A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)

Conditions

• Liver Cirrhosis

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• BI 3802876 — DRUG
  BI 3802876
• Placebo — DRUG
  Placebo

Study Details

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.

Key Dates

Start date

Feb 27, 2026

Status verified

Jun 2026

Primary completion

Jun 29, 2027

Completion

Jul 2, 2027

Study Design

Enrollment

29 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo group
• Experimental: Dose group 1
• Experimental: Dose group 2
• Experimental: Dose group 3

Primary Outcome Measure

Occurrence of any Adverse Events (AEs) [ Time Frame: up to 134 days ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (26)

Find similar trials in Chandler, AZ

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