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Cited by 96Liver Disease Diagnosis and TreatmentLiver Diseases and ImmunityDrug-Induced Hepatotoxicity and Protection

The DOI matches its Crossref record.

A Phase 2 Double Blinded, Randomized Controlled Trial of Saroglitazar in Patients With Nonalcoholic Steatohepatitis

Siddiqui, Mohammad Shadab, Idowu, Michael O., Parmar, Deven, Borg, Brian B., Denham, Douglas, Loo, Nicole M., Lazas, Donald, Younes, Ziad, Sanyal, Arun J.·2021·Clinical Gastroenterology and Hepatology
DOI 10.1016/j.cgh.2020.10.051
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Abstract

Nonalcoholic steatohepatitis (NASH), the clinically aggressive variant of nonalcoholic fatty liver disease, is characterized by hepatocellular injury and inflammation. 1 Patients with NASH are at higher risk of progression to cirrhosis and it is therefore targeted for drug development efforts. 2 Lifestyle modifications and weight loss are the only recommended modalities and no drug is yet approved for the treatment of patients with NASH. Saroglitazar is a dual PPAR α/γ agonist, which has shown promise for treatment of nonalcoholic fatty liver disease. 3 Because of its combined PPAR-α/γ agonism, it has a clinically favorable impact of glucose and lipid metabolism. Saroglitazar has shown to improve liver-related histology in patients with NASH and was recently approved for treatment of NASH in India. 4 The current study builds on the published literature in this proof of concept study to determine if there is a signal for histologic improvement of NASH with saroglitazar in a Western population.

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Crossref · 10.1016/j.cgh.2020.10.051

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Research works printed but not linked: 5

  1. Kleiner, 2005, Design and validation of a histological scoring system for nonalcoholic fatty liver disease, Hepatology, 41, 1313, 10.1002/hep.20701 · DOI · Paper page
  2. Shadab Siddiqui, 2018, Case definitions for inclusion and analysis of endpoints in clinical trials for NASH through the lens of regulatory science, Hepatology, 67, 2001, 10.1002/hep.29607 · DOI
  3. Joshi, 2015, Saroglitazar for the treatment of dyslipidemia in diabetic patients, Expert Opin Pharmacother, 16, 597, 10.1517/14656566.2015.1009894 · DOI
  4. Kaul, 2019, New dual peroxisome proliferator activated receptor agonist - Saroglitazar in diabetic dyslipidemia and non-alcoholic fatty liver disease: integrated analysis of the real world evidence, Cardiovasc Diabetol, 18, 10.1186/s12933-019-0884-3 · DOI
  5. Siddiqui, 2015, Severity of nonalcoholic fatty liver disease and progression to cirrhosis associate with atherogenic lipoprotein profile, Clin Gastroenterol Hepatol, 13, 1000, 10.1016/j.cgh.2014.10.008 · DOI

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Metadata

Authors
Siddiqui, M. S., Idowu, M. O., Parmar, D., Borg, B. B., Denham, D., Loo, N. M., Lazas, D., Younes, Z., & Sanyal, A. J.
Affiliations
  • Virginia Commonwealth University (US)
  • Clinical Trials of Texas (US)
  • Texas Liver Institute (US)
  • Gastro One (United States) (US)
Corresponding author
Siddiqui, Mohammad Shadab
ORCID
Venue
Clinical Gastroenterology and Hepatology
Publisher
Elsevier BV
Published
2021-12
Volume
19
Issue
12
Pages
2670-2672
ISSN
1542-3565 (ISSN-L)
DOI
10.1016/j.cgh.2020.10.051
OpenAlex
W3096860088
Cited by
96
References
0
Citations by year
2026: 12 · 2025: 21 · 2024: 18 · 2023: 22 · 2022: 14 · 2021: 9
FWCI
5.51
Type
journal article
Language
en
Open access
closed
Licence
Locations
  • Clinical Gastroenterology and Hepatology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Bristol-Myers Squibb
  • Novo Nordisk
  • Merck
  • Shire
  • Novartis
  • Gilead Sciences
  • Novartis Pharmaceuticals Corporation
  • AbbVie
Topics
  • Health Sciences › Medicine › Hepatology › Liver Disease Diagnosis and Treatment
  • Health Sciences › Medicine › Hepatology › Liver Diseases and Immunity
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Drug-Induced Hepatotoxicity and Protection
Keywords
saroglitazar, nonalcoholic steatohepatitis, non-alcoholic fatty liver disease, PPAR alpha/gamma agonist, histologic improvement, liver histopathology, Western populations
MeSH terms
Humans, Liver, Phenylpropionates, Pyrroles, PPAR alpha, Non-alcoholic Fatty Liver Disease

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