An observational study in Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH), sponsored by Humanity and Health Research Centre. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Humanity and Health Research Centre · Observational
This is a 10-year, longitudinal, observational study of patients with NAFLD/NASH designed to specifically address important clinical questions that remain incompletely answered from registration trials. In addition to the study database, the biospecimen repository will also be included so that translational studies of genomics and biomarkers of response may be performed.
Non-alcoholic fatty liver disease (NAFLD) is an excess accumulation of fat in the liver cells. It is associated with obesity, high blood pressure, high cholesterol, and diabetes. Some people with NAFLD only have excess fat in the liver. However, other people may develop a worse form of NAFLD with liver injury and scarring. This form, called non-alcoholic steatohepatitis (NASH), can lead to liver failure, liver cancer, and death. Not much is known about why some people develop NASH and others do not.
This study aims to determine and elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications in Chinese subjects.
Subjects (BMI ≥ 25 kg/m2) with proven NAFL/NASH either by imaging (using MRI) or histology, referred to secondary or tertiary care for liver related problems will be asked to participate in this study.
Exclusion Criteria:
Prevalence of NAFL/NASH in Chinese
Determine the prevalence of NAFLD/NASH in military beneficiaries ages 18 or above. This will be determined by the % of subjects determined to have NAFLD/NASH in Chinese subjects.
Time frame: up to 10 years
Live imaging analysis
Transient elastography (FibroScan) and/or MR elastography will provide a measurement of liver stiffness. The liver stiffness metrics will be tabulated for each of the three time points and assessed for change.
Time frame: up to 10 years
Exploration, identification and validation of the circulating biomarkers for prediction and diagnosis of NAFL/NASH in Chinese
Cytokeratin-18 (CK-18), fibrosis-4 (FIB-4), leptin, adiponectin, TNF-alpha, PAI-1, IL-6, MCP-1, retinoids and other potential biomarkers will be determined and analysed.
Time frame: up to 10 years
Liver histology analysis
Liver histology (derived from central reading of liver biopsy at entry, standard of care biopsy done during screening or follow-up) will be examined and scored.
Time frame: up to 10 years
Plan to share: No
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Non-alcoholic Fatty Liver Disease→
Humanity and Health Research Centre