NCT07325526 · Boehringer Ingelheim
A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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.
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.
Where
- Chandler, Arizona
- Coronado, California
- La Mesa, California
- Los Angeles, California
- Montclair, California
- Colorado Springs, Colorado
- Miami, Florida
- Miami Lakes, Florida
- University Park, Florida
- Columbus, Georgia
- Iowa City, Iowa
- Kansas City, Kansas
And 12 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations