AGED Diagnostics Clinical Validation Study

NCT07867574 · tracked via the Priya Life Science USA tracker

Sponsor

Active Genomes Expressed Diagnostics, Corp

Phase

Observational

Started

2026-10-15

Last updated

2026-10-09

Condition(s) studied

MASH - Metabolic Dysfunction-Associated SteatohepatitisMASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)Fibrosis and Cirrhosis of LiverMetALD

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria for MASLD \& Fibrosis Patients Patients must meet all the following inclusion criteria to be eligible for enrollment in the study: 1. Patient is between the ages of 18 and 75. 2. Patient understands and is willing to sign a written informed consent form (ICF). 3. 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 4. Patient has had or will have a diagnostic liver biopsy within 12 months (before or after) being enrolled in the study. 5. 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 Criteria. Patients with any of the following exclusion criteria are not eligible for enrollment in the study: 1. Patient is unable or unwilling to provide informed consent. 2. Patient has or has had any form of liver cancer. 3. Patient is known to have HIV, Hepatitis B or Hepatitis C. 4. Patient has had a liver transplant at any time. 5. Patient is on anti-coagulation or anti-platelet therapy other than aspirin, e.g. Coumadin, Pradaxa, Plavix, or heparin. 6. Patient has been enrolled in a therapeutic clinical trial and has been administered a therapeutic drug as part of that trial. 7. Patient is on Rezdiffra (resmetirom). 8. Patients who are currently undergoing dose escalation or who have initiated, discontinued, restarted, switched, or changed the dose of their GLP-1 receptor agonist.

Primary outcome measure(s)

Diagnostic Accuracy of the Blood-Based MASH Prediction Model — From blood sample collection through completion of the independent validation analysis (approximately 12 months)
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.
Diagnostic Accuracy of the Blood-Based Liver Fibrosis Prediction Model — From blood sample collection through completion of the independent validation analysis (approximately 12 months).
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.

Trial sites (1)

Facility	City	Region	Status
AGED Diagnostics Central Lab	Bethesda	Maryland

Other trials for the same condition

Rezdiffra Pregnancy and Lactation Registry Recruiting

Rezdiffra® With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and F2-F3 Fibrosis Recruiting

Study of Resmetirom in Children and Adolescents With MASH Recruiting

A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH Recruiting

A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH) Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07867574 on ClinicalTrials.gov ↗ ← All trials in the USA