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

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

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.

Study Overview

• Status: Completed
• Conditions: Compensated Liver Cirrhosis; Metabolic Dysfunction Associated Steatohepatitis (MASH)
• Intervention / Treatment: Drug: BI 770371; Drug: Placebo for BI 770371

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• ≥18 to ≤75 years old
• Male or female participants
• Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
• Men able to father a child must be willing to use male contraception (condom or sexual abstinence) consistently and correctly until end of study. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
• Signed and dated written informed consent in accordance with ICH-Good Clinical Practice (GCP) and local legislation prior to admission to the trial
• Patients meeting criteria for Child-Pugh category A

• Adequate organ function or liver laboratory tests defined as all of the following:

  • Total bilirubin ≤1.5 mg/dL. If the total bilirubin is > upper limit of normal (ULN) and a ≤1.5 mg/dL, the direct bilirubin must be <50% of total bilirubin
  • For patients with Gilbert's syndrome: total bilirubin ≤3x ULN or direct bilirubin ≤1.5x ULN
  • Aspartate transaminase (AST) and alanine transaminase (ALT) ≤5x ULN
  • Alkaline Phosphatase <1.5x ULN
  • International Normalized Ratio (INR) ≤1.4
  • Model for End-Stage Liver Disease (MELD) score <12
  • Platelet count ≥110 000/mL
  • Albumin >3.4 g/dl

Exclusion criteria

• Major surgery (major according to the investigator's assessment) performed within 24-weeks prior to randomization, major surgery planned within 6 months after screening (e.g. hip replacement), or bariatric surgery within 2 years prior to randomization
• Any documented active or suspected malignancy or history of malignancy within 5-years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix. Specifically, any patients with suspected, confirmed, or history of hepatocellular carcinoma will be excluded
• Suspected or confirmed portal vein thrombosis within 6 months of enrollment
• History of liver transplantation
• Current listing for liver transplantation
• Present or past evidence of hepatic decompensation, in the opinion of the investigator, including but not limited to variceal hemorrhage, ascites, and/or hepatic encephalopathy

• Patients with clinically significant portal hypertension defined by any one of the following:

  • FibroScan ≥25 Kilo Pascal (kPA) if the platelets are ≥150,000/μL
  • FibroScan ≥20 kPA if platelets are <150,000/μL
  • Evidence of esophageal or gastric varices (≥grade1) on the most recent endoscopy
  • Enhanced liver fibrosis (ELF) ≥11.3
  • Hepatic venous pressure gradient (HVPG) ≥10 mm Hg
• further exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BI 770371	Drug: BI 770371; BI 770371
Placebo Comparator: Placebo for BI 770371	Drug: Placebo for BI 770371; Placebo for BI 770371

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	PRO = propeptide	Baseline , at Week 12

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Actual): January 13, 2026
• Study Completion (Actual): January 13, 2026

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 1501-0004; U1111-1307-2105 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
• IPD Sharing Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• IPD Sharing Access Criteria: For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No