A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Male or female adults ≥18 to ≤75 years of age at the time of screening, and at least the legal age of consent in countries where it is \> 18 years
* Patients meeting criteria for Child-Pugh category A without history of previous decompensation event
* Compensated Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis diagnosed by 1 of the following:
* The most recent liver biopsy (≤ 5 years prior to randomisation) showing cirrhosis with steatohepatitis. There is no evidence for a competing aetiology.
* Historical biopsy (≤ 5 years prior to randomisation) showed steatohepatitis with F1 to F3 fibrosis, but now with cirrhosis either by NITs or biopsy. There is no evidence of competing aetiology. If there is a current biopsy (≤ 6 months prior to randomisation), and it does not show evidence of steatosis or steatohepatitis, there is at least 1 coexisting or history of metabolic comorbidity.
* The most recent liver biopsy (≤ 5 years prior to randomisation) showing cirrhosis with steatosis. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and/or type 2 diabetes mellitus (T2DM). There is no evidence for a competing aetiology.
* Historical biopsy (≤ 5 years prior to randomisation) showed steatosis, but now with cirrhosis, either by NITs or biopsy. If there is a current biopsy (≤ 6 months prior to randomisation), and it does not show evidence of steatosis or steatohepatitis, there are at least 2 coexisting or history of metabolic comorbidities including obesity and/or T2DM. There is no evidence of competing aetiology.
* Trial participant with cirrhosis with current or previous imaging showing evidence of steatosis (by liver ultrasound or CT scan or FibroScan® with CAP ≥288 dB/m or MRI-PDFF ≥5%). There is no liver histology available. There are at least 2 coexisting or history of metabolic comorbidities, including obesity and/or T2DM. There is no evidence of competing aetiology.
* Cryptogenic cirrhosis' (either by NITs or biopsy; not to exceed 20% of trial participants) without current or previous evidence of steatosis by imaging or steatosis/steatohepatitis by histology. There are at least 2 coexisting or history of metabolic comorbidities, including obesity and/or T2DM. There is no evidence of competing aetiology.
Further inclusion criteria apply.
Exclusion Criteria:
* Patients with clinically significant signs of advanced portal hypertension defined by any of the following:
* VCTE ≥30 kPa
* VCTE ≥25 kPa if the platelets are ≥150,000/μL
* History of esophageal or gastric varices (Grade ≥1) on endoscopy
* Hepatic venous pressure gradient (HVPG) ≥10 mmHg
* Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis \[PBC\], primary sclerosing cholangitis \[PSC\], autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1- antitryspin deficiency
* Chronic viral hepatitis parameters that would be considered exclusionary for the participation in this trial are (hepatitis B and C testing will be done at screening visit):
* Hepatitis B virus (HBV): Past or present hepatitis B infection, including a positive hepatitis B surface antigen (HBsAg) and/or detectable HBV Deoxyribonucleic Acid (DNA).
* Hepatitis C virus (HCV): Past or present hepatitis C infection, including positive hepatitis C antibodies and/or detectable HCV ribonucleic acid (RNA).
* History of liver transplantation or patients listed for liver transplantation
* Suspicion, confirmed diagnosis, or history of Hepatocellular Carcinoma (HCC)
* Present or past evidence of decompensating events of liver cirrhosis
* Model for End-Stage Liver Disease (MELD) score \> 12, unless due to therapeutic anti-coagulation
* History of significant alcohol consumption (defined as intake of \> 210 g/week in males and \> 140 g/week in females on average over a consecutive period of more than 3 months) within 1 year prior to screening
* International Normalized Ratio (INR) \>1.3 unless due to therapeutic anticoagulants or laboratory error Further exclusion criteria apply.
Primary outcome measure(s)
Occurrence of any Adverse Events (AEs) — up to 134 days
Trial sites (27)
Facility
City
Region
Status
Arizona Clinical Trials - Chandler
Chandler
Arizona
Not Yet Recruiting
Southern California Research Center
Coronado
California
Recruiting
Velocity Clinical Research, San Diego
La Mesa
California
Not Yet Recruiting
Kaiser Permanente - Los Angeles Medical Center
Los Angeles
California
Not Yet Recruiting
Catalina Research Institute, LLC
Montclair
California
Recruiting
Peak Gastroenterology Associates
Colorado Springs
Colorado
Recruiting
Schiff Center Liver Diseases
Miami
Florida
Not Yet Recruiting
Panax Clinical Research
Miami Lakes
Florida
Recruiting
Covenant Metabolic Specialists, LLC - University Park
University Park
Florida
Recruiting
Centricity Research Columbus Georgia Multispecialty
Columbus
Georgia
Recruiting
University of Iowa Hospitals and Clinics
Iowa City
Iowa
Not Yet Recruiting
University of Kansas Medical Center
Kansas City
Kansas
Not Yet Recruiting
Johns Hopkins Hospital
Baltimore
Maryland
Not Yet Recruiting
Mayo Clinic, Rochester
Rochester
Minnesota
Not Yet Recruiting
Columbia University Medical Center
New York
New York
Not Yet Recruiting
Lucas Research, Inc.
Morehead City
North Carolina
Recruiting
Medical University of South Carolina
Charleston
South Carolina
Recruiting
Nashville General Hospital
Nashville
Tennessee
Recruiting
Texas Clinical Research Institute, LLC
Arlington
Texas
Not Yet Recruiting
Epic Medical Research - Carrollton
Carrollton
Texas
Recruiting
The Liver Institute at Methodist Dallas
Dallas
Texas
Not Yet Recruiting
Baylor Scott & White Research Institute
Dallas
Texas
Not Yet Recruiting
Epic Medical Research - Fort Worth
Fort Worth
Texas
Recruiting
Houston Methodist Hospital
Houston
Texas
Not Yet Recruiting
Pioneer Research Solutions, Inc.
Houston
Texas
Recruiting
American Research Corporation at the Texas Liver Institute
San Antonio
Texas
Recruiting
University of Alberta Hospital (University of Alberta)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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