BI 3006337 for Fatty Liver Disease

Recruiting in Palo Alto (17 mi)

+22 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new medicine called BI 3006337 in adults who are overweight or obese and have fatty liver disease. The goal is to find out how much of the medicine they can safely take. Participants receive regular injections and are closely monitored for any health issues.

Eligibility Criteria

Adults aged 18-75 with overweight or obesity (BMI of 25-40) and fatty liver disease can join this study. They must not drink alcohol excessively, use certain medications that affect the liver, or have other types of liver diseases. Women who can bear children and men with partners who can must agree to effective birth control.

Inclusion Criteria

I am between 18 and 75 years old.

Exclusion Criteria

I haven't taken medications known to harm the liver for more than 2 weeks in the last 3 months.

I do not have liver disease except for simple fat buildup.

I have or might have liver cancer.

I have been diagnosed with type 1 diabetes.

Participant Groups

The trial is testing different doses of a new medicine called BI 3006337 versus a placebo in people with fatty liver disease and obesity. Participants are randomly assigned to one of four groups for about four months, receiving weekly injections while their health is monitored.

4Treatment groups

Experimental Treatment

Group I: BI 3006337 dose group 4Experimental Treatment1 Intervention

Group II: BI 3006337 dose group 3 or placeboExperimental Treatment2 Interventions

Group III: BI 3006337 dose group 2 or placeboExperimental Treatment2 Interventions

Group IV: BI 3006337 dose group 1 or placeboExperimental Treatment2 Interventions