Testing blood tests to detect liver inflammation and scarring in fatty liver disease
Compares new blood tests with liver biopsy in adults with suspected fatty liver disease.
Plain-language title generated from the registry record
Registry title: AGED Diagnostics Clinical Validation Study
Key facts
- Where
- Bethesda, United StatesSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07867574, who can take part
Where in United States
- AGED Diagnostics Central LabBethesda, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Active Genomes Expressed Diagnostics, Corp
- Trial code
- NCT07867574
- Record updated
- 9 October 2026
- Original description
Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis:Read full original descriptionShow less
AGED Diagnostics Clinical Research Study to Validate Liver Disease and Metabolic Associated Disease Biomarkers
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.
Inclusion: Patients must meet all the following inclusion criteria to be eligible for enrollment in the study:; Patient is between the ages of 18 and 75; Patient understands and is willing to sign a written informed consent form (ICF); Patient has been diagnosed with or is suspected of having MASLD, more specifically, either simple steatosis, metabolic dysfunction-associated steatohepatitis (MASH) or metabolic dysfunction and alcohol-associated liver disease (MetALD), or a confirmed or suspected diagnosis of liver fibrosis and are being evaluated for fibrosis stage; Patient has had or will have a diagnostic liver biopsy within 12 months (before or after) being enrolled in the study; The patient has either undergone PEth testing or a physician will complete the Investigator Confidence Assessment documenting alcohol consumption and the likelihood of MetALD.
Exclusion: Patient has had a liver transplant at any time; Patient has been enrolled in a therapeutic clinical trial and has been administered a therapeutic drug as part of that trial; Patient has or has had any form of liver cancer; Patient is known to have HIV, Hepatitis B or Hepatitis C; Patient is on anti-coagulation or anti-platelet therapy other than aspirin, e.g. Coumadin, Pradaxa, Plavix, or heparin; Patient is unable or unwilling to provide informed consent; Patient is on Rezdiffra (resmetirom); Patients who are currently undergoing dose escalation or who have initiated, discontinued, restarted, switched, or changed the dose of their GLP-1 receptor agonist.