An observational study in MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease) and Fibrosis and Cirrhosis of Liver, sponsored by Active Genomes Expressed Diagnostics, Corp. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Active Genomes Expressed Diagnostics, Corp · Observational
Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis:
This study aims to validate two investigational blood tests developed by AGED Diagnostics for the detection of metabolic dysfunction-associated steatohepatitis (MASH) and the assessment of liver fibrosis (scarring). MASH is a progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD) that can lead to advanced liver disease, cirrhosis and liver-related complications.
This prospective, observational study will enroll approximately 400-500 patients with suspected MASLD who are undergoing liver biopsy as part of their clinical care. Researchers will collect blood samples and relevant medical information from participants at multiple clinical sites. The blood samples will be analyzed using advanced DNA sequencing technology to measure DNA methylation, a biological marker that may provide information about liver health.
The study will evaluate how accurately the investigational blood tests distinguish MASH from simple steatosis (fat accumulation in the liver without MASH) and identify different stages of liver fibrosis. Blood test results will be compared with liver biopsy findings.
The results will be used to select and validate the most accurate prediction models for future clinical utility studies. The long-term goal is to develop noninvasive blood tests that may help healthcare providers identify patients with MASH and liver fibrosis earlier and guide appropriate clinical care.
Study Overview:
This multicenter, prospective, observational study is designed to validate investigational blood-based diagnostic tests developed by AGED Diagnostics for the detection of metabolic dysfunction-associated steatohepatitis (MASH) and the staging of liver fibrosis.
MASH is a progressive form of metabolic dysfunction-associated steatotic liver disease (MASLD) characterized by fat accumulation, inflammation and injury to liver cells. Over time, MASH can lead to liver fibrosis, cirrhosis and serious liver-related complications. Early identification of MASH and accurate assessment of liver fibrosis are important for determining appropriate clinical management.
Current methods for definitively diagnosing MASH generally rely on liver biopsy, an invasive procedure that is not practical for widespread screening or routine disease monitoring. AGED Diagnostics is developing blood-based tests that analyze circulating cell-free DNA (cfDNA) DNA methylation patterns to identify biological signals associated with MASH and different stages of liver fibrosis.
Study Objectives:
The primary objective of this study is to independently validate candidate diagnostic prediction models developed during an earlier Verification Study. The study will assess the ability of these models to distinguish patients with simple steatosis from those with MASH and to classify liver fibrosis across stages F0 through F4, ranging from no fibrosis to cirrhosis.
A second objective is to identify the best-performing prediction model for each investigational blood test. The selected models will undergo further evaluation in a subsequent Clinical Utility Study to determine how the tests may support clinical decision-making and improve patient care.
The investigational tests are being developed with a target overall diagnostic accuracy of at least 90%. This is a development objective and does not represent established clinical performance.
Study Population and Design:
Approximately 400-500 participants with suspected MASLD will be enrolled across multiple clinical research sites. Eligible participants will have undergone or be scheduled to undergo a liver biopsy as part of their routine clinical evaluation, in accordance with the study's eligibility criteria.
All participants will be independent of those enrolled in AGED's previous studies.
Participants will be categorized according to their clinical and liver biopsy findings, including simple steatosis, MASH and relevant additional subgroups. Participants will also be classified according to their stage of liver fibrosis, from F0 to F4. A subset of participants may have metabolic dysfunction and alcohol-associated liver disease (MetALD).
The study is observational. Blood samples and relevant clinical information will be collected for research purposes. The investigational blood tests will not be used to direct participants' clinical care during this study.
Blood Sample Collection and Analysis:
Blood samples will be collected by trained healthcare professionals using standard venipuncture and study-provided collection kits. Samples will be transported to AGED Diagnostics' central laboratory for processing and analysis.
Researchers will isolate plasma and extract circulating cell-free DNA from the collected blood samples. The DNA will be analyzed using advanced sequencing technology capable of detecting DNA methylation patterns associated with liver disease.
DNA methylation is a naturally occurring chemical modification of DNA that can provide information about the tissues from which circulating DNA originates and their biological state. AGED's investigational tests use selected DNA methylation biomarkers and computational prediction models to identify patterns associated with MASH and different stages of liver fibrosis.
Laboratory processing and data analysis will follow standardized procedures and quality control requirements to support the reliability and consistency of the results.
Relevant demographic information, medical history, laboratory findings and liver biopsy results will be collected through secure electronic case report forms.
Study Procedures and Analysis:
The study will be conducted in two principal stages.
Stage 1: An interim analysis will be conducted after approximately half of the participants' blood samples have been processed and sequenced. Candidate prediction models will be evaluated for their ability to distinguish simple steatosis from MASH and classify liver fibrosis severity (F0-F4). Based on diagnostic performance, one or two models for each investigational test will be selected for further evaluation, with limited optimization if necessary.
Stage 2: The selected models will be evaluated using the remaining participants as an independent validation cohort, with predictions compared against liver biopsy findings. A subsequent analysis of the entire study population will assess overall diagnostic performance across relevant clinical subgroups. Laboratory personnel and the primary analysis team will remain blinded to clinical diagnoses and cohort assignments until the relevant analyses are completed.
Expected Outcomes and Future Research:
The study will assess the diagnostic performance of AGED's investigational blood tests for identifying MASH and determining the stage of liver fibrosis. The findings will support the selection of final prediction models for further clinical development.
The selected tests are intended to undergo subsequent clinical utility evaluation to determine whether blood-based diagnosis of MASH and liver fibrosis can improve clinical decision-making, facilitate earlier identification of patients with progressive liver disease and reduce reliance on invasive diagnostic procedures.
This study is intended to evaluate diagnostic performance and will not assess the effectiveness of a treatment or use investigational test results to guide clinical care.
1,270 studies on the registry are indexed under Fibrosis; 276 are open to participants now.
This study's planned enrollment of 500 is above the median of 157 across 386 observational studies indexed under Fibrosis.
Browse Fibrosis studies →Active Genomes Expressed Diagnostics, Corp is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study will enroll \~425 adults with suspected metabolic dysfunction-associated steatotic liver disease (MASLD) who have undergone or are scheduled to undergo a liver biopsy as part of their routine clinical care. Participants will represent a range of disease severity, including simple steatosis, metabolic dysfunction-associated steatohepatitis (MASH), and liver fibrosis stages F0-F4. The study population will include approximately 100 participants with simple steatosis and 325 participants with MASH across varying stages of fibrosis. A subset may have metabolic dysfunction and alcohol-associated liver disease (MetALD). All participants will be independent of those enrolled in previous AGED Diagnostics studies.
Inclusion Criteria for MASLD \& Fibrosis Patients
Patients must meet all the following inclusion criteria to be eligible for enrollment in the study:
Exclusion Criteria. Patients with any of the following exclusion criteria are not eligible for enrollment in the study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* NASH CRN ≤3 * Fibrosis stage F0-F1
* NASH CRN 4-8 * Fibrosis stage F0-F1
* NASH CRN 4-8 * Fibrosis stage F2
* NASH CRN 4-8 * Fibrosis stage F3
* NASH CRN 4-8 * Fibrosis stage F4 (cirrhosis)
Diagnostic Accuracy of the Blood-Based MASH Prediction Model
The diagnostic performance of the investigational blood-based MASH prediction model will be evaluated by comparing predicted classifications of MASH and simple steatosis with liver biopsy findings. Performance will be assessed using overall diagnostic accuracy, sensitivity, specificity and area under the receiver operating characteristic curve (AUROC) in an independent validation cohort.
Time frame: From blood sample collection through completion of the independent validation analysis (approximately 12 months)
Diagnostic Accuracy of the Blood-Based Liver Fibrosis Prediction Model
The diagnostic performance of the investigational blood-based liver fibrosis prediction model will be evaluated by comparing predicted fibrosis stages with liver biopsy findings. Performance will be assessed using overall staging accuracy and the ability to distinguish minimal fibrosis (F0-F1), moderate fibrosis (F2), advanced fibrosis (F3) and cirrhosis (F4) in an independent validation cohort.
Time frame: From blood sample collection through completion of the independent validation analysis (approximately 12 months).
Plan to share: Undecided — De-identified individual participant data (IPD) underlying the published study results may be shared with qualified researchers upon reasonable request and approval by AGED Diagnostics and be reviewed on a case by case basis. Shared data may include relevant demographic and clinical characteristics, liver biopsy findings, fibrosis staging, and investigational diagnostic test results. Data sharing will be subject to applicable privacy regulations, participant consent, institutional review requirements, and appropriate data use agreements. Proprietary assay methodologies, algorithms, and commercially sensitive information will not be disclosed.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.
Of 186 observational studies under Fibrosis, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 105. This study's planned 14 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Active Genomes Expressed Diagnostics, Corp