RecruitingPhase 2NCT07325526

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


Sponsor

Boehringer Ingelheim

Enrollment

29 participants

Start Date

Feb 27, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called BI 3802876 and a drug called Placebo for people with liver cirrhosis. The study is currently recruiting participants at 27 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBI 3802876

BI 3802876

DRUGPlacebo

Placebo


Locations(27)

Arizona Clinical Trials - Chandler

Chandler, Arizona, United States

Southern California Research Center

Coronado, California, United States

Velocity Clinical Research, San Diego

La Mesa, California, United States

Kaiser Permanente - Los Angeles Medical Center

Los Angeles, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States

Schiff Center Liver Diseases

Miami, Florida, United States

Panax Clinical Research

Miami Lakes, Florida, United States

Covenant Metabolic Specialists, LLC - University Park

University Park, Florida, United States

Centricity Research Columbus Georgia Multispecialty

Columbus, Georgia, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Mayo Clinic, Rochester

Rochester, Minnesota, United States

Columbia University Medical Center

New York, New York, United States

Lucas Research, Inc.

Morehead City, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Nashville General Hospital

Nashville, Tennessee, United States

Texas Clinical Research Institute, LLC

Arlington, Texas, United States

Epic Medical Research - Carrollton

Carrollton, Texas, United States

The Liver Institute at Methodist Dallas

Dallas, Texas, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

Epic Medical Research - Fort Worth

Fort Worth, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Pioneer Research Solutions, Inc.

Houston, Texas, United States

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, United States

University of Alberta Hospital (University of Alberta)

Edmonton, Alberta, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07325526


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