COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-20
Study Completion:2026-01-13
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06675929

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

The Institute for Liver Health II dba Arizona Clinical Trials
Chandler, Arizona, 85225
United States
Southern California Research Center
Coronado, California, 92118
United States
Catalina Research Institute, LLC-Montclair-49051
Montclair, California, 91763
United States
Knowledge Research Center
Orange, California, 92868
United States
Inland Empire Clinical Trials, LLC
Rialto, California, 92377
United States
Peak Gastroenterology Associates-Colorado Springs-67762
Colorado Springs, Colorado, 80907
United States
Evolution Clinical Trials
Miami, Florida, 33122
United States
Blessed Health Care
Miami, Florida, 33174-3245
United States
Progressive Medical Research
Port Orange, Florida, 32127
United States
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203
United States
Houston Research Institute
Houston, Texas, 77079
United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
United States
Pinnacle Clinical Research, LLC
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Boehringer Ingelheim

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-20
Study Completion Date2026-01-13

Study Record Updates

Study Start Date2025-01-20
Study Completion Date2026-01-13

Terms related to this study

Additional Relevant MeSH Terms

  • Compensated Liver Cirrhosis
  • Metabolic Dysfunction Associated Steatohepatitis (MASH)