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Numerous candidate drugs are being evaluated for the treatment of nonalcoholic fatty liver disease (NAFLD), including some for the treatment of nonalcoholic steatohepatitis (NASH). One of these is saroglitazar, a dual peroxisome-proliferator–activated receptor (PPAR) alpha/gamma agonist that is currently approved in India for the treatment of NASH. Now, researchers have conducted a proof-of-concept study of this agent in a Western population.
In this multicenter, double-blind, phase 2 study, 16 patients with biopsy-proven NASH were randomized to receive saroglitazar 2 mg (n=6) or 4 mg (n=7) or placebo (n=3) daily. There was an initial 4-week screening period, followed by 24 weeks of treatment, and a safety follow-up visit 4 weeks after treat…