Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07325526

A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver 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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta Hospital (University of Alberta), Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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
  • 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.

Treatment and study plan

BI 3802876

Drug

BI 3802876

Placebo

Drug

Placebo

Primary outcomes

  1. Occurrence of any Adverse Events (AEs)

    Time frame: up to 134 days

Secondary outcomes

  1. 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

  2. Maximum measured concentration of the analyte in serum (Cmax)

    Time frame: up to 134 days

  3. Relative change from baseline in N-terminal type III collagen propeptide (PRO-C3) at week 7

    Time frame: at baseline, at week 7

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 8, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.