Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo group
  • Drug: Placebo
    Placebo
Experimental
Dose group 1
  • Drug: BI 3802876
    BI 3802876
Experimental
Dose group 2
  • Drug: BI 3802876
    BI 3802876
Experimental
Dose group 3
  • Drug: BI 3802876
    BI 3802876

Recruiting Locations

Velocity Clinical Research, San Diego
La Mesa, California 91942
Contact:
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

Panax Clinical Research
Miami Lakes, Florida 33014
Contact:
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

American Research Corporation at the Texas Liver Institute
San Antonio, Texas 78215
Contact:
Boehringer Ingelheim
833-602-2368
unitedstates@bitrialsupport.com

More Details

Status
Recruiting
Sponsor
Boehringer Ingelheim

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.