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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Liver Cirrhosis

In brief

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.

Key facts

Study ID

NCT07325526

Run by

Boehringer Ingelheim

People needed

29

Starts

2026-02-27

Expected to finish

2027-08-05

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.
• VCTE measurement ≥ 20 kPa
• 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.

You may not qualify if…

• 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.

Where it is running

• Covenant Metabolic Specialists, LLC - University Park — University Park, Florida, United States (enrolling)
• Lucas Research, Inc. — Morehead City, North Carolina, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• Nashville General Hospital — Nashville, Tennessee, United States (enrolling)
• Centricity Research Columbus Georgia Multispecialty — Columbus, Georgia, United States (enrolling)
• Epic Medical Research - Carrollton — Carrollton, Texas, United States (enrolling)
• Catalina Research Institute, LLC — Montclair, California, United States (enrolling)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
• Epic Medical Research - Fort Worth — Fort Worth, Texas, United States (enrolling)
• Southern California Research Center — Coronado, California, United States (enrolling)
• Pioneer Research Solutions, Inc. — Houston, Texas, United States (enrolling)
• American Research Corporation at the Texas Liver Institute — San Antonio, Texas, United States (enrolling)
• Panax Clinical Research — Miami Lakes, Florida, United States (enrolling)
• Arizona Clinical Trials - Chandler — Chandler, Arizona, United States
• University of Alberta Hospital (University of Alberta) — Edmonton, Alberta, Canada
• Velocity Clinical Research, San Diego — La Mesa, California, United States
• Kaiser Permanente - Los Angeles Medical Center — Los Angeles, California, United States
• Schiff Center Liver Diseases — Miami, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins Hospital — Baltimore, Maryland, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• Texas Clinical Research Institute, LLC — Arlington, Texas, United States
• The Liver Institute at Methodist Dallas — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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