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

NCT06675929 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-03

No results posted yet for this study

Summary

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)

Interventions

DRUG

BI 770371

BI 770371

DRUG

Placebo for BI 770371

Placebo for BI 770371

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2026-01-13
Completion
2026-01-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06675929 on ClinicalTrials.gov