Department of Gastroenterology, Zydus Research Centre, Cadila Healthcare Ltd, Ahmedabad, India
Research Article
Effectiveness of the PPAR Agonist Saroglitazar in Nonalcoholic Steatohepatitis: Positive Data from Preclinical and Clinical Studies
Author(s): Manjunath Krishnappa*, Sunil Sharma, Payal Jain, Purav Trivedi, Deven Parmar and Pankaj Patel
Background: Saroglitazar, a novel Peroxisome Proliferator-Activated Receptor (PPAR) α/γ agonist, was evaluated in preclinical and clinical studies to evaluate its effectiveness in
NASH.
Methods: Preclinical studies included: (a) Choline Deficient L-amino Acid-defined High Fat Diet (CDAHFD) murine NASH model; (b) Long Evans and Wistar rats model for hepatotropic
activity; (c) DIAMOND™ NASH mice model. Clinical studies included: Phase 2 and Phase 3 studies in patients with biopsy proven NASH in India.
Results: In CDAHFD murine NASH model, Saroglitazar improved aspartate aminotransferase (AST), Alanine Aminotransferase (ALT) and prevented hepatocellular steatosis,
hepatocyte ballooning and lobular inflammation. In Long Evans and Wistarrats model, Saroglitazar was found to be hepatotropic. In the.. Read More»
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