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NCT07325526PHASE2Recruiting

A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)

Boehringer Ingelheim

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

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: * Biopsy (collected during screening or ≤ 5 years\* prior to screening) showing cirrhosis (fibrosis stage 4) with steatosis or steatohepatitis. * Biopsy (collected during screening or ≤ 5 years\* prior to screening) showing cryptogenic cirrhosis. * Biopsy showing steatosis or steatohepatitis prior to screening without confirmation of fibrosis stage 4, or current or previous imaging showing steatosis with no liver histology available must meet either one of the following inclusion criteria at screening: 1. Vibration-controlled transient elastography (VCTE) ≥ 15 kilopascals (kPa) plus 1 of the following, Magnetic Resonance Enterography (MRE) ≥4.2 kPa, platelet count \<150,000/μL or imaging techniques (computed tomography (CT) scan and/or Magnetic Resonance Imaging (MRI) and/or Ultrasound) suggestive of cirrhosis. 2. VCTE measurement ≥ 20 kPa 3. Enhanced Liver Fibrosis (ELF) score ≥ 10.2 \*If biopsy was collected \> 365 days prior to screening either criteria a, b or c must be met Further inclusion criteria apply. Exclusion Criteria : * Patients with clinically significant portal hypertension defined by any of the following: * VCTE ≥25 kPa if the platelets are ≥150,000/μL * VCTE ≥20 kPa if platelets are \<150,000/μL * History of esophageal or gastric varices (Grade ≥1) on endoscopy * ELF score ≥11.3 * 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.

Interventions

DRUG

BI 3802876

DRUG

Placebo

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Conditions

Liver Cirrhosis

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