All > Fatty Liver > Spokane

BIO89-100 for Non-alcoholic Fatty Liver Disease

89bio Clinical Study Site, San Antonio, TX
Non-alcoholic Fatty Liver DiseaseBIO89-100 - Drug
Eligibility
21 - 75
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
FLT190
1
Levonorgestrel-Releasing Intrauterine System
1
F18-DCFPyL

Study Objectives

4 Primary · 19 Secondary · Reporting Duration: 12 Weeks, 24 Weeks, 48 Weeks

Week 48
Absolute and percentage change from baseline in Adiponectin
Absolute and percentage change from baseline in High Density Lipoprotein (HDL) Cholesterol
High Density Lipoproteins
Absolute and percentage change from baseline in serum triglycerides
Absolute change and percentage change from baseline in Magnetic Resonance Imaging - Hepatic Fat Fraction (MRI-PDFF)
Absolute change and percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3)
Mean absolute change and percentage change from baseline in Alanine Transaminase (ALT)
Mean absolute change and percentage change from baseline in Magnetic Resonance Imaging - Hepatic Fat Fraction (MRI-PDFF)
Mean absolute change and percentage change from baseline in N-terminal type III collagen propeptide (Pro-C3)
Percentage change from baseline in Adiponectin
Percentage change from baseline in HbA1c
Percentage change from baseline in triglycerides
Week 48
Absolute and percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol
Percentage change from baseline in Low Density Lipoprotein (LDL) Cholesterol
24 Weeks
Percentage of participants with NASH resolution AND with ≥1 point decrease in fibrosis stage
Percentage of participants with at least a 2-point improvement in NAS and no worsening of fibrosis
Percentage of participants with histological resolution of NASH without worsening of fibrosis
Percentage of participants with ≥1 point decrease in fibrosis stage with no worsening of NASH
Proportion of participants with NASH resolution AND with ≥1 stage decrease in fibrosis stage
Proportion of participants with at least a 2-point improvement in NAS and no worsening of fibrosis
Proportion of participants with histological resolution of NASH without worsening of fibrosis
Proportion of participants with ≥1 stage decrease in fibrosis stage with no worsening of NASH
Week 48
Steady-state blood level of BIO89-100

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
FLT190
2
Levonorgestrel-Releasing Intrauterine System
2
F18-DCFPyL

Trial Design

5 Treatment Groups

BIO89-100 - 15 mg QW
1 of 5
Experimental: BIO89-100 - 44 mg Q2W
1 of 5
Experimental: BIO89-100 - 30 mg QW
1 of 5
Placebo Comparator: Placebo QW
1 of 5
Placebo Comparator: Placebo Q2W
1 of 5

Experimental Treatment

Non-Treatment Group

216 Total Participants · 5 Treatment Groups

Primary Treatment: BIO89-100 · Has Placebo Group · Phase 2

BIO89-100 - 15 mg QW
Drug
Experimental Group · 1 Intervention: BIO89-100 · Intervention Types: Drug
Experimental: BIO89-100 - 44 mg Q2W
Drug
Experimental Group · 1 Intervention: BIO89-100 · Intervention Types: Drug
Experimental: BIO89-100 - 30 mg QW
Drug
Experimental Group · 1 Intervention: BIO89-100 · Intervention Types: Drug
Placebo Comparator: Placebo QW
Drug
PlaceboComparator Group · 1 Intervention: BIO89-100 · Intervention Types: Drug
Placebo Comparator: Placebo Q2W
Drug
PlaceboComparator Group · 1 Intervention: BIO89-100 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIO89-100
2021
Completed Phase 2
~200

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks, 24 weeks, 48 weeks

Who is running the clinical trial?

89bio, Inc.Lead Sponsor
4 Previous Clinical Trials
554 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
8 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Charlton, MDStudy Director89bio, Inc.
1 Previous Clinical Trials
101 Total Patients Enrolled
Millie Goattwald, PharmDStudy Director89bio, Inc.
Millie Gottwald, PharmDStudy Director89bio, Inc.
2 Previous Clinical Trials
102 Total Patients Enrolled

Eligibility Criteria

Age 21 - 75 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Georgia50.0%
New York50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
89bio Clinical Study Site100.0%
What portion of applicants met pre-screening criteria?
Met criteria50.0%
Did not meet criteria50.0%
Why did patients apply to this trial?
  • "I want to know what's wrong with me!"
What questions have other patients asked about this trial?
  • "How long is the study?"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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