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

NCT06675929 | Completed Phase 2 FDA Drug

• 2 other identifiers: 1501-0004U1111-1307-2105
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 13

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.

Conditions

Compensated Liver Cirrhosis; Metabolic Dysfunction Associated Steatohepatitis (MASH)

Outcome Measures

Primary Outcomes (1)

• Occurrence of treatment-emergent, drug-related adverse events in the BI 770371 and placebo arms

  Up to Week 15

Secondary Outcomes (2)

• 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

Study Arms (2)

BI 770371

EXPERIMENTAL

Drug: BI 770371

Placebo for BI 770371

PLACEBO COMPARATOR

Drug: Placebo for BI 770371

Interventions

BI 770371 DRUG

BI 770371

BI 770371

Placebo for BI 770371 DRUG

Placebo for BI 770371

Placebo for BI 770371

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (13)

The Institute for Liver Health II dba Arizona Clinical Trials

Chandler, Arizona, 85225, United States

Location

Southern California Research Center

Coronado, California, 92118, United States

Location

Catalina Research Institute, LLC-Montclair-49051

Montclair, California, 91763, United States

Location

Knowledge Research Center

Orange, California, 92868, United States

Location

Inland Empire Clinical Trials, LLC

Rialto, California, 92377, United States

Location

Peak Gastroenterology Associates-Colorado Springs-67762

Colorado Springs, Colorado, 80907, United States

Location

Evolution Clinical Trials

Miami, Florida, 33122, United States

Location

Blessed Health Care

Miami, Florida, 33174-3245, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

The Liver Institute at Methodist Dallas

Dallas, Texas, 75203, United States

Location

Houston Research Institute

Houston, Texas, 77079, United States

Location

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Pinnacle Clinical Research, LLC

San Antonio, Texas, 78229, United States

Location

Related Links

• Related Info

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: January 20, 2025
• Primary Completion: January 13, 2026
• Study Completion: January 13, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

US (13)