← Back to Search

Other

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks, 24 weeks, 48 weeks
Awards & highlights

ENLIVEN Trial Summary

This trial will test a new drug, BIO89-100, to see if it is safe and effective in treating patients with a certain kind of liver disease.

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.Check my eligibility
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.See study design
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.

ENLIVEN Trial 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.

ENLIVEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks, 24 weeks, 48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks, 24 weeks, 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Main: Proportion of participants with histological resolution of NASH without worsening of fibrosis
Main: Proportion of participants with ≥1 stage decrease in fibrosis stage with no worsening of NASH
Secondary outcome measures
Main: Absolute and percentage change from baseline in Adiponectin
Main: Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol
Main: Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol
+10 more

ENLIVEN Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: BIO89-100 - 44 mg Q2WExperimental Treatment1 Intervention
Group II: Experimental: BIO89-100 - 30 mg QWExperimental Treatment1 Intervention
Group III: BIO89-100 - 15 mg QWExperimental Treatment1 Intervention
Group IV: Placebo Comparator: Placebo QWPlacebo Group1 Intervention
Group V: Placebo Comparator: Placebo Q2WPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIO89-100
2021
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

89bio, Inc.Lead Sponsor
5 Previous Clinical Trials
1,604 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
1,159 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Charlton, MDStudy Director89bio, Inc.
1 Previous Clinical Trials
101 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
101 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Millie Goattwald, PharmDStudy Director89bio, Inc.

Media Library

BIO89-100 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04929483 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: BIO89-100 - 15 mg QW, Placebo Comparator: Placebo QW, Experimental: BIO89-100 - 30 mg QW, Experimental: BIO89-100 - 44 mg Q2W, Placebo Comparator: Placebo Q2W
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: BIO89-100 Highlights & Side Effects. Trial Name: NCT04929483 — Phase 2
BIO89-100 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929483 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT04929483 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who would be eligible to partake in this medical trial?

"This clinical trial is seeking 216 individuals between the ages of 21 and 75 who have been biopsy-confirmed to possess nonalcoholic steatohepatitis with fibrosis stage F2 or F3 according to NASH CRN System classification. Each patient must also display a score of 1 in each category (steatosis, ballooning degeneration, and lobular inflammation) on their qualifying biopsy - which should be conducted within 6 months prior to screening visit or during the screening period itself."

Answered by AI

What potential risks could arise from using BIO89-100?

"Our team at Power assigned BIO89-100 a safety rating of 2, as while it has been tested in preclinical trials and demonstrated its security, there is no evidence yet to back up the efficacy of this medication."

Answered by AI

Are individuals currently being accepted into this clinical experiment?

"The clinicaltrials.gov website reveals that this particular medical trial is not currenlty looking for new participants, as the last update to it was on September 5th 2022. Despite this study's inactivity, there are 233 other trials presently recruiting volunteers."

Answered by AI

Is eligibility for this experiment restricted to those aged 30 and over?

"To be considered for this trial, patients must have an age between 21 and 75. Those below 18 or above 65 can look into the 22 trials dedicated to minors or 191 studies focusing on seniors respectively."

Answered by AI

How many medical facilities are participating in this research endeavor?

"At present, 72 medical centres across the country are recruiting participants for this trial. San Diego, Huntington Beach and Westlake represent some of these sites; however there are many more locales where enrolment is possible. To make participation more comfortable, it would be prudent to select a clinic in close proximity to reduce required travel time."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
New York
Other
Texas
How old are they?
18 - 65
What site did they apply to?
89bio Clinical Study Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0

What questions have other patients asked about this trial?

How long is the study?
PatientReceived 2+ prior treatments

Why did patients apply to this trial?

My family died of liver cancer. I want to know what's wrong with me!
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
2021. "Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04929483.
All > Autoimmune Hepatitis > Nash
~58 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top