BI 1584862 for Liver Failure

Recruiting at 3 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Disqualifiers: Uncontrolled diabetes, Severe renal, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how the body processes a medicine called BI 1584862, a potential new drug, in individuals with varying levels of liver problems. It includes participants with mild, moderate, and severe liver issues, as well as those without liver problems for comparison. The trial suits both individuals living with liver problems and healthy participants. Participants will visit the study site three times over approximately five weeks, including a four-night stay for close health monitoring. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial does not specify that you need to stop taking your current medications. In fact, participants with liver problems may continue their regular treatment during the study.

Is there any evidence suggesting that BI 1584862 is likely to be safe for humans?

Research has shown that BI 1584862 is being tested to assess its safety and how it moves through the body in individuals with varying liver health. As this is an early-stage study, limited information exists about its safety in humans. Early trials primarily focus on evaluating safety and determining the correct dosage. Thus, only partial safety information is available at this stage.

Participants in this study will receive close monitoring. Doctors will regularly assess their health and watch for any side effects. This careful monitoring helps identify potential issues quickly. While these early trials are crucial for understanding how well the treatment is tolerated, further research is necessary to fully comprehend its safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for liver failure?

Unlike the standard treatments for liver failure, which often focus on managing symptoms or the underlying causes such as alcohol use or hepatitis, BI 1584862 is unique because it targets the liver's function directly. Researchers are excited about BI 1584862 because it could offer a new mechanism of action that enhances liver function in patients with varying degrees of hepatic impairment. This approach might provide a more direct and potentially faster way to improve liver health compared to existing therapies.

What evidence suggests that BI 1584862 might be an effective treatment for liver failure?

Research is investigating BI 1584862 as a potential treatment for liver failure. This trial will examine BI 1584862 in participants with varying levels of hepatic impairment—mild, moderate, and severe—as well as those with normal hepatic function. Early studies focus on how the drug is absorbed and processed in individuals with different levels of liver issues. Limited data exists on its effectiveness for liver failure, but researchers are studying it closely to determine its potential benefits. The aim is for BI 1584862 to offer a new way to support liver function in the future. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

Adults aged 18-80 with a BMI of 18-42 kg/m2 can join this study, which includes those with varying degrees of liver problems and healthy individuals for comparison. Participants must be sexually abstinent or use contraception, and provide informed consent.

Inclusion Criteria

I meet all the required conditions to participate.

I am either male or female.

My BMI is between 18.0 and 42.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants take a single dose of BI 1584862. Participants with liver problems are treated in a step-by-step approach with a few days in between for data review and tolerance assessment.

1 week

1 visit (in-person), includes an overnight stay for 4 nights

Follow-up

Participants are monitored for safety and effectiveness after treatment. Health checks and blood samples are taken to assess study endpoints.

3 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BI 1584862

Trial Overview The trial is testing how the body processes BI 1584862 in people with different levels of liver health. It involves one dose of the medication, step-by-step treatment for those with liver issues, regular health checks, blood samples collection, and a few overnight stays.

How Is the Trial Designed?

Group I: Participants with severe hepatic impairment (Child-Pugh C) Experimental Treatment 1 Intervention

Group II: Participants with normal hepatic function Experimental Treatment 1 Intervention

Group III: Participants with moderate hepatic impairment (Child-Pugh B) Experimental Treatment 1 Intervention

Group IV: Participants with mild hepatic impairment (Child-Pugh A) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06957756

A Study to Test How BI 1584862 is Taken up in the Blood ... A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems. ClinicalTrials.gov ID NCT06957756.

2. withpower.com withpower.com/trial/phase-1-hepatic-insufficiency-5-2025-e2df4

BI 1584862 for Liver Failure This study includes people with mild, moderate, and severe liver problems, and people without liver problems as a matching control. The purpose of this study is ...

3. ichgcp.net ichgcp.net/amp/clinical-trials-registry/NCT06957756

BI 1584862 in Hepatic Insufficiency - Clinical Trials Registry - ICH GCP This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m2 can take part.

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/boehringer-trial-bi-1584862/

Boehringer Ingelheim begins Phase II trial of BI 1584862 ... Boehringer Ingelheim has begun the JADE Phase II trial to evaluate BI 1584862 as a first-in-class oral treatment for geographic atrophy.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11724149/

New Insights Into Hepatic Impairment (HI) Trials - PMC This review aimed at looking into the data from dedicated HI studies, cluster these data into various categories and connect the effect by HI with reported ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0031307

Hepatic Insufficiency (DBCOND0031307) A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems ... Study Examining The Effect Of Hepatic Impairment On Safety ...

7. malacards.org malacards.org/card/infantile_liver_failure_syndrome_1

Infantile Liver Failure Syndrome 1 Infantile liver failure syndrome 1 is a rare genetic disease that affects the liver, leading to acute liver failure in the first year of life.