NCT07867574Not yet recruiting
AGED Diagnostics Clinical Validation Study
AGED Diagnostics Clinical Research Study to Validate Liver Disease and Metabolic Associated Disease Biomarkers
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 500 (estimated)
- First submitted
- 27 Sept 2026
- Start date
- Oct 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Active Genomes Expressed Diagnostics, Corp
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT07867574
What you commit to
- Study type: Observational
- Planned participants: 500
- From Oct 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Patient has or has had any form of liver cancer.
- Patient is known to have HIV, Hepatitis B or Hepatitis C.
Lab values
- Patient is on anti-coagulation or anti-platelet therapy other than aspirin, e.g. Coumadin, Pradaxa, Plavix, or heparin.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AGED Diagnostics Central Lab Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.