BIO89-100 for Fatty Liver Disease (ENLIVEN Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: 89bio, Inc.

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called BIO89-100 in people with a liver disease called NASH, who have moderate to severe liver scarring. The drug aims to help the liver heal by reducing damage and improving its function.

Eligibility Criteria

This trial is for adults aged 21-75 with a specific liver condition called NASH, showing moderate to severe scarring on their liver. Participants must have had a confirming biopsy within the last 6 months. Those with uncontrolled high blood pressure, type 1 diabetes or poorly managed type 2 diabetes, cirrhosis, or a BMI under 25 are not eligible.

Inclusion Criteria

My liver condition is confirmed by biopsy with specific damage and inflammation levels.

I am between 21 and 75 years old.

Exclusion Criteria

My high blood pressure is not well-managed.

I have type 1 diabetes or my type 2 diabetes is not well-controlled.

I have been diagnosed with or show signs of cirrhosis.

Treatment Details

The study tests BIO89-100's safety and effectiveness in treating NASH with significant fibrosis. It's randomized and double-blind, meaning participants will be randomly assigned to receive either BIO89-100 or a placebo without knowing which one they're getting.

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension)Experimental Treatment2 Interventions

Placebo QW (Main study)/ BIO89-100 - 30 mg QW (Extension)

Group II: BIO89-100 - 44 mg once every 2 weeks (Q2W)Experimental Treatment1 Intervention

BIO89-100 - 44 mg Q2W

Group III: BIO89-100 - 30 mg QWExperimental Treatment1 Intervention

BIO89-100 - 30 mg QW

Group IV: BIO89-100 - 15 mg once weekly (QW)Experimental Treatment1 Intervention

BIO89-100 - 15 mg QW

Group V: Placebo QWPlacebo Group1 Intervention