BI 3802876 for Liver Cirrhosis
What You Need to Know Before You Apply
What is the purpose of this trial?
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. The study looks at how different doses of BI 3802876 are handled by the body. BI 3802876 is being developed to improve liver health in people living with this liver condition.
Participants are put in 3 different dose groups randomly, which means by chance. Participants within a group get BI 3802876 or placebo. Placebo looks like BI 3802876 but does not contain any medicine. Participants have more than twice the chance of receiving BI 3802876 than placebo. The study medicine is given as an infusion into a vein.
Participants are in the study for about half a year. During this time, they visit the study site 12 times. At 2 visits, participants get the study medicine. Doctors collect information on any health problems and take blood samples to check how BI 3802876 is handled by the body. They compare results between the groups.
Are You a Good Fit for This Trial?
Adults aged 18-75 with compensated liver cirrhosis due to MASH are eligible for this trial. They must have specific test results indicating advanced liver fibrosis or cirrhosis, and a biopsy confirming the condition within the last 5 years. Those in Child-Pugh category A without previous decompensation events can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BI 3802876 or placebo as an infusion into a vein. Participants are in the study for about half a year, visiting the study site 12 times, with 2 visits for receiving the study medicine.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with doctors collecting information on health problems and blood samples.
What Are the Treatments Tested in This Trial?
Interventions
- BI 3802876
Trial Overview
The study tests how well people tolerate BI 3802876, a new medication aimed at improving liver health in MASH patients. Participants receive either different doses of BI 3802876 or a placebo via infusion and are monitored over six months through visits and blood samples.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor
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