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New treatment option for Liver Cirrhosis
Official title A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
ClinicalTrials.gov ID: NCT07325526
What this study is testing
What is BI 3802876?
BI 3802876 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for liver cirrhosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is open to adults with a type of confirmed liver condition called compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH). The purpose of this study is to find out how well a study medicine called BI 3802876 is tolerated in people with this condition.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male or female adults ≥18 to ≤75 years of age at the time of screening, and at least the legal age of consent in countries where it is \> 18 years
- Patients meeting criteria for Child-Pugh category A without history of previous decompensation event
- Compensated Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis diagnosed by 1 of the following:
- Biopsy (collected during screening or ≤ 5 years\ prior to screening) showing cirrhosis (fibrosis stage 4) with steatosis or steatohepatitis.
- Biopsy (collected during screening or ≤ 5 years\ prior to screening) showing cryptogenic cirrhosis.
You likely can't join if
- Patients with clinically significant portal hypertension defined by any of the following:
- VCTE ≥25 kPa if the platelets are ≥150,000/μL
- VCTE ≥20 kPa if platelets are \<150,000/μL
- History of esophageal or gastric varices (Grade ≥1) on endoscopy
- ELF score ≥11.3
- Hepatic venous pressure gradient (HVPG) ≥10 mmHg
See the full eligibility criteria
- Male or female adults ≥18 to ≤75 years of age at the time of screening, and at least the legal age of consent in countries where it is \> 18 years
- Patients meeting criteria for Child-Pugh category A without history of previous decompensation event
- Compensated Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis diagnosed by 1 of the following:
- Biopsy (collected during screening or ≤ 5 years\ prior to screening) showing cirrhosis (fibrosis stage 4) with steatosis or steatohepatitis.
- Biopsy (collected during screening or ≤ 5 years\ prior to screening) showing cryptogenic cirrhosis.
- Biopsy showing steatosis or steatohepatitis prior to screening without confirmation of fibrosis stage 4, or current or previous imaging showing steatosis with no liver histology available must meet either one of the...
- Vibration-controlled transient elastography (VCTE) ≥ 15 kilopascals (kPa) plus 1 of the following, Magnetic Resonance Enterography (MRE) ≥4.2 kPa, platelet count \<150,000/μL or imaging techniques (computed tomography...
- VCTE measurement ≥ 20 kPa
- Enhanced Liver Fibrosis (ELF) score ≥ 10.2 \ If biopsy was collected \> 365 days prior to screening either criteria a, b or c must be met Further apply.
- Patients with clinically significant portal hypertension defined by any of the following:
- VCTE ≥25 kPa if the platelets are ≥150,000/μL
- VCTE ≥20 kPa if platelets are \<150,000/μL
- History of esophageal or gastric varices (Grade ≥1) on endoscopy
- ELF score ≥11.3
- Hepatic venous pressure gradient (HVPG) ≥10 mmHg
- Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to alcoholic liver disease, autoimmune disorders (e.g., primary biliary cholangitis [PBC]...
- Chronic viral hepatitis parameters that would be considered exclusionary for the participation in this trial are (hepatitis B and C testing will be done at screening visit):
- Hepatitis B virus (HBV): Past or present hepatitis B infection, including a positive hepatitis B surface antigen (HBsAg) and/or detectable HBV Deoxyribonucleic Acid (DNA).
- Hepatitis C virus (HCV): Past or present hepatitis C infection, including positive hepatitis C antibodies and/or detectable HCV ribonucleic acid (RNA).
- History of liver transplantation or patients listed for liver transplantation
- Suspicion, confirmed diagnosis, or history of Hepatocellular Carcinoma (HCC)
- Present or past evidence of decompensating events of liver cirrhosis
- Model for End-Stage Liver Disease (MELD) score \> 12, unless due to therapeutic anti-coagulation
- History of significant alcohol consumption (defined as intake of \> 210 g/week in males and \> 140 g/week in females on average over a consecutive period of more than 3 months) within 1 year prior to screening
- International Normalized Ratio (INR) \>1.3 unless due to therapeutic anticoagulants or laboratory error Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Coronado, California, United States
- La Mesa, California, United States
- Los Angeles, California, United States
- Montclair, California, United States
- Colorado Springs, Colorado, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- University Park, Florida, United States
- Columbus, Georgia, United States
- Iowa City, Iowa, United States
- Kansas City, Kansas, United States
- Baltimore, Maryland, United States
- Rochester, Minnesota, United States
- New York, New York, United States
- Morehead City, North Carolina, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Arlington, Texas, United States
- Carrollton, Texas, United States
+ 5 more site(s).
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Coronado, California, United States; La Mesa, California, United States; Los Angeles, California, United States; Montclair, California, United States; Colorado Springs, Colorado, United States and 19 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.