Recruiting
Phase 2

BI 3802876

Sponsor:

Boehringer Ingelheim

Code:

NCT07325526

Conditions

Liver Cirrhosis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

BI 3802876

Placebo

Study Details

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.

Conditions

Liver Cirrhosis

Study ID

NCT07325526

Start date

Feb 27, 2026

Status verified date

Aug, 2026

Completion date

Aug 5, 2027

Anticipated

Primary completion date

Aug 5, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Placebo group

experimental: Dose group 1

experimental: Dose group 2

experimental: Dose group 3

Interventions

BI 3802876

BI 3802876

Placebo

Placebo

Primary outcome measure

  • Occurrence of any Adverse Events (AEs) [ Time Frame: up to 134 days ]

Central Contacts and Locations

Central contacts

Boehringer Ingelheim

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

Locations

Southern California Research Center

Recruiting

Coronado, California, United States, 92118

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Catalina Research Institute, LLC

Recruiting

Montclair, California, United States, 91763

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Peak Gastroenterology Associates

Recruiting

Colorado Springs, Colorado, United States, 80907

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Panax Clinical Research

Recruiting

Miami Lakes, Florida, United States, 33014

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Covenant Metabolic Specialists, LLC - University Park

Recruiting

University Park, Florida, United States, 34201

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Centricity Research Columbus Georgia Multispecialty

Recruiting

Columbus, Georgia, United States, 31904

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Lucas Research, Inc.

Recruiting

Morehead City, North Carolina, United States, 28557

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Nashville General Hospital

Recruiting

Nashville, Tennessee, United States, 37209

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Epic Medical Research - Carrollton

Recruiting

Carrollton, Texas, United States, 75006

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Epic Medical Research - Fort Worth

Recruiting

Fort Worth, Texas, United States, 76120

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

Pioneer Research Solutions, Inc.

Recruiting

Houston, Texas, United States, 77099

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

American Research Corporation at the Texas Liver Institute

Recruiting

San Antonio, Texas, United States, 78215

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-09-01.