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BI 3802876 for adults with compensated cirrhosis from 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)

Phase 2 Interventional Boehringer Ingelheim · NCT07325526

This study will test whether BI 3802876 given by IV infusion is tolerated and how different doses are handled in adults with compensated cirrhosis due to MASH.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment30 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations27 sites (Chandler, Arizona and 26 other locations)
Trial IDNCT07325526 on ClinicalTrials.gov

What this trial studies

Adults with compensated MASH-related cirrhosis are randomly assigned across three dose groups and receive either BI 3802876 or a matching placebo, with participants having more than twice the chance of getting the active medicine. The study medicine is administered as intravenous infusions at two visits, and participants attend a total of 12 site visits over about six months. The main focus is on safety, tolerability, and how the body processes (pharmacokinetics of) the different doses. Data collected will guide dosing and further development of BI 3802876 for liver disease.

Who should consider this trial

Good fit: Adults aged 18–75 with confirmed compensated MASH cirrhosis (Child‑Pugh A) documented by biopsy or qualifying imaging/biomarker criteria are the intended participants.

Not a fit: People with prior liver decompensation, non-MASH causes of cirrhosis, or those outside the age range or unable to attend required site visits are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, BI 3802876 could improve markers of liver health and help slow progression in people with compensated cirrhosis from MASH.

How similar studies have performed: This is an early phase 2 tolerability and pharmacokinetic study for a specific compound; similar early-phase approaches for other liver agents have had mixed results and this compound is not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Chandler, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Conditions Liver Cirrhosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.