A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
A Phase IIa Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 3802876 in Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)
2 other identifiers
interventional
30
2 countries
27
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2026
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 7, 2026
CompletedFirst Posted
Study publicly available on registry
January 8, 2026
CompletedStudy Start
First participant enrolled
February 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 29, 2027
April 29, 2026
April 1, 2026
1.1 years
January 7, 2026
April 28, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of any Adverse Events (AEs)
up to 134 days
Secondary Outcomes (3)
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
up to 134 days
Maximum measured concentration of the analyte in serum (Cmax)
up to 134 days
Relative change from baseline in N-terminal type III collagen propeptide (PRO-C3) at week 7
at baseline, at week 7
Study Arms (4)
Placebo group
PLACEBO COMPARATORDose group 1
EXPERIMENTALDose group 2
EXPERIMENTALDose group 3
EXPERIMENTALInterventions
Eligibility Criteria
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.
- 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
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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
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
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2026
First Posted
January 8, 2026
Study Start
February 27, 2026
Primary Completion (Estimated)
March 29, 2027
Study Completion (Estimated)
March 29, 2027
Last Updated
April 29, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing