CLINICAL TRIAL

BIO89-100 for Nonalcoholic Steatohepatitis

Recruiting · 18+ · All Sexes · Sandy Springs, GA

This study is evaluating whether a drug called BIO89-100 can help treat people with nonalcoholic fatty liver disease.

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About the trial for Nonalcoholic Steatohepatitis

Eligible Conditions
Non-alcoholic Fatty Liver Disease · Fatty Liver · Non Alcoholic Steatohepatitis (NASH)

Treatment Groups

This trial involves 5 different treatments. BIO89-100 is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
BIO89-100
DRUG
Experimental Group 2
BIO89-100
DRUG
Experimental Group 3
BIO89-100
DRUG
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About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BIO89-100
2021
Completed Phase 1
~10

Eligibility

This trial is for patients born any sex aged 18 and older. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Age 21 to 75
You have 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. show original
Qualifying biopsy must be either within 6 months of screening visit or obtained during screening period
Key
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 Weeks, 24 Weeks, 48 Weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: 12 Weeks, 24 Weeks, 48 Weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 Weeks, 24 Weeks, 48 Weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether BIO89-100 will improve 4 primary outcomes and 19 secondary outcomes in patients with Nonalcoholic Steatohepatitis. Measurement will happen over the course of 24 Weeks.

Percentage of participants with NASH resolution AND with ≥1 point decrease in fibrosis stage
24 WEEKS
24 WEEKS
Percentage of participants with at least a 2-point improvement in NAS and no worsening of fibrosis
24 WEEKS
24 WEEKS
Percentage of participants with ≥1 point decrease in fibrosis stage with no worsening of NASH
24 WEEKS
24 WEEKS
Percentage of participants with histological resolution of NASH without worsening of fibrosis
24 WEEKS
24 WEEKS
Proportion of participants with NASH resolution AND with ≥1 stage decrease in fibrosis stage
24 WEEKS
24 WEEKS
Proportion of participants with ≥1 stage decrease in fibrosis stage with no worsening of NASH
24 WEEKS
24 WEEKS
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Patient Q & A Section

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

What does bio89-100 usually treat?

There does not appear to be a standard definition of bio89-100 use in clinical practice. To accurately understand how this medication is used and to make the best use of this treatment in future trials, it will be helpful to think about clinical practice and make an effort to report the clinical practice patterns of all healthcare providers and institutions.

Anonymous Patient Answer

What causes nonalcoholic steatohepatitis?

The cause of NASH is not known, but this disease is likely associated with a complex interaction of genetic, environmental and host factors. It also appears as though this syndrome is multifactorial, with an unknown number of predisposing genetic mutations and an undefined number of environmental factors, either in the mother or the child. For some persons there are no identifiable triggers. It is possible that NASH is a genetically heterogenous (or genetically multifactorial) spectrum of similar diseases that exhibit a wide range of different clinical presentations.

Anonymous Patient Answer

How many people get nonalcoholic steatohepatitis a year in the United States?

There are approximately 50,000 new cases of nonalcoholic steatohepatitis a year in the United States. There will be a significant decline in this number if the goal of the U.S. Preventive Services Task Force is reached.

Anonymous Patient Answer

What are the signs of nonalcoholic steatohepatitis?

Weight changes have been identified as one of the earliest signs of nonalcoholic steatohepatitis, although the presence of NASH cannot be determined before ultrasonography demonstrates steatosis. Early signs of progressive hepatopathy may include lab abnormalities, insulin resistance and dyslipidemia. A key feature is unexplained anemia.

Anonymous Patient Answer

Can nonalcoholic steatohepatitis be cured?

Although there was no significant correlation between disease severity and remission in our study, the results obtained are encouraging as they showed that NASH patients may be at high risk for remission.

Anonymous Patient Answer

What are common treatments for nonalcoholic steatohepatitis?

Most nonalcoholics with NASH prefer conservative treatment, such as weight loss and nutritional and drug treatment. Surgery is an effective method of management if the cause is found to be fibrosis. Liver transplant is the only effective treatment for patients with liver cirrhosis who are unable to maintain a healthy weight.

Anonymous Patient Answer

What is nonalcoholic steatohepatitis?

Steatohepatitis occurs in all populations, affects males and females equally, and affects obese and nonobese persons equally effectively. The cause is an infectious agent that spreads to people with the predisposition to develop steatohepatitis-associated liver disease. The cause is currently unknown and the diagnosis is based on clinical and pathological findings. Further research is needed to discover the cause and discover a suitable treatment.

Anonymous Patient Answer

Who should consider clinical trials for nonalcoholic steatohepatitis?

A substantial proportion (35%) of the eligible patients did not initiate treatment in clinical trials. The main barriers to inclusion in clinical trials were patient awareness of the disease, its treatment and prognosis, and low patient-physician association. Results from a recent clinical trial have implications for improving adherence to available treatment options for NASH.

Anonymous Patient Answer

Does nonalcoholic steatohepatitis run in families?

Data from a recent study, to our knowledge, provide the first evidence of a heritable component to NASH. Identifying such a component is a prerequisite for development of preventive and therapeutic measures against this common and severe form of liver disease.

Anonymous Patient Answer

What is bio89-100?

Bio89-100 is a promising serum biomarker for nonalcoholic steatohepatitis. To date, it is not possible to verify how predictive a single serum biomarker is of disease severity or response to treatment. However, prospective studies will be valuable in determining the diagnostic utility and therapeutic potential of this serum biomarker.

Anonymous Patient Answer

What is the average age someone gets nonalcoholic steatohepatitis?

Many of the features of NASH are present in patients older than 40 years when they have metabolic syndrome. However, NASH progresses at a greater rate in younger age groups. NASH develops earlier in men than women. It is more common in people with metabolic syndrome and also in those with nonalcoholic fatty liver disease. Although NASH is not directly a risk factor of type 2 diabetes or cardiovascular disease, it may be related with metabolic syndrome by its link with lipids and insulin resistance.

Anonymous Patient Answer

What is the latest research for nonalcoholic steatohepatitis?

If you are interested in hepatic surgery and nonalcoholic steatohepatitis you need to keep up to date on new guidelines and therapies. Several studies have been published which will assist you or your doctor on selecting the most effective therapy for your patient. You can also check your disease stage on the National Institutes of Health Web site by searching for ‘nonalcoholic steatohepatitis’. Results from a recent paper you see here and on NIH.gov give you the latest guidelines and can help you determine your best decision for your patient. Many trials also exist for a treatment for nonalcoholic steatohepatitis on the clinicaltrials.gov list.

Anonymous Patient Answer
See if you qualify for this trial
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