BI 3802876 for Liver Cirrhosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new medicine, BI 3802876, for individuals with compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH). The goal is to assess how well different doses of this medicine are tolerated and processed by the body and whether it can improve liver health. Participants receive either the medicine or a placebo (a non-active substance) through a vein infusion. This study is suitable for adults diagnosed with compensated MASH cirrhosis who have not experienced any severe liver issues in the past. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that BI 3802876 is likely to be safe for humans?
Research has shown that BI 3802876 has been tested in healthy individuals to assess its safety and tolerability. In these studies, researchers administered varying doses to observe the body's reactions. Most participants tolerated BI 3802876 well, experiencing no serious problems or side effects.
Although specific details from these studies are not provided here, the testing of BI 3802876 for liver cirrhosis suggests it demonstrated a good safety profile in earlier tests. This study aims to determine how well individuals with liver conditions tolerate the medication. Researchers will closely monitor participants for any health issues during treatment.12345Why do researchers think this study treatment might be promising for liver cirrhosis?
Researchers are excited about BI 3802876 for liver cirrhosis because it offers a novel approach compared to existing treatments like lifestyle changes, medications such as diuretics, and liver transplants. Unlike these current options, BI 3802876 is designed to target specific pathways involved in liver fibrosis, potentially slowing down or reversing liver damage. This targeted action could lead to more effective management of cirrhosis with fewer side effects, addressing an urgent need for patients with limited treatment choices.
What evidence suggests that BI 3802876 might be an effective treatment for liver cirrhosis?
Research shows that BI 3802876 is being developed to improve liver health in individuals with liver cirrhosis caused by Metabolic Dysfunction-Associated Steatohepatitis (MASH). Although limited data exists on its effectiveness in humans, this trial will test various dosages of BI 3802876 to assess its absorption and tolerance in the body. The goal is to determine if BI 3802876 can slow down or reverse liver damage in this condition. While solid proof of its effectiveness is not yet available, the drug's mechanism suggests potential benefits for liver health.12678
Are You a Good Fit for This Trial?
Adults aged 18-75 with compensated liver cirrhosis due to MASH are eligible for this trial. They must have specific test results indicating advanced liver fibrosis or cirrhosis, and a biopsy confirming the condition within the last 5 years. Those in Child-Pugh category A without previous decompensation events can join.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive BI 3802876 or placebo as an infusion into a vein. Participants are in the study for about half a year, visiting the study site 12 times, with 2 visits for receiving the study medicine.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with doctors collecting information on health problems and blood samples.
What Are the Treatments Tested in This Trial?
Interventions
- BI 3802876
Trial Overview
The study tests how well people tolerate BI 3802876, a new medication aimed at improving liver health in MASH patients. Participants receive either different doses of BI 3802876 or a placebo via infusion and are monitored over six months through visits and blood samples.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor
Citations
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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 ...
BI 3802876 for Liver Cirrhosis · Info for Participants
The purpose of this study is to find out how well a study medicine called BI 3802876 is tolerated in people with this condition.
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ctv.veeva.com/study/a-study-to-test-whether-bi-3802876-is-tolerated-in-people-with-compensated-liver-cirrhosis-due-to-meA Study to Test Whether BI 3802876 is Tolerated in People ...
The purpose of this study is to find out how well a study medicine called BI 3802876 is tolerated in people with this condition.
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ctv.veeva.com/study/a-study-in-healthy-men-to-test-how-well-different-doses-of-bi-3802876-are-toleratedA Study in Healthy Men to Test How Well Different Doses of BI ...
The main objective of this trial is to investigate the safety, tolerability, and pharmacokinetics of BI 3802876 when administered in ...
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