Liver CirrhosisPhase 2NCT07325526

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

A Phase 2 study testing BI 3802876 in people with Liver Cirrhosis, run by Boehringer Ingelheim at 27 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Liver Cirrhosis
What is being tested?: BI 3802876
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 27 sitesin 2 countries
Study dates: 27 Feb 2026to 5 Aug 2027
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
The most recent liver biopsy (≤ 5 years prior to randomisation) showing cirrhosis with steatohepatitis. There is no evidence for a competing aetiology.
Historical biopsy (≤ 5 years prior to randomisation) showed steatohepatitis with F1 to F3 fibrosis, but now with cirrhosis either by NITs or biopsy. There is no evidence of competing aetiology. If there is a current biopsy (≤ 6 months prior to randomisation), and it does not show evidence of steatosis or steatohepatitis, there is at least 1 coexisting or history of metabolic comorbidity.
The most recent liver biopsy (≤ 5 years prior to randomisation) showing cirrhosis with steatosis. There are at least 2 coexisting metabolic comorbidities or history of metabolic comorbidities, including obesity and/or type 2 diabetes mellitus (T2DM). There is no evidence for a competing aetiology.

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Historical biopsy (≤ 5 years prior to randomisation) showed steatosis, but now with cirrhosis, either by NITs or biopsy. If there is a current biopsy (≤ 6 months prior to randomisation), and it does not show evidence of steatosis or steatohepatitis, there are at least 2 coexisting or history of metabolic comorbidities including obesity and/or T2DM. There is no evidence of competing aetiology.
Trial participant with cirrhosis with current or previous imaging showing evidence of steatosis (by liver ultrasound or CT scan or FibroScan® with CAP ≥288 dB/m or MRI-PDFF ≥5%). There is no liver histology available. There are at least 2 coexisting or history of metabolic comorbidities, including obesity and/or T2DM. There is no evidence of competing aetiology.
Cryptogenic cirrhosis' (either by NITs or biopsy; not to exceed 20% of trial participants) without current or previous evidence of steatosis by imaging or steatosis/steatohepatitis by histology. There are at least 2 coexisting or history of metabolic comorbidities, including obesity and/or T2DM. There is no evidence of competing aetiology.
Further inclusion criteria apply.

Who cannot join

Patients with clinically significant signs of advanced portal hypertension defined by any of the following:
VCTE ≥30 kPa
VCTE ≥25 kPa if the platelets are ≥150,000/μL
History of esophageal or gastric varices (Grade ≥1) on endoscopy
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

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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):
Hepatitis B virus (HBV): Past or present hepatitis B infection, including a positive hepatitis B surface antigen (HBsAg) and/or detectable HBV Deoxyribonucleic Acid (DNA).
Hepatitis C virus (HCV): Past or present hepatitis C infection, including positive hepatitis C antibodies and/or detectable HCV ribonucleic acid (RNA).
History of liver transplantation or patients listed for liver transplantation
Suspicion, confirmed diagnosis, or history of Hepatocellular Carcinoma (HCC)
Present or past evidence of decompensating events of liver cirrhosis
Model for End-Stage Liver Disease (MELD) score > 12, unless due to therapeutic anti-coagulation
History of significant alcohol consumption (defined as intake of > 210 g/week in males and > 140 g/week in females on average over a consecutive period of more than 3 months) within 1 year prior to screening
International Normalized Ratio (INR) >1.3 unless due to therapeutic anticoagulants or laboratory error Further exclusion criteria apply.

Trial locations and contacts

27 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Boehringer Ingelheim contact

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Country

City, postcode or hospital

Sites recruiting now only

27 sites in 2 countries

United States26 sites, 26 recruiting

Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Epic Medical Research - Carrollton
Carrollton, Texas, 75006
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Arizona Clinical Trials - Chandler
Chandler, Arizona, 85225
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, 31904
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Southern California Research Center
Coronado, California, 92118
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Baylor Scott & White Research Institute
Dallas, Texas, 75246
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Epic Medical Research - Fort Worth
Fort Worth, Texas, 76120
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Pioneer Research Solutions, Inc.
Houston, Texas, 77099
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Velocity Clinical Research, San Diego
La Mesa, California, 91942
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Kaiser Permanente - Los Angeles Medical Center
Los Angeles, California, 90027
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Not yet recruiting
Schiff Center Liver Diseases
Miami, Florida, 33136
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Panax Clinical Research
Miami Lakes, Florida, 33014
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Catalina Research Institute, LLC
Montclair, California, 91763
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Lucas Research, Inc.
Morehead City, North Carolina, 28557
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Nashville General Hospital
Nashville, Tennessee, 37209
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Columbia University Medical Center
New York, New York, 10032
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting
Covenant Metabolic Specialists, LLC - University Park
University Park, Florida, 34201
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Recruiting

Other trials in United States

Canada1 site, 1 recruiting

University of Alberta Hospital (University of Alberta)
Edmonton, Alberta, T6G 2XB
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Not yet recruiting

Other trials in Canada

About this study

Official title: A Phase IIa Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 3802876 in Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)

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.

Conditions: Liver Cirrhosis
Being tested: BI 3802876, Placebo
Medical subject headings: Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BI 3802876Drug
BI 3802876
PlaceboDrug
Placebo

Study groups in NCT07325526
Study group	Role	What they receive
Placebo group	Placebo comparator	Not described Receives: Drug: Placebo
Dose group 1	Experimental	Not described Receives: Drug: BI 3802876
Dose group 2	Experimental	Not described Receives: Drug: BI 3802876
Dose group 3	Experimental	Not described Receives: Drug: BI 3802876

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of any Adverse Events (AEs)
Measured: up to 134 days

Secondary outcomes (3)

Area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity (AUC0-∞)
Measured: up to 134 days
Maximum measured concentration of the analyte in serum (Cmax)
Measured: up to 134 days
Relative change from baseline in N-terminal type III collagen propeptide (PRO-C3) at week 7
Measured: at baseline, at week 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Feb 20265 Aug 2027

First posted8 Jan 2026
Study start27 Feb 2026
Primary completion5 Aug 2027 (estimated)
Study completion5 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Liver CirrhosisStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07325526
Sponsor's protocol ID: 1517-0002
Other IDs: 1111-1313-8064
Status last verified: Oct 2026
First submitted: 7 Jan 2026
Last updated: 14 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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

Interested in taking part?

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
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RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis

All Liver Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIa Double-blind, Placebo-controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 3802876 in Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatohepatitis (MASH)
ClinicalTrials.gov ID: NCT07325526
Acronym / sponsor ID: 1517-0002
Conditions: Liver Cirrhosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 27 Feb 2026 (actual)
Primary completion: 5 Aug 2027 (estimated)
Study completion: 5 Aug 2027 (estimated)
First posted: 8 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo group	Placebo comparator	Drug: Placebo
Dose group 1	Experimental	Drug: BI 3802876
Dose group 2	Experimental	Drug: BI 3802876
Dose group 3	Experimental	Drug: BI 3802876

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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:
Further inclusion criteria apply.

Key exclusion criteria (15 listed)

Patients with clinically significant signs of advanced portal hypertension defined by any of the following:
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):
History of liver transplantation or patients listed for liver transplantation
Suspicion, confirmed diagnosis, or history of Hepatocellular Carcinoma (HCC)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BI 3802876BI 3802876	Drug	Dose group 1, Dose group 2, Dose group 3
PlaceboPlacebo	Drug	Placebo group

Primary outcome

Occurrence of any Adverse Events (AEs)
Time frame: up to 134 days

3 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: 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

Related trials for Liver Cirrhosis

Not yet recruitingObservational study
A Study of Fatigue, Itching and Daily Activities in People With Primary Biliary Cholangitis Starting Elafibranor
Primary Biliary Cholangitis (PBC)
RecruitingPhase 1/2
Nitazoxanide in Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 3
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
Primary Biliary Cirrhosis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis
RecruitingPhase 2/3
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
Primary Biliary Cholangitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Boehringer Ingelheim contact

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

27 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BI 3802876 in people with Liver Cirrhosis, run by Boehringer Ingelheim at 27 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of any Adverse Events (AEs) (time frame: up to 134 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07325526.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.