Actively Recruiting
A Phase IIa Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 3802876 in Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Led by Boehringer Ingelheim · Updated on 2026-05-13
30
Participants Needed
27
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well a medicine called BI 3802876 is tolerated in adults who have a liver condition known as compensated cirrhosis caused by Metabolic Dysfunction-Associated Steatohepatitis (MASH). This Phase IIa study is designed to understand how different doses of BI 3802876 are processed by the body. The goal is to develop treatments that may improve liver health for people living with this condition. Participants are randomly assigned to one of three dose groups, with each group receiving either BI 3802876 or a placebo, which looks like the medicine but contains no active ingredient. Participants have more than twice the chance of receiving BI 3802876 than placebo. The study medicine is given through an infusion into a vein. The treatment period involves two doses administered during the study visits. Over about six months, participants will visit the study site 12 times. During these visits, doctors will monitor any health issues and collect blood samples to study how the medicine is handled in the body. The study compares safety, tolerability, and blood levels of the medicine between the different groups to better understand its effects.
CONDITIONS
Brief Title
A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female adults aged 18 to 75 years at screening, meeting legal consent age
- Diagnosis of compensated cirrhosis caused by Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Child-Pugh category A and no prior decompensation
- Cirrhosis confirmed by biopsy within 5 years or during screening, or diagnosis supported by liver stiffness measurements, imaging, or blood markers as specified
- Additional inclusion criteria apply according to study protocol
You will not qualify if you...
- Clinically significant portal hypertension as defined by specific liver stiffness, platelet count, varices, ELF scores, or hepatic venous pressure gradient
- Other liver diseases such as alcoholic liver disease, autoimmune disorders, drug-induced liver injury, Wilson disease, iron overload, or alpha-1-antitrypsin deficiency
- Past or present hepatitis B or C infection based on screening tests
- History of liver transplantation or listed for transplantation
- Suspected or confirmed hepatocellular carcinoma
- Evidence of prior or current liver decompensation events
- Model for End-Stage Liver Disease (MELD) score greater than 12 unless due to therapeutic anticoagulation
- Significant alcohol use exceeding defined limits within one year before screening
- Elevated International Normalized Ratio (INR) above 1.3 without known cause
- Additional exclusion criteria apply according to study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 134 days
Participants receive either BI 3802876 or placebo to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
Regular visits during treatment period
Trial Site Locations
Total: 27 locations
1
Arizona Clinical Trials - Chandler
Chandler, Arizona, United States, 85225
Not Yet Recruiting
2
Southern California Research Center
Coronado, California, United States, 92118
Not Yet Recruiting
3
Velocity Clinical Research, San Diego
La Mesa, California, United States, 91942
Actively Recruiting
4
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, United States, 90027
Not Yet Recruiting
5
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Not Yet Recruiting
6
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States, 80907
Not Yet Recruiting
7
Schiff Center Liver Diseases
Miami, Florida, United States, 33136
Not Yet Recruiting
8
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
Actively Recruiting
9
Covenant Metabolic Specialists, LLC - University Park
University Park, Florida, United States, 34201
Not Yet Recruiting
10
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States, 31904
Not Yet Recruiting
11
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
12
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
13
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
14
Mayo Clinic, Rochester
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
15
Columbia University Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
16
Lucas Research, Inc.
Morehead City, North Carolina, United States, 28557
Not Yet Recruiting
17
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
18
Nashville General Hospital
Nashville, Tennessee, United States, 37209
Not Yet Recruiting
19
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
Not Yet Recruiting
20
Epic Medical Research - Carrollton
Carrollton, Texas, United States, 75006
Not Yet Recruiting
21
The Liver Institute at Methodist Dallas
Dallas, Texas, United States, 75203
Not Yet Recruiting
22
Baylor Scott & White Research Institute
Dallas, Texas, United States, 75246
Not Yet Recruiting
23
Epic Medical Research - Fort Worth
Fort Worth, Texas, United States, 76120
Not Yet Recruiting
24
Houston Methodist Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
25
Pioneer Research Solutions, Inc.
Houston, Texas, United States, 77099
Not Yet Recruiting
26
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
27
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, Canada, T6G 2XB
Not Yet Recruiting
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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