Diagnostic Assay for Liver Disease

(AGEDDX Trial)

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Active Genomes Expressed Diagnostics, Corp

Must not be taking: Anti-coagulation, Anti-platelet

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on developing a new test to identify and understand liver diseases such as fatty liver and NASH, a more serious liver condition. Researchers aim to find biomarkers (biological indicators) in the blood to help diagnose these conditions and assess the extent of liver fibrosis (scarring). The trial includes healthy participants and those with liver issues confirmed by a recent biopsy. It suits individuals who suspect they have metabolic syndrome or non-alcoholic fatty liver disease and have undergone a liver biopsy in the past couple of years. As an Early Phase 1 trial, this research seeks to understand how the test functions in people, offering participants a chance to contribute to groundbreaking diagnostic advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anti-coagulation or anti-platelet therapy.

What prior data suggests that this diagnostic assay is safe for liver disease assessment?

Research has shown that the AGED Diagnostics Liver Disease Assessment remains in the early stages. The focus is on verifying markers for liver conditions. As this trial is just beginning, limited safety information is available. Early trials primarily aim to ensure the method's effectiveness and safety for participants.

This assessment uses blood tests to detect liver diseases. Blood tests are generally safe due to their non-invasive nature. Although specific safety data for this test is not yet available, blood tests rarely cause major side effects. Participants might experience minor discomfort, such as bruising or dizziness, from the blood draw.

As more information becomes available, it will help confirm the test's safety and reliability. For now, participants can expect minimal risk from joining this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AGED Diagnostics Liver Disease Assessment because it offers a non-invasive way to diagnose liver conditions, which traditionally rely on liver biopsies—a more invasive and uncomfortable procedure. This diagnostic method uses advanced imaging and biomarker analysis, such as MRI-PDFF and FIB4, to accurately assess liver health and fibrosis levels. By potentially reducing the need for biopsies, this new approach aims to make diagnosing liver diseases like NAFLD and NASH more accessible and less burdensome for patients.

What evidence suggests that this diagnostic assay is effective for liver disease?

Research has shown that noninvasive tests can effectively check for liver fibrosis, the thickening and scarring of liver tissue. Blood tests and imaging scans accurately identify different stages of liver damage. Studies have found that these methods can predict long-term liver health. In this trial, the AGED Diagnostics Liver Disease Assessment will evaluate participants. For conditions like fatty liver and NASH (a severe form of fatty liver), these tests help distinguish between mild and advanced disease. Thus, the AGED Diagnostics Liver Disease Assessment can successfully identify and stage liver disease without requiring an invasive biopsy. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for people with liver disease, specifically those with non-alcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH), as well as healthy individuals. Participants will be involved in testing to help develop new ways to identify and differentiate between types of liver conditions.

Inclusion Criteria

Participant with liver biopsy over the past 1-2 years are permissible for study inclusion

My liver is healthy and I have no liver diseases.

I may have a condition like metabolic syndrome, liver disease, heart disease, or kidney disease.

Exclusion Criteria

I am unable to understand and give consent for treatment.

Participant is known to have HIV, Hepatitis B or Hepatitis C

Participant is known to be pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Test Method Verification

Conduct whole genome bisulfite sequencing in patient liver tissue and patient plasma to identify candidate biomarkers that can discriminate between steatosis and NASH, and stage liver fibrosis.

6-9 months

Biomarker Validation

Select top NASH specific biomarkers and top fibrosis specific biomarkers and design, develop and test probes to assess overall performance of each candidate biomarker in plasma through multiple targeted sequencing and PCR based modalities.

6-9 months

Follow-up

Participants are monitored for safety and effectiveness after biomarker validation

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AGED Diagnostics Liver Disease Assessment

Trial Overview The trial is testing the AGED Multiple Target Assay on different groups: those with fibrosis, NAFLD patients, and healthy controls. It aims to validate biomarkers that can distinguish between simple fat accumulation in the liver and NASH, and also stage fibrosis using blood samples.

How Is the Trial Designed?

Group I: NAFLD Experimental Treatment 1 Intervention

Diagnostic assessment. confirmation of diagnosis from liver biopsy is required. * NASH Diagnosis is on histological assessment from NASH CRN score: * NASH CRN score of ≤ 3 is classified as steatosis. * NASH CRN score of ≥ 5 is classified as NASH. * Participant samples can be subsequently diagnosed with CAP or MRI-PDFF to rule out NASH (or in rule in simple steatosis) but cannot be used to rule in NASH (as biopsy is required for confirmation). * All diagnostic criteria for participant at time of visit is requested.

Group II: Liver Fibrosis Experimental Treatment 1 Intervention

Diagnostic assessment, For fibrosis diagnosis and analysis, diagnostic tools can constitute zero or mild fibrosis (F0-F1), significant fibrosis (F2), and advanced fibrosis (F3-F4) in the presence or absence of NASH. * Participant samples can be diagnosed through non-invasive modalities such as but not limited to FIB4, ELF, PROC3, and/or imaging modalities such as but not limited to vibration controlled transient elastography (VCTE), magnetic resonance elastography (MRE), acoustic radiation force impulse (AFRI) or multiparameter imaging assessments. * All diagnostic criteria for participant at time of visit is requested.

Group III: Health controls Experimental Treatment 1 Intervention

Diagnostic assessment

Who Is Running the Clinical Trial?

Active Genomes Expressed Diagnostics, Corp

Lead Sponsor

Trials

1

Recruited

400+

Walter Reed National Military Medical Center

Collaborator

Trials

149

Recruited

33,800+

Arizona Clinical Trials

Collaborator

Trials

1

Recruited

400+

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK384744/

Cost-effectiveness analysis: diagnostic tests for NAFLD ... - NCBI In the majority of this evidence authors did not report QoL results per liver disease state (fibrosis, compensated cirrhosis, decompensated cirrhosis).

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468125325000974

Review Screening for advanced steatotic liver disease These tests are extensively validated as surrogates of liver fibrosis and importantly as predictors of long-term liver-related outcomes (table 1).

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2796089

Simulation of Long-term Outcomes in Patients with ... Compared with patients aged 40 years, 10-year liver-related mortality was lower in those aged 65 years across all fibrosis stages; however, 10- ...

4. cghjournal.org cghjournal.org/article/S1542-3565(23)00266-5/fulltext

Noninvasive Assessment of Liver Fibrosis in NAFLD Liver fibrosis severity is the strongest predictor of clinical outcomes. The emergence of effective therapeutics on the horizon highlights the ...

5. journals.lww.com journals.lww.com/hep/fulltext/2022/01000/population_screening_for_liver_fibrosis__toward.19.aspx

Population screening for liver fibrosis: Toward early... Recent studies have shown that liver fibrosis can be assessed with relatively high accuracy noninvasively by serological tests, transient elastography, and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4212151/

Liver Safety Assessment: Required Data Elements and Best ... Abstract. A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4212156/

Methodology to Assess Clinical Liver Safety Data - PMC This section summarizes current methods for systematic assessment of liver safety data, as discussed at the workshop, and provides respective recommendations.

8. clinconnect.io clinconnect.io/trials/NCT06348563

AGED Diagnostics Liver Disease Assessment - ClinConnect The AGED Diagnostics Liver Disease Assessment trial is researching how to better identify different types of liver diseases using blood tests.

9. fda.gov fda.gov/media/116737/download

Guidance for Industry Drug-Induced Liver Injury This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any ...

10. nature.com nature.com/articles/s41575-024-00936-x

Designing clinical trials to address alcohol use and ... However, the risk of advanced liver disease increases with alcohol consumption above 1 drink per day for women and 2 drinks per day for men. The ...