RecruitingLiver Cirrhosis

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

14 states

Healthy volunteers

See if you qualify for this study

Answer a few quick questions about your location and health. Takes about a minute.

Check my eligibility →

About this study

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.

Sponsor: Boehringer Ingelheim

You may qualify 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.
✓ 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 following inclusion criteria at screening:
✓ 1. 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 (CT) scan and/or Magnetic Resonance Imaging (MRI) and/or Ultrasound) suggestive of cirrhosis.
✓ 2. VCTE measurement ≥ 20 kPa

You may not qualify 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
✕ 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 \[PBC\], primary sclerosing cholangitis \[PSC\], autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1- antitryspin deficiency
✕ 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):