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NCT07325526 · Boehringer Ingelheim

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

What this study is about

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.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

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.

Where

  • Chandler, Arizona
  • Coronado, California
  • La Mesa, California
  • Los Angeles, California
  • Montclair, California
  • Colorado Springs, Colorado
  • Miami, Florida
  • Miami Lakes, Florida
  • University Park, Florida
  • Columbus, Georgia
  • Iowa City, Iowa
  • Kansas City, Kansas

And 12 more locations — see the full list below.

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 9, 2026 · Source of record for eligibility and locations

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1 of 29 participants interested
3% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

Choose your preferred location, or select flexible during enrollment.

NOT_YET_RECRUITING

Chandler

Arizona

Location available
NOT_YET_RECRUITING

Coronado

California

Location available
NOT_YET_RECRUITING

La Mesa

California

Location available
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Los Angeles

California

Location available
NOT_YET_RECRUITING

Montclair

California

Location available
NOT_YET_RECRUITING

Colorado Springs

Colorado

Location available
NOT_YET_RECRUITING

Miami

Florida

Location available
View Miami location page
NOT_YET_RECRUITING

Miami Lakes

Florida

Location available
NOT_YET_RECRUITING

University Park

Florida

Location available

And 17 more locations available.

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

Find More Liver Disease Trials by City

Browse all liver disease clinical trials in these cities — not just this study.

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Looking for Liver Cirrhosis Treatment in Chandler?

Join others in Arizona exploring innovative treatment options through clinical research

Liver Cirrhosis Treatment Options in Chandler, Arizona

If you're searching for Liver Cirrhosis treatment in Chandler, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Chandler, Coronado, La Mesa and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Liver Cirrhosis. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arizona
Now Enrolling
Up to 29 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Liver Cirrhosis?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Liver Cirrhosis

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Liver Cirrhosis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07325526. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.