Saroglitazar, a PPAR-α/γ Agonist, for Treatment of NAFLD: A Randomized Controlled Double-Blind Phase 2 Trial.
Adipose Tissue
/ diagnostic imaging
Adult
Alanine Transaminase
/ blood
Alkaline Phosphatase
/ blood
Aspartate Aminotransferases
/ blood
Cholesterol
/ blood
Cholesterol, HDL
/ blood
Cholesterol, LDL
/ blood
Cholesterol, VLDL
/ blood
Double-Blind Method
Elasticity Imaging Techniques
Female
Humans
Insulin Resistance
Liver
/ diagnostic imaging
Magnetic Resonance Imaging
Male
Middle Aged
Non-alcoholic Fatty Liver Disease
/ blood
PPAR alpha
/ agonists
PPAR gamma
/ agonists
Phenylpropionates
/ therapeutic use
Pyrroles
/ therapeutic use
Triglycerides
/ blood
gamma-Glutamyltransferase
/ blood
Journal
Hepatology (Baltimore, Md.)
ISSN: 1527-3350
Titre abrégé: Hepatology
Pays: United States
ID NLM: 8302946
Informations de publication
Date de publication:
10 2021
10 2021
Historique:
revised:
22
03
2021
received:
10
08
2020
accepted:
25
03
2021
pubmed:
4
4
2021
medline:
11
1
2022
entrez:
3
4
2021
Statut:
ppublish
Résumé
NAFLD is characterized by insulin resistance and dysregulated lipid and glucose metabolism. Saroglitazar, a dual peroxisome proliferator activated receptor-α/γ agonist, improves insulin sensitivity, and lipid and glycemic parameters. Saroglitazar improved 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 alanine aminotransferase (ALT) ≥ 50 U/L at baseline and body mass index ≥25 kg/m Saroglitazar 4 mg significantly improved ALT, LFC, insulin resistance, and atherogenic dyslipidemia in participants with NAFLD/NASH. (ClinicalTrials.gov identifier: NCT03061721.).
Sections du résumé
BACKGROUND AND AIMS
NAFLD is characterized by insulin resistance and dysregulated lipid and glucose metabolism. Saroglitazar, a dual peroxisome proliferator activated receptor-α/γ agonist, improves insulin sensitivity, and lipid and glycemic parameters. Saroglitazar improved NASH histology in animal studies. In this randomized controlled clinical trial, we evaluated the efficacy and safety of saroglitazar in patients with NAFLD/NASH.
APPROACH AND RESULTS
A total of 106 patients with NAFLD/NASH with alanine aminotransferase (ALT) ≥ 50 U/L at baseline and body mass index ≥25 kg/m
CONCLUSIONS
Saroglitazar 4 mg significantly improved ALT, LFC, insulin resistance, and atherogenic dyslipidemia in participants with NAFLD/NASH. (ClinicalTrials.gov identifier: NCT03061721.).
Substances chimiques
Cholesterol, HDL
0
Cholesterol, LDL
0
Cholesterol, VLDL
0
PPAR alpha
0
PPAR gamma
0
Phenylpropionates
0
Pyrroles
0
Triglycerides
0
Cholesterol
97C5T2UQ7J
saroglitazar
E0YMX3S4JD
gamma-Glutamyltransferase
EC 2.3.2.2
Aspartate Aminotransferases
EC 2.6.1.1
Alanine Transaminase
EC 2.6.1.2
Alkaline Phosphatase
EC 3.1.3.1
Banques de données
ClinicalTrials.gov
['NCT03061721']
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1809-1824Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
© 2021 by the American Association for the Study of Liver Diseases.
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