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

Phase 2

Recruiting

• Conditions: Compensated Liver Cirrhosis; Metabolic Dysfunction Associated Steatohepatitis (MASH)
• Interventions: Drug: BI 770371; Drug: Placebo for BI 770371

• Registration Number: NCT06675929
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-04
• Study First Submitted QC: 2024-11-04
• Study First Posted: 2024-11-05
• Study Start: 2025-01-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-16
• Primary Completion: 2025-12-29
• Study Completion: 2025-12-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 770371	BI 770371	-
Placebo for BI 770371	Placebo for BI 770371	-

Primary Outcome Measures

Name	Time	Method
Occurrence of treatment-emergent, drug-related adverse events in the BI 770371 and placebo arms	Up to Week 15

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events (including clinically relevant findings from medical examination, safety laboratory tests, 12-lead ECG, vital signs, and assessment of local tolerability	Up to Week 22
Change from baseline in the fibrosis-related soluble biomarker PRO-C3 after 12 weeks of treatment	Baseline , at Week 12	PRO = propeptide

Trial Locations

Locations (12)

Blessed Health Care; 🇺🇸 Miami, Florida, United States

Southern California Research Center; 🇺🇸 Coronado, California, United States

Catalina Research Institute, LLC-Montclair-49051; 🇺🇸 Montclair, California, United States

Knowledge Research Center; 🇺🇸 Orange, California, United States

Inland Empire Clinical Trials, LLC; 🇺🇸 Rialto, California, United States

Peak Gastroenterology Associates-Colorado Springs-67762; 🇺🇸 Colorado Springs, Colorado, United States

Evolution Clinical Trials; 🇺🇸 Miami, Florida, United States

Progressive Medical Research; 🇺🇸 Port Orange, Florida, United States

The Liver Institute at Methodist Dallas; 🇺🇸 Dallas, Texas, United States

Houston Research Institute; 🇺🇸 Houston, Texas, United States

American Research Corporation at the Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States

Pinnacle Clinical Research; 🇺🇸 San Antonio, Texas, United States