BI 3802876 for Liver Cirrhosis

Not yet recruiting at 25 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Boehringer Ingelheim
Prior Safety DataThis treatment has passed at least one previous human trial

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

My biopsy within the last 5 years shows cryptogenic cirrhosis.
My liver functions well despite my liver disease.
My tests show liver stiffness and possible cirrhosis.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

24 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with doctors collecting information on health problems and blood samples.

4 weeks

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

Group I: Dose group 3Experimental Treatment1 Intervention
Group II: Dose group 2Experimental Treatment1 Intervention
Group III: Dose group 1Experimental Treatment1 Intervention
Group IV: Placebo groupPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials
2,566
Recruited
16,150,000+