FSaroglitazar improves nonalcoholic fatty liver disease and metabolic health in liver transplant recipients.Nonalcoholic fatty liver disease (NAFLD) is common after liver transplantation (LT) and associated with increased metabolic burden.  Currently, there are is a paucity of investigations into treatment of post-LT NAFLD.  In the present study, we evaluated the safety and efficacy of saroglitazar, a novel dual PPAR α/γ agonist, on treatment of post-LT NAFLD and metabolic burden.


 This is phase 2A, single-center, open label, single arm study in which patients with post-LT NAFLD received saroglitazar magnesium 4 mg daily for 24 weeks.  NAFLD was defined by controlled attenuation parameter ≥264B/m.  The primary endpoint was reduction in liver fat as measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).  Secondary MRI based metabolic endpoints included visceral adipose tissue (VAT), abdominal subcutaneous adipose tissue volumes (ASAT), muscle fat infiltration (MFI) and fat free muscle volume (FFMV).


 Saroglitazar treatment led to reduction in MRI PDFF from 10.3±10.5% at baseline to 8.1±7.6%.  A relative 30% reduction from baseline MRI PDFF value was noted in 47% of all patients and in 63% of patients with baseline MRI PDFF >5%.  Reduction in serum alkaline phosphatase was an independent predictor MRI PDFF response.  Saroglitazar did not decrease FFMV nor increase MFI but did lead to mild increase in VAT and ASAT.  The study drug was well tolerated and mild non-significant increase in serum creatinine was noted.  Saroglitazar did not affect weight.


 DISCUSSION
 The study provides preliminary data demonstrating safety and metabolic benefits of saroglitazar in LT recipients and underscore the importance of future studies to establish its efficacy post-LT.
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