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

Completed · Phase 2 · Has a placebo group

Conditions studied: Compensated Liver Cirrhosis, Metabolic Dysfunction Associated Steatohepatitis (MASH)

In brief

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.

Key facts

Study ID

NCT06675929

Run by

Boehringer Ingelheim

People needed

28

Starts

2025-01-20

Expected to finish

2026-01-13

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥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

You may not qualify if…

• 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

Where it is running

• The Institute for Liver Health II dba Arizona Clinical Trials — Chandler, Arizona, 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
• Blessed Health Care — 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, LLC — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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