What is the mechanism of action of this treatment?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD), including those similar to BIO89-100, often work by modulating metabolic pathways to reduce liver fibrosis and inflammation. These treatments may involve the use of fibroblast growth factor analogues, which help regulate lipid metabolism and insulin sensitivity, thereby reducing liver fat accumulation and fibrosis. Additionally, anti-inflammatory agents can decrease liver inflammation, a key factor in the progression of NAFLD to non-alcoholic steatohepatitis (NASH). By targeting these metabolic and inflammatory pathways, these treatments aim to halt or reverse liver damage, improving liver function and overall health outcomes for patients with NAFLD.

What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) that modulate metabolic pathways, such as pioglitazone, vitamin E, SGLT2 inhibitors, and GLP-1 receptor agonists, have various side effects. Pioglitazone can cause weight gain, edema, and an increased risk of bone fractures. Vitamin E is generally well-tolerated but may increase the risk of hemorrhagic stroke. SGLT2 inhibitors can lead to urinary tract infections and genital infections. GLP-1 receptor agonists may cause gastrointestinal issues like nausea and vomiting. These side effects should be discussed with a healthcare provider to determine the best treatment plan.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD) or Non-alcoholic Steatohepatitis (NASH). However, several drugs are being studied for their potential benefits in these conditions. These include agents like pioglitazone, which improves insulin sensitivity, and obeticholic acid, a farnesoid X receptor (FXR) agonist that modulates bile acid pathways and has shown promise in reducing liver fibrosis. Other investigational drugs target metabolic pathways and inflammation, similar to the mechanism of action expected for BIO89-100.

What other types of research exist?

Promising novel alternatives to BIO89-100 for NAFLD/NASH patients include AXA1125 and AXA1957, which are endogenous metabolic modulators designed to support multiple metabolic and fibroinflammatory pathways. Additionally, evinacumab, an ANGPTL3 monoclonal antibody, has shown significant LDL-C reduction and may offer benefits in lipid metabolism relevant to NAFLD/NASH.

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BIO89-100 for Fatty Liver Disease (ENLIVEN Trial)

Phase 2

Waitlist Available

Research Sponsored by 89bio, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy-confirmed NASH with fibrosis stage F2 or F3 per NASH CRN System and NAS ≥4, with a score of at least 1 in each of steatosis, ballooning degeneration, and lobular inflammation

Age 21 to 75

Must not have

Have poorly controlled high blood pressure

Have type 1 diabetes or poorly controlled type 2 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up blood samples for pk analysis collected at up to 8 study visits over the course of approximately 48 weeks

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the specific side effects of BIO89-100 are not detailed here, common side effects in trials like this may include injection site reactions, gastrointestinal discomforts such as nausea or diarrhea, fatigue, and potential liver-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am between 21 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My high blood pressure is not well-managed.

Select...

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

Select...

I have been diagnosed with or show signs of cirrhosis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ blood samples for pk analysis collected at up to 8 study visits over the course of approximately 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~blood samples for pk analysis collected at up to 8 study visits over the course of approximately 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples for pk analysis collected at up to 8 study visits over the course of approximately 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Main: Steady-state blood level of BIO89-100

Trial Design

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

Placebo QW

Group VI: Placebo Q2WPlacebo Group1 Intervention

Placebo Q2W

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

BIO89-100

2021

Completed Phase 1

~10

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD), including those similar to BIO89-100, often work by modulating metabolic pathways to reduce liver fibrosis and inflammation. These treatments may involve the use of fibroblast growth factor analogues, which help regulate lipid metabolism and insulin sensitivity, thereby reducing liver fat accumulation and fibrosis. Additionally, anti-inflammatory agents can decrease liver inflammation, a key factor in the progression of NAFLD to non-alcoholic steatohepatitis (NASH). By targeting these metabolic and inflammatory pathways, these treatments aim to halt or reverse liver damage, improving liver function and overall health outcomes for patients with NAFLD.

Molecular mechanisms and the role of saturated fatty acids in the progression of non-alcoholic fatty liver disease.