Clinical trial NCT06675929: A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Compensated Liver Cirrhosis
Metabolic Dysfunction Associated Steatohepatitis (MASH)
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-11-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Occurrence of treatment-emergent, drug-related adverse events in the BI 770371 and placebo arms
timeFrame: Up to Week 15
Secondary outcomes:
measure: Occurrence of adverse events (including clinically relevant findings from medical examination, safety laboratory tests, 12-lead ECG, vital signs, and assessment of local tolerability
timeFrame: Up to Week 22
measure: Change from baseline in the fibrosis-related soluble biomarker PRO-C3 after 12 weeks of treatment
timeFrame: Baseline , at Week 12
Other outcomes:
Locations:
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC-Montclair-49051
state: California
city: Orange
country: United States
facility: Knowledge Research Center
state: California
city: Rialto
country: United States
facility: Inland Empire Clinical Trials, LLC
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates-Colorado Springs-67762
state: Colorado
city: Miami
country: United States
facility: Evolution Clinical Trials
state: Florida
city: Miami
country: United States
facility: Blessed Health Care
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas
state: Texas
city: Houston
country: United States
facility: Houston Research Institute
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation at the Texas Liver Institute
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
Study officials:
References: