026-05-13
30
Participants Needed
27
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 18 to 75 years
- Diagnosed with compensated Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis, meeting Child-Pugh category A without prior decompensation
- Cirrhosis confirmed by biopsy within 5 years showing fibrosis stage 4 with steatosis or steatohepatitis, or cryptogenic cirrhosis, or meeting specific imaging and laboratory criteria if biopsy is older or unavailable
You will not qualify if you...
- Clinically significant portal hypertension as defined by specific VCTE values with platelet counts, history of esophageal or gastric varices, ELF score above 11.3, or hepatic venous pressure gradient above 10 mmHg
- Other liver diseases such as alcoholic liver disease, autoimmune disorders, drug-induced liver injury, Wilson disease, iron overload, or alpha-1-antitrypsin deficiency
- Past or present hepatitis B or C infection
- History of liver transplantation or being listed for liver transplantation
- Suspicion or diagnosis of Hepatocellular Carcinoma (HCC)
- History or evidence of decompensated liver cirrhosis events
- Model for End-Stage Liver Disease (MELD) score above 12 unless due to anticoagulation
- Significant alcohol intake within 1 year prior to screening exceeding defined limits
- International Normalized Ratio (INR) above 1.3 unless due to therapeutic anticoagulants or laboratory error
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 27 locations
1
Arizona Clinical Trials - Chandler
Chandler, Arizona, United States, 85225
Not Yet Recruiting
2
Southern California Research Center
Coronado, California, United States, 92118
Not Yet Recruiting
3
Velocity Clinical Research, San Diego
La Mesa, California, United States, 91942
Actively Recruiting
4
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States, 90027
Not Yet Recruiting
5
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Not Yet Recruiting
6
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Not Yet Recruiting
7
Schiff Center Liver Diseases
Miami, Florida, United States, 33136
Not Yet Recruiting
8
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
Actively Recruiting
9
Covenant Metabolic Specialists, LLC - University Park
University Park, Florida, United States, 34201
Not Yet Recruiting
10
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States, 31904
Not Yet Recruiting
11
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
12
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
13
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
14
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
15
Columbia University Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
16
Lucas Research, Inc.
Morehead City, North Carolina, United States, 28557
Not Yet Recruiting
17
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
18
Nashville General Hospital
Nashville, Tennessee, United States, 37209
Not Yet Recruiting
19
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
Not Yet Recruiting
20
Epic Medical Research - Carrollton
Carrollton, Texas, United States, 75006
Not Yet Recruiting
21
The Liver Institute at Methodist Dallas
Dallas, Texas, United States, 75203
Not Yet Recruiting
22
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75246
Not Yet Recruiting
23
Epic Medical Research - Fort Worth
Fort Worth, Texas, United States, 76120
Not Yet Recruiting
24
Houston Methodist Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
25
Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77099
Not Yet Recruiting
26
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
27
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada, T6G 2XB
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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