A Phase 2 interventional study of BI 3802876 and Placebo in Liver Cirrhosis, sponsored by Boehringer Ingelheim. Recruiting at 28 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Boehringer Ingelheim · Phase 2, Interventional, and Treatment
Among 231 studies in Liver Cirrhosis with a site in United States — 45 open to participants now, 63 under way, 3 of them phase 3. Liver Cirrhosis · United States.
Among the 231 studies in Liver Cirrhosis with a site in United States, this one is the 108th largest by planned enrollment of the 166 interventional ones that give a count, is one of 9 that started in 2026, is one of 58 in phase 2, reaches primary completion later than 30 of the 62 other live ones, and was the 224th registered.
1,300 studies on the registry are indexed under Liver Cirrhosis; 341 are open to participants now.
Browse Liver Cirrhosis studies →45 of the 231 studies in Liver Cirrhosis with a site in United States are open now. Recruiting first, the newest first:
Regeneron Pharmaceuticals · Sites in United States
Ages 18–75
Regeneron Pharmaceuticals · Sites in United States, Puerto Rico, United Kingdom
Ages 18–75
AstraZeneca · Sites in United States, Puerto Rico
Ages 18+
Duke University · Sites in United States
Ages 18+
Olympus Corporation of the Americas · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 209 Liver Cirrhosis studies recruiting now, 101 (48%) set no upper age limit and 67 (32%) stop at 75 or younger; 12 take children under 18; 25 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
231 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 31 · Phase 2 63 · Phase 3 15 · Phase 4 14
First in 1993; this study’s year is marked. 9 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 30 is below the median of 78 across 741 interventional studies indexed under Liver Cirrhosis.
Median enrollment 55 across the 166 interventional studies, 109 across the 63 observational. Of the 150 that completed or were terminated, 63 (42%) have results posted.
This tab as a report to print or save as PDF → With an account.
85 of 231 have an industry lead sponsor. The 10 most frequent:
Boehringer Ingelheim is the lead sponsor of 2,304 studies on the registry; 61 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 123 (73%) have results posted.
Boehringer Ingelheim has 8 studies filed under Liver Cirrhosis — fewer than ten, so there is no comparison to draw.
24 of the studies in Liver Cirrhosis with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05500222Phase 3Madrigal Pharmaceuticals, Inc.A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES) | 2026-12 |
| NCT04592744University of California, Los AngelesAngiotensin 2 for AKI After OLT | 2026-12 |
| NCT03973372University of Texas Southwestern Medical CenterALTA TIPS: A 5-year Longitudinal Observational Study of Patients Undergoing TIPS Placement | 2026-12 |
| NCT05998330Massachusetts General HospitalLiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease | 2026-12-01 |
| NCT04820036Brigham and Women's HospitalA Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG) | 2026-12-24 |
Add all 24 to your calendar (.ics) → With an account.
Among the 231 studies in Liver Cirrhosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
The criteria were revised on the registry on Nov 12, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Compensated Metabolic Dysfunction-Associated Steatohepatitis (MASH) cirrhosis diagnosed by 1 of the following:
Further inclusion criteria apply.
Exclusion Criteria:
Patients with signs of advanced portal hypertension defined by any of the following:
Chronic viral hepatitis parameters that would be considered exclusionary for the participation in this trial are ( and C testing will be done at screening visit):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Placebo
Drug: BI 3802876
Drug: BI 3802876
Drug: BI 3802876
BI 3802876
Placebo
Occurrence of any Adverse Events (AEs)
Time frame: up to 134 days
Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame: up to 134 days
Maximum measured concentration of the analyte in serum (Cmax)
Time frame: up to 134 days
Relative change from baseline in N-terminal type III collagen propeptide (PRO-C3) at week 7
Time frame: at baseline, at week 7
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases(in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Started Feb 2026 (actual). Primary completion is estimated for Aug 2027, 17 months after the start.
Of 28 industry-sponsored phase 2 interventional studies under Liver Cirrhosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 27. This study's planned 17 months is below that.
Counting every sponsor, half of 55 studies reached it within 27 months; a quarter within 19 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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