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

May 12, 2026 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2XB
        • Not yet recruiting
        • University of Alberta Hospital (University of Alberta)
        • Contact:
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
    • California
      • Coronado, California, United States, 92118
      • La Mesa, California, United States, 91942
      • Los Angeles, California, United States, 90027
        • Not yet recruiting
        • Kaiser Permanente - Los Angeles Medical Center
        • Contact:
      • Montclair, California, United States, 91763
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
    • Florida
      • Miami, Florida, United States, 33136
      • Miami Lakes, Florida, United States, 33014
      • University Park, Florida, United States, 34201
        • Not yet recruiting
        • Covenant Metabolic Specialists, LLC - University Park
        • Contact:
    • Georgia
      • Columbus, Georgia, United States, 31904
        • Not yet recruiting
        • Centricity Research Columbus Georgia Multispecialty
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Minnesota
      • Rochester, Minnesota, United States, 55905
    • New York
      • New York, New York, United States, 10032
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
    • South Carolina
      • Charleston, South Carolina, United States, 29425
    • Tennessee
      • Nashville, Tennessee, United States, 37209
    • Texas
      • Arlington, Texas, United States, 76012
        • Not yet recruiting
        • Texas Clinical Research Institute, LLC
        • Contact:
      • Carrollton, Texas, United States, 75006
      • Dallas, Texas, United States, 75246
        • Not yet recruiting
        • Baylor Scott & White Research Institute
        • Contact:
      • Dallas, Texas, United States, 75203
        • Not yet recruiting
        • The Liver Institute At Methodist Dallas
        • Contact:
      • Fort Worth, Texas, United States, 76120
      • Houston, Texas, United States, 77030
      • Houston, Texas, United States, 77099
      • San Antonio, Texas, United States, 78215
        • Recruiting
        • American Research Corporation at the Texas Liver Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of any Adverse Events (AEs)
Time Frame: up to 134 days
up to 134 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time Frame: up to 134 days
up to 134 days
Maximum measured concentration of the analyte in serum (Cmax)
Time Frame: up to 134 days
up to 134 days
Relative change from baseline in N-terminal type III collagen propeptide (PRO-C3) at week 7
Time Frame: at baseline, at week 7
at baseline, at week 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 27, 2026

Primary Completion (Estimated)

March 29, 2027

Study Completion (Estimated)

March 29, 2027

Study Registration Dates

First Submitted

January 7, 2026

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1517-0002
  • 1111-1313-8064 (Registry Identifier: WHO Registry Identifier)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Cirrhosis

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe