BI 770371 for Fatty Liver Disease

Not currently recruiting at 14 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Boehringer Ingelheim

Disqualifiers: Major surgery, Malignancy, Liver transplantation, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 16

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the tolerance of an experimental treatment, BI 770371, in individuals with MASH-related liver disease, which can lead to cirrhosis. Participants will be randomly assigned to receive either the medication or a placebo (a substance with no active medicine) via infusion every three weeks for 12 weeks. The study targets individuals diagnosed with cirrhosis due to MASH who meet specific health criteria, such as stable liver function. Over the five-month trial, participants will attend 16 visits, including one overnight stay, to monitor health and potential side effects. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant medical advancements.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that BI 770371 is likely to be safe for humans?

Research shows that the safety of BI 770371 is still under investigation. This trial examines how well individuals with cirrhosis from MASH (a type of fatty liver disease) tolerate this new medicine. As a Phase 2 trial, it builds on earlier safety studies.

In early trials, medicines like BI 770371 undergo testing to ensure safety for people. Although specific safety details for BI 770371 are not available, reaching this phase indicates it was safe enough in earlier studies. This stage is crucial for gaining more insight into its safety and potential side effects. Participants will receive regular health checks to monitor for any health issues. ^{1 2 3 4 5}

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

Unlike the standard treatments for fatty liver disease, which often involve lifestyle changes and medications that target symptoms like insulin resistance or high cholesterol, BI 770371 offers a novel approach. Researchers are excited about BI 770371 because it directly targets the underlying mechanisms of fatty liver disease, potentially offering more effective results. This experimental drug uses a new active ingredient that may address the root causes of liver fat accumulation, setting it apart from current options. Such innovations could mean more efficient treatment and better outcomes for patients with this condition.

What evidence suggests that BI 770371 might be an effective treatment for fatty liver disease?

Research suggests that BI 770371, which participants in this trial may receive, might help treat metabolic dysfunction-associated steatohepatitis (MASH). MASH is a type of fatty liver disease characterized by liver inflammation and damage. Although specific data on BI 770371 remains limited, the drug targets the causes of liver inflammation and damage. This targeting could potentially reduce liver injury and improve liver health. Early results from other treatments with similar mechanisms show promise in managing fatty liver diseases like MASH. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with cirrhosis due to MASH, having specific levels of liver enzymes and bilirubin. They must understand the study and agree to use effective contraception. People with certain liver enzyme levels beyond set limits cannot join.

Inclusion Criteria

My total bilirubin is ≤1.5 mg/dL and direct bilirubin is <50% of that.

My liver enzymes AST and ALT are within normal limits.

My alkaline phosphatase levels are below 1.5 times the upper limit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BI 770371 or placebo as an infusion every 3 weeks for 12 weeks

12 weeks

16 visits (in-person), including 1 overnight stay

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 770371

Trial Overview The trial tests how well a new medicine called BI 770371 is tolerated in people with MASH-related cirrhosis. Participants are randomly assigned to receive either BI 770371 or a placebo via infusion every three weeks for twelve weeks.

How Is the Trial Designed?

Group I: BI 770371 Experimental Treatment 1 Intervention

Group II: Placebo for BI 770371 Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9127863/

Nonalcoholic fatty liver disease and health outcomes NAFLD affects up to 25% of adults, up to 3~10% of the Western pediatric population and increases up to 70% among obese children. Many research ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8324680/

Non-alcoholic fatty liver disease and steatohepatitis Long-term efficacy of rosiglitazone in nonalcoholic steatohepatitis: results of the fatty liver improvement by rosiglitazone therapy (FLIRT 2) extension trial.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7132013/

Non-alcoholic Fatty Liver Disease: Growing Burden, Adverse ... This review discusses the growing burden of NAFLD, its outcomes, and adverse associations with various diseases.

4. withpower.com withpower.com/clinical-trials/for-fatty-liver-disease?page=2

Top Fatty Liver Disease Clinical Trials | Power This trial is testing two new experimental drugs used together to treat adults with a serious liver disease. The combination is expected to be more effective ...

5. malacards.org malacards.org/card/metabolic_dysfunction_associated_steatohepatitis

Metabolic Dysfunction-Associated Steatohepatitis Metabolic dysfunction-associated steatohepatitis is a liver disease characterized by inflammation, hepatocyte injury like ballooning, and possible fibrosis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8106107/

Non-alcoholic fatty liver diseases: current challenges and ... Prospective data, actually suggest that NAFLD patients with regular alcohol intake, although within the safe thresholds, are at higher risk of liver disease ...

7. malacards.org malacards.org/card/fatty_liver_disease_1

Fatty Liver Disease 1 Fatty liver disease 1, also known as hepatic steatosis, is characterized by the accumulation of excess triglycerides in the liver.

8. ctv.veeva.com ctv.veeva.com/site/american-research-corporation-at-the-texas-liver-institute-san-antonio-tx

American Research Corporation at the Texas Liver Institute A Study to Test How Well BI 770371 is Tolerated by People With Cirrhosis Caused by a Liver Disease Called MASH. This study is open to people with cirrhosis ...

9. actgnetwork.org actgnetwork.org/clinical-trial/a5371-a-single-arm-open-label-pilot-study-of-semaglutide-for-non-alcoholic-fatty-liver-disease-nafld-a-metabolic-syndrome-with-insulin-resistance-increased-hepatic-lipids-and-increased-cardiov/

A5371: A Single-Arm, Open-Label, Pilot Study of ... The purpose of this study is to evaluate the safety and tolerability of a drug called semaglutide and to see if it can reduce the amount of fat stored in the ...