Compensated Liver CirrhosisPhase 2NCT06675929
A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH
A Phase 2 study testing BI 770371 in people with Compensated Liver Cirrhosis and Metabolic Dysfunction Associated Steatohepatitis (MASH), run by Boehringer Ingelheim at 13 sites in United States.
Trial summary
This study is open to people with cirrhosis caused by a liver disease called MASH (metabolic dysfunction-associated steatohepatitis). The purpose of this study is to find out how well a medicine called BI 770371 is tolerated. Participants are put into 2 groups by chance. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Compensated Liver Cirrhosis, Metabolic Dysfunction Associated Steatohepatitis (MASH)
- What is being tested?
- BI 770371
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 13 sitesUnited States
- Study dates
- 20 Jan 2025to 13 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- ≥18 to ≤75 years old
- Male or female participants
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
- Men able to father a child must be willing to use male contraception (condom or sexual abstinence) consistently and correctly until end of study. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
- Signed and dated written informed consent in accordance with ICH-Good Clinical Practice (GCP) and local legislation prior to admission to the trial
- Patients meeting criteria for Child-Pugh category A
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- Adequate organ function or liver laboratory tests defined as all of the following:
- Total bilirubin ≤1.5 mg/dL. If the total bilirubin is > upper limit of normal (ULN) and a ≤1.5 mg/dL, the direct bilirubin must be <50% of total bilirubin
- For patients with Gilbert's syndrome: total bilirubin ≤3x ULN or direct bilirubin ≤1.5x ULN
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤5x ULN
- Alkaline Phosphatase <1.5x ULN
- International Normalized Ratio (INR) ≤1.4
- Model for End-Stage Liver Disease (MELD) score <12
- Platelet count ≥110 000/mL
- Albumin >3.4 g/dl
Who cannot join
- Major surgery (major according to the investigator's assessment) performed within 24-weeks prior to randomization, major surgery planned within 6 months after screening (e.g. hip replacement), or bariatric surgery within 2 years prior to randomization
- Any documented active or suspected malignancy or history of malignancy within 5-years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix. Specifically, any patients with suspected, confirmed, or history of hepatocellular carcinoma will be excluded
- Suspected or confirmed portal vein thrombosis within 6 months of enrollment
- History of liver transplantation
- Current listing for liver transplantation
- Present or past evidence of hepatic decompensation, in the opinion of the investigator, including but not limited to variceal hemorrhage, ascites, and/or hepatic encephalopathy
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- Patients with clinically significant portal hypertension defined by any one of the following:
- FibroScan ≥25 Kilo Pascal (kPA) if the platelets are ≥150,000/μL
- FibroScan ≥20 kPA if platelets are <150,000/μL
- Evidence of esophageal or gastric varices (≥grade1) on the most recent endoscopy
- Enhanced liver fibrosis (ELF) ≥11.3
- Hepatic venous pressure gradient (HVPG) ≥10 mm Hg
- further exclusion criteria apply
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
The Institute for Liver Health II dba Arizona Clinical Trials
Chandler, Arizona, 85225
Peak Gastroenterology Associates-Colorado Springs-67762
Colorado Springs, Colorado, 80907
Southern California Research Center
Coronado, California, 92118
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203
Houston Research Institute
Houston, Texas, 77079
Evolution Clinical Trials
Miami, Florida, 33122
Blessed Health Care
Miami, Florida, 33174-3245
Catalina Research Institute, LLC-Montclair-49051
Montclair, California, 91763
Knowledge Research Center
Orange, California, 92868
Progressive Medical Research
Port Orange, Florida, 32127
Inland Empire Clinical Trials, LLC
Rialto, California, 92377
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
Pinnacle Clinical Research, LLC
San Antonio, Texas, 78229
About this study
Official title: Safety, Tolerability and Pharmacodynamics of BI 770371 Administered Intravenously in Patients With Compensated Cirrhosis Due to MASH: a Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled Trial
This study is open to people with cirrhosis caused by a liver disease called MASH (metabolic dysfunction-associated steatohepatitis). The purpose of this study is to find out how well a medicine called BI 770371 is tolerated.
Participants are put into 2 groups by chance. One group gets BI 770371 as an infusion into a vein and the other group gets placebo as an infusion into a vein. Placebo infusions look like BI 770371 infusions but do not contain any medicine. Participants get an infusion every 3 weeks for 12 weeks.
Participants are in the study for about 5 months. During this time, they visit the study site 16 times. This also includes 1 overnight stay at the study site. The doctors regularly check participants' health and collect information on any health problems of the participants. The results are compared between the 2 groups.
- Being tested
- BI 770371, Placebo for BI 770371
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 770371Drug
BI 770371
Placebo for BI 770371Drug
Placebo for BI 770371
| Study group | Role | What they receive |
|---|---|---|
| BI 770371 | Experimental | Not described Receives: Drug: BI 770371 |
| Placebo for BI 770371 | Placebo comparator | Not described Receives: Drug: Placebo for BI 770371 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment-emergent, drug-related adverse events in the BI 770371 and placebo arms
Measured: Up to Week 15
Secondary outcomes (2)
Occurrence of adverse events (including clinically relevant findings from medical examination, safety laboratory tests, 12-lead ECG, vital signs, and assessment of local tolerability
Measured: Up to Week 22
Change from baseline in the fibrosis-related soluble biomarker PRO-C3 after 12 weeks of treatment
PRO = propeptide
Measured: Baseline , at Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start20 Jan 2025
- Primary completion13 Jan 2026
- Study completion13 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compensated 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06675929
- Sponsor's protocol ID
- 1501-0004
- Other IDs
- U1111-1307-2105
- Status last verified
- Apr 2026
- First submitted
- 4 Nov 2024
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacodynamics of BI 770371 Administered Intravenously in Patients With Compensated Cirrhosis Due to MASH: a Phase IIa, Multi-center, Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06675929
- Acronym / sponsor ID
- 1501-0004
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 13 Jan 2026 (actual)
- Study completion
- 13 Jan 2026 (actual)
- First posted
- 5 Nov 2024 (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.
This study is open to people with cirrhosis caused by a liver disease called MASH (metabolic dysfunction-associated steatohepatitis). The purpose of this study is to find out how well a medicine called BI 770371 is tolerated.
Participants are put into 2 groups by chance. One group gets BI 770371 as an infusion into a vein and the other group gets placebo as an infusion into a vein. Placebo infusions look like BI 770371 infusions but do not contain any medicine. Participants get an infusion every 3 weeks for 12 weeks.
Participants are in the study for about 5 months. During this time, they visit the study site 16 times. This also includes 1 overnight stay at the study site. The doctors regularly check participants' health and collect information on any health problems of the participants. The results are compared between the 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BI 770371 | Experimental | Drug: BI 770371 |
| Placebo for BI 770371 | Placebo comparator | Drug: Placebo for BI 770371 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- ≥18 to ≤75 years old
- Male or female participants
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
- Men able to father a child must be willing to use male contraception (condom or sexual abstinence) consistently and correctly until end of study. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information
- Signed and dated written informed consent in accordance with ICH-Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Key exclusion criteria (13 listed)
- Major surgery (major according to the investigator's assessment) performed within 24-weeks prior to randomization, major surgery planned within 6 months after screening (e.g. hip replacement), or bariatric surgery within 2 years prior to randomization
- Any documented active or suspected malignancy or history of malignancy within 5-years prior to screening, except appropriately treated basal cell carcinoma of the skin or in situ carcinoma of uterine cervix. Specifically, any patients with suspected, confirmed, or history of hepatocellular carcinoma will be excluded
- Suspected or confirmed portal vein thrombosis within 6 months of enrollment
- History of liver transplantation
- Current listing for liver transplantation
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 770371BI 770371 | Drug | BI 770371 |
| Placebo for BI 770371Placebo for BI 770371 | Drug | Placebo for BI 770371 |
Primary outcome
Occurrence of treatment-emergent, drug-related adverse events in the BI 770371 and placebo arms
Time frame: Up to Week 15
2 secondary outcomes
Occurrence of adverse events (including clinically relevant findings from medical examination, safety laboratory tests, 12-lead ECG, vital signs, and assessment of local tolerability
Time frame: Up to Week 22
Change from baseline in the fibrosis-related soluble biomarker PRO-C3 after 12 weeks of treatment
Time frame: Baseline , at Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section 'time frame' are fulfilled, researchers can use the following link https:// www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BI 770371 in people with Compensated Liver Cirrhosis and Metabolic Dysfunction Associated Steatohepatitis (MASH), run by Boehringer Ingelheim at 13 sites in United States.
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 15 inclusion and 13 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: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment-emergent, drug-related adverse events in the BI 770371 and placebo arms (time frame: Up to Week 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.