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BI 770371 for Fatty Liver Disease

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* ≥18 to ≤75 years old
* For patients with Gilbert's syndrome: total bilirubin ≤3x upper limit of normal (ULN) or direct bilirubin ≤1.5x ULN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline , at week 12

Summary

This trial is for people with liver cirrhosis caused by a liver disease called MASH. The purpose is to see how well a medicine called BI 770371 is tolerated. Participants are randomly divided

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects of BI 770371 are not specified here, common side effects from similar treatments may include reactions at the infusion site, fatigue, nausea, and potential liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 75 years old.
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My bilirubin levels are within the required range for Gilbert's syndrome.
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My liver function is mildly affected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline , at week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline , at week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in the fibrosis-related soluble biomarker PRO-C3 after 12 weeks of treatment

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 770371Experimental Treatment1 Intervention
Group II: Placebo for BI 770371Placebo Group1 Intervention

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Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,551 Previous Clinical Trials
15,858,001 Total Patients Enrolled
~16 spots leftby Dec 2025
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