biostudies-literatureUnknown50Mahjoubin-Tehran M<h4>Objective</h4>The prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis (NAFLD/NASH) is increasing. NAFLD/NASH may progress to cirrhosis and hepatocellular carcinoma. However, most patients with NAFLD/NASH will die from a vascular cause. There are no approved pharmacological treatments for NASH/NAFLD. Many clinical trials have been, or are being, undertaken; however, the challenge is the assessment of the clinical endpoint. The main objective of this narrative review was to evaluate the efficacy of drugs used in clinical trials for the treatment of NAFLD/NASH that included a liver biopsy as the gold standard.<h4>Methods</h4>A literature search was conducted using 3 databases (PubMed, Scopus, and Google Scholar) to identify the clinical trials that included lMolecular metabolism101049https://www.ebi.ac.uk/biostudies/studies/S-EPMC8324680biostudies-literatureNon-alcoholic fatty liver disease and steatohepatitis: State of the art on effective therapeutics based on the gold standard method for diagnosis.PMC8324680De Vincentis AMikhailidis DPAtkin SLJamialahmadi TMahjoubin-Tehran MMantzoros CSSahebkar AfalseNon-alcoholic fatty liver disease and steatohepatitis: State of the art on effective therapeutics based on the gold standard method for diagnosis.<h4>Objective</h4>The prevalence of non-alcoholic fatty liver disease and non-alcoholic steatohepatitis (NAFLD/NASH) is increasing. NAFLD/NASH may progress to cirrhosis and hepatocellular carcinoma. However, most patients with NAFLD/NASH will die from a vascular cause. There are no approved pharmacological treatments for NASH/NAFLD. Many clinical trials have been, or are being, undertaken; however, the challenge is the assessment of the clinical endpoint. The main objective of this narrative review was to evaluate the efficacy of drugs used in clinical trials for the treatment of NAFLD/NASH that included a liver biopsy as the gold standard.<h4>Methods</h4>A literature search was conducted using 3 databases (PubMed, Scopus, and Google Scholar) to identify the clinical trials that included l2021-01-01T00:00:00Z2021 Aug2025-05-29T20:47:45.147Z2022-02-11T02:31:49.834ZS-EPMC83246803267379810.1016/j.molmet.2020.101049