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Non-alcoholic fatty liver disease (NAFLD) is characterized by insulin resistance and dysregulated lipid and glucose metabolism. Saroglitazar, a novel dual peroxisome proliferator activated receptor-α/γ agonist, improves insulin sensitivity, and lipid and glycemic parameters. Saroglitazar improved nonalcoholic steatohepatitis (NASH) histology in animal studies. In this randomized controlled clinical trial, we evaluated the efficacy and safety of saroglitazar in patients with NAFLD/NASH. A total of 106 patients with NAFLD/NASH with ALT ≥