Testing the tolerance of BI 770371 in patients with cirrhosis from 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 testing how well people with liver cirrhosis from a specific liver condition can tolerate a new medication called BI 770371 compared to a placebo over 12 weeks.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (industry)
• Locations: 12 sites (Coronado, California and 11 other locations)
• Trial ID: NCT06675929 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates how well the medication BI 770371 is tolerated by individuals suffering from compensated liver cirrhosis due to metabolic dysfunction-associated steatohepatitis (MASH). Participants are randomly assigned to receive either BI 770371 or a placebo infusion every three weeks for a total of 12 weeks. Throughout the study, participants will undergo regular health assessments and monitoring to gather data on any adverse effects. The trial aims to compare the health outcomes between the two groups to determine the safety profile of the medication.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with compensated liver cirrhosis due to MASH.

Not a fit: Patients with decompensated liver cirrhosis or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with cirrhosis caused by MASH.

How similar studies have performed: While this approach is being tested in this specific context, similar studies have shown promise in evaluating new treatments for liver diseases.

Eligibility criteria

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

Where this trial is running

Coronado, California and 11 other locations

• Southern California Research Center — Coronado, California, United States (RECRUITING)
• Catalina Research Institute, LLC-Montclair-49051 — Montclair, California, United States (RECRUITING)
• Knowledge Research Center — Orange, California, United States (NOT_YET_RECRUITING)
• Inland Empire Clinical Trials, LLC — Rialto, California, United States (RECRUITING)
• Peak Gastroenterology Associates-Colorado Springs-67762 — Colorado Springs, Colorado, United States (RECRUITING)
• Evolution Clinical Trials — Miami, Florida, United States (RECRUITING)
• Blessed Health Care — Miami, Florida, United States (NOT_YET_RECRUITING)
• Progressive Medical Research — Port Orange, Florida, United States (NOT_YET_RECRUITING)
• The Liver Institute at Methodist Dallas — Dallas, Texas, United States (RECRUITING)
• Houston Research Institute — Houston, Texas, United States (NOT_YET_RECRUITING)
• American Research Corporation at the Texas Liver Institute — San Antonio, Texas, United States (RECRUITING)
• Pinnacle Clinical Research — San Antonio, Texas, United States (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions: Compensated Liver Cirrhosis, Metabolic Dysfunction Associated Steatohepatitis