A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH

Description

This study is open to people with cirrhosis caused by a liver disease called MASH (metabolic dysfunction-associated steatohepatitis). The purpose of this study is to find out how well a medicine called BI 770371 is tolerated. Participants are put into 2 groups by chance. One group gets BI 770371 as an infusion into a vein and the other group gets placebo as an infusion into a vein. Placebo infusions look like BI 770371 infusions but do not contain any medicine. Participants get an infusion every 3 weeks for 12 weeks. Participants are in the study for about 5 months. During this time, they visit the study site 16 times. This also includes 1 overnight stay at the study site. The doctors regularly check participants' health and collect information on any health problems of the participants. The results are compared between the 2 groups.

Conditions

Compensated Liver Cirrhosis, Metabolic Dysfunction Associated Steatohepatitis (MASH)

Study Overview

Study Details

Study overview

This study is open to people with cirrhosis caused by a liver disease called MASH (metabolic dysfunction-associated steatohepatitis). The purpose of this study is to find out how well a medicine called BI 770371 is tolerated. Participants are put into 2 groups by chance. One group gets BI 770371 as an infusion into a vein and the other group gets placebo as an infusion into a vein. Placebo infusions look like BI 770371 infusions but do not contain any medicine. Participants get an infusion every 3 weeks for 12 weeks. Participants are in the study for about 5 months. During this time, they visit the study site 16 times. This also includes 1 overnight stay at the study site. The doctors regularly check participants' health and collect information on any health problems of the participants. The results are compared between the 2 groups.

Safety, Tolerability and Pharmacodynamics of BI 770371 Administered Intravenously in Patients With Compensated Cirrhosis Due to MASH: a Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled Trial

A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH

Condition
Compensated Liver Cirrhosis
Intervention / Treatment

-

Contacts and Locations

Coronado

Southern California Research Center, Coronado, California, United States, 92118

Montclair

Catalina Research Institute, LLC-Montclair-49051, Montclair, California, United States, 91763

Rialto

Inland Empire Clinical Trials, LLC, Rialto, California, United States, 92377

Colorado Springs

Peak Gastroenterology Associates-Colorado Springs-67762, Colorado Springs, Colorado, United States, 80907

Dallas

The Liver Institute at Methodist Dallas, Dallas, Texas, United States, 75203

Houston

Houston Research Institute, Houston, Texas, United States, 77079

San Antonio

American Research Corporation at the Texas Liver Institute, San Antonio, Texas, United States, 78215

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to 75 Years

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Boehringer Ingelheim,

    Study Record Dates

    2025-12-29