BI 770371 for Fatty Liver Disease

Recruiting in Palo Alto (17 mi)

+6 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Boehringer Ingelheim

Disqualifiers: Major surgery, Malignancy, Liver transplantation, others

Prior Safety Data

Trial Summary

What is the purpose of this 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.

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.

Research Team

Eligibility Criteria

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.

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Trial Timeline

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

Treatment Details

Interventions

BI 770371 (Other)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: BI 770371Experimental Treatment1 Intervention

Group II: Placebo for BI 770371Placebo Group1 Intervention