Alcohol-associated liver disease (ALD) is a leading cause of preventable cirrhosis, hepatocellular carcinoma, and liver-related mortality, yet current laboratory and imaging tools detect only late-stage disease. This narrative review synthesizes emerging evidence on novel biomarkers that capture the multidimensional pathophysiology of ALD and discusses their utility for routine clinical practice. Traditional serum-based liver fibrosis markers (e.g., cytokeratin-18 fragments, Pro-C3, or the Enhanced Liver Fibrosis) improve non-invasive staging risk beyond aminotransferases, while elastography techniques, such as vibration-controlled transient elastography and magnetic resonance elastography, can also quantify liver stiffness with high precision. Among novel mechanistic biomarkers, genetic polymorphisms in PNPLA3, TM6SF2, MBOAT7, HSD17B13, and polygenic risk scores define lifetime risk, whereas sex-specific hormonal milieus also modify susceptibility and progression. Moreover, gut dysbiosis signatures, including reduced Faecalibacterium prausnitzii, Akkermansia muciniphila, and a lower Firmicutes/Bacteroidetes ratio, and their metabolites (short-chain fatty acids, bile acids, trimethylamine N-oxide) correlate with liver inflammation and fibrosis. Endocrine imbalances of cortisol, testosterone, and thyroid hormones further stratify metabolic vulnerability. Ultimately, multi-omics platforms (i.e., transcriptomics, lipidomics, proteomics, metabolomics, epigenomics) can reveal distinct molecular signatures that predict steatohepatitis, fibrogenesis, and early hepatocellular carcinoma. Integrating these biomarkers enables phase-specific enrichment strategies, earlier intervention windows, adaptive dose-finding, and mechanism-based endpoints in ALD trials. Remaining challenges include assay standardization, validation across diverse cohorts, and incorporation into regulatory frameworks. Future work could evaluate cost-effectiveness and feasibility in routine clinical practice. Widespread adoption promises earlier diagnosis, personalized risk reduction, and more efficient drug development for this globally prevalent disorder.
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Nonalcoholic fatty liver disease (NAFLD) is the most common cause of liver disease globally, and its prevalence is rapidly increasing. Nonalcoholic steatohepatitis (NASH), a progressive form of NAFLD, is characterized by hepatocellular injury, inflammation, and fibrosis. Patients with NASH or severe fibrosis should be treated according to international NAFLD guidelines. Currently, regulatory agencies have not approved any pharmaceutical treatment for NAFLD. Vitamin E and pioglitazone are efficacious for NASH resolution; however, their benefits must be weighed against the reported risks. In a phase 2 trial, a glucagon-like peptide-1 agonist commonly used for diabetes and obesity was found to improve liver histology in patients with NASH. Furthermore, therapeutic agents targeting NASH pathogenesis, including bile acid signaling, insulin resistance, and lipid metabolism, are in various phases of clinical development. In this article, we review the benefits and drawbacks of current pharmacotherapy and the efficacy of upcoming treatments for NASH.
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Jeong-Ju Yoo, Won Kim, Moon Young Kim, Dae Won Jun, Sang Gyune Kim, Jong-Eun Yeon, Jin Woo Lee, Yong Kyun Cho, Sang Hoon Park, Joo Hyun Sohn, On behalf of the Korean Association for the Study of the Liver (KASL)-Korea Nonalcoholic fatty liver Study Group (KNSG)
Clin Mol Hepatol 2019;25(1):1-11. Published online August 8, 2018
Nonalcoholic fatty liver disease (NAFLD), together with metabolic syndrome and obesity, has shown a rapid increase in prevalence worldwide and is emerging as a major cause of chronic liver disease and liver transplantation. Among the various phenotypes of NAFLD, nonalcoholic steatohepatitis (NASH) is highly likely to progress to development of end-stage liver disease and cardiometabolic disease, resulting in liver-related and non-liver–related mortality. Nonetheless, there is no standardized pharmacotherapy against NASH and many drugs are under development in ongoing clinical trials. To develop a successful anti-NASH drug, it is necessary to select an appropriate target population and treatment outcomes depending on whether the mode of action is anti-metabolic, anti-inflammatory or anti-fibrotic. Recently, innovative surrogate markers have been investigated to replace hard outcomes such as liver histology and mortality and reduce the clinical trial duration. Currently, several drugs with fast track designation are being tested in phase III clinical trials, and many other drugs have moved into phase II clinical trials. Both lean NAFLD and typical obese NAFLD have been extensively studied and genetic variants such as PNPLA3 and TM6SF2 have been identified as significant risk factors for lean NAFLD. In the near future, noninvasive biomarkers and effective targeted therapies for NASH and associated fibrosis are required to develop precision medicine and tailored therapy according to various phenotypes of NAFLD.
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DNA Methylation Patterns According to Fatty Liver Index and Longitudinal Changes from the Korean Genome and Epidemiology Study (KoGES) Young Kyung Ko, Hayeon Kim, Yoonseok Lee, Young-Sun Lee, Jeong-An Gim Current Issues in Molecular Biology.2022; 44(3): 1149. CrossRef
Cardiovascular Risk Is Elevated in Lean Subjects with Nonalcoholic Fatty Liver Disease Yuna Kim, Eugene Han, Jae Seung Lee, Hye Won Lee, Beom Kyung Kim, Mi Kyung Kim, Hye Soon Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Byung-Wan Lee, Eun Seok Kang, Bong-Soo Cha, Yong-ho Lee, Seung Up Kim Gut and Liver.2022; 16(2): 290. CrossRef
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Tenofovir alafenamide alleviates nonalcoholic steatohepatitis in mice by blocking the phosphorylation of AKT in intrahepatic mononuclear phagocytes Pu Reun Roh, Sung Min Kim, Byung-Yoon Kang, Kyoung Do Mun, Jong Geun Park, Min Woo Kang, Wonhee Hur, Ji Won Han, Heechul Nam, Seung Kew Yoon, Pil Soo Sung Biomedicine & Pharmacotherapy.2022; 156: 113952. CrossRef
Environmental exposure to organophosphate esters and suspected non-alcoholic fatty liver disease among US adults: A mixture analysis Haisheng Chai, Weiye Hu, Yaoyao Dai, Xiaohan Zhu, Ping'an Qian, Junfeng Zhu Frontiers in Public Health.2022;[Epub] CrossRef
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Association between depression and nonalcoholic fatty liver disease: Contributions of insulin resistance and inflammation Ju Won Lee, Seung Ha Park Journal of Affective Disorders.2021; 278: 259. CrossRef
Evolution of liver fibrosis and steatosis markers in patients with type 2 diabetes after metformin treatment for 2 years Hye Won Lee, Jae Seung Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Seung Up Kim Journal of Diabetes and its Complications.2021; 35(1): 107747. CrossRef
Updates in the quantitative assessment of liver fibrosis for nonalcoholic fatty liver disease: Histological perspective Gwyneth Soon, Aileen Wee Clinical and Molecular Hepatology.2021; 27(1): 44. CrossRef
Association between the severity of liver fibrosis and cardiovascular outcomes in patients with type 2 diabetes Ho Soo Chun, Jae Seung Lee, Hye Won Lee, Beom Kyung Kim, Jun Yong Park, Do Young Kim, Sang Hoon Ahn, Yong‐Ho Lee, Young Dae Kim, Seung Up Kim Journal of Gastroenterology and Hepatology.2021; 36(6): 1703. CrossRef
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Body weight variability and the risk of cardiovascular outcomes in patients with nonalcoholic fatty liver disease Mi Na Kim, Kyungdo Han, Juhwan Yoo, Yeonjung Ha, Young Eun Chon, Ju Ho Lee, Tracey G. Simon, Andrew T. Chan, Seong Gyu Hwang Scientific Reports.2021;[Epub] CrossRef
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Association of Skeletal Muscle and Adipose Tissue Distribution with Histologic Severity of Non-Alcoholic Fatty Liver Min-Kyu Kang, Jung-Hun Baek, Young-Oh Kweon, Won-Young Tak, Se-Young Jang, Yu-Rim Lee, Keun Hur, Gyeonghwa Kim, Hye-Won Lee, Man-Hoon Han, Joon-Hyuk Choi, Soo-Young Park, Jung-Gil Park Diagnostics.2021; 11(6): 1061. CrossRef
Circulating miRNA is a useful diagnostic biomarker for nonalcoholic steatohepatitis in nonalcoholic fatty liver disease Tae Hyung Kim, Yoonseok Lee, Young-Sun Lee, Jeong-An Gim, Eunjung Ko, Sun Young Yim, Young Kul Jung, SeongHee Kang, Moon Young Kim, Hayeon Kim, Baek-hui Kim, Ji Hoon Kim, Yeon Seok Seo, Hyung Joon Yim, Jong Eun Yeon, Soon Ho Um, Kwan Soo Byun Scientific Reports.2021;[Epub] CrossRef
Inhaled exposure to air fresheners aggravated liver injury in a murine model of nonalcoholic fatty acid liver disease Sanghwa Kim, Ah Young Lee, Myung-Haing Cho Heliyon.2021; 7(3): e06452. CrossRef
Low Skeletal Muscle Mass Is a Risk Factor for Subclinical Atherosclerosis in Patients with Nonalcoholic Fatty Liver Disease Min-Kyu Kang, Jung-Gil Park Diagnostics.2021; 11(5): 854. CrossRef
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Trends in the prevalence of chronic liver disease in the Korean adult population, 1998–2017 Seung Ha Park, Lindsay D. Plank, Ki Tae Suk, Yong Eun Park, Jin Lee, Joon Hyuk Choi, Nae Yun Heo, Jongha Park, Tae Oh Kim, Young Soo Moon, Hyun Kuk Kim, Hang Jea Jang, Ha Young Park, Dong Joon Kim Clinical and Molecular Hepatology.2020; 26(2): 209. CrossRef
Liver involvement in patients with Gaucher disease types I and III Rodrigo Tzovenos Starosta, Filippo Pinto e Vairo, Alícia Dorneles Dornelles, Suélen Porto Basgalupp, Marina Siebert, Maria Lúcia Alves Pedroso, Carlos Thadeu Schmidt Cerski, Mário Reis Álvares-da-Silva, Ida Vanessa Doederlein Schwartz Molecular Genetics and Metabolism Reports.2020; 22: 100564. CrossRef
Association of grip strength with non-alcoholic fatty liver disease: investigation of the roles of insulin resistance and inflammation as mediators Seung Ha Park, Dong Joon Kim, Lindsay D. Plank European Journal of Clinical Nutrition.2020; 74(10): 1401. CrossRef
Analysis of the dietary factors associated with suspected pediatric nonalcoholic fatty liver disease and potential liver fibrosis: Korean National Health and Nutrition Examination Survey 2014-2017 Mi Jin Kim, Kyung Jae Lee BMC Pediatrics.2020;[Epub] CrossRef
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Obesity and nonalcoholic fatty liver disease: From pathophysiology to therapeutics Stergios A. Polyzos, Jannis Kountouras, Christos S. Mantzoros Metabolism.2019; 92: 82. CrossRef
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