| ISSN |
1948-5182 (online) |
| Open Access |
This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/ |
| Copyright |
© The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved. |
| Article Reprints |
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| Permissions |
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| Publisher |
Baishideng Publishing Group Inc, 7041 Koll Center Parkway, Suite 160, Pleasanton, CA 94566, USA |
| Website |
http://www.wjgnet.com |
| Category |
Gastroenterology & Hepatology |
| Manuscript Type |
Clinical Trials Study |
| Article Title |
Phase III, multicenter, randomized, double-blind, placebo-controlled study of norursodeoxycholic acid in metabolic dysfunction-associated steatotic liver disease patients
|
| Manuscript Source |
Unsolicited Manuscript |
| All Author List |
Veerendra Kumar Panuganti, Chandrasekhar Varma Alluri, Javeed Mohammad, Mamatha Reddy Dundigalla, Pavan Kumar Madala, Sanyasirao KSSVV and Althaf Shaik |
| ORCID |
|
| Funding Agency and Grant Number |
| Funding Agency |
Grant Number |
| Shilpa Medicare Limited, Hyderabad, Telangana, India |
|
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| Corresponding Author |
Veerendra Kumar Panuganti, Head, PhD, Clinical Affair Division, Shilpa Medicare Limited, Unit VII, Plot No. 79, Survey No. 125, IDA, Mallapur, Nacharam, Hyderabad 500076, Telangāna, India. veerendrap.frd@shilpamedicare.com |
| Key Words |
24-norursodeoxycholic acid; Fatty liver; Liver diseases; Steatosis; Fibrosis; Metabolic dysfunction-associated steatotic liver disease; Nonalcoholic fatty liver disease |
| Core Tip |
This phase III trial demonstrated that norursodeoxycholic acid (norUDCA) 1500 mg significantly improved liver function in metabolic dysfunction-associated steatotic liver disease patients, with a majority of patients achieving alanine aminotransferase normalization and showing fibrosis regression on FibroScan. Notably norUDCA demonstrated favorable safety profile with no serious adverse events (SAEs) reported. All adverse events (AEs) reported were mild or moderate in intensity and recovered over time. These findings highlight the norUDCA’s efficacy and safety addressing the need for more approved promising therapies in managing metabolic dysfunction-associated steatotic liver disease. This phase III trial demonstrated that norursodeoxycholic acid (norUDCA) 1500 mg significantly improved liver function in metabolic dysfunction-associated steatotic liver disease patients, with a majority of patients achieving alanine aminotransferase normalization and showing fibrosis regression on FibroScan. Notably norUDCA demonstrated favorable safety profile with no serious adverse events (SAEs) reported. All adverse events (AEs) reported were mild or moderate in intensity and recovered over time. These findings highlight the norUDCA’s efficacy and safety addressing the need for more approved promising therapies in managing metabolic dysfunction-associated steatotic liver disease. |
| Publish Date |
2025-12-26 10:27 |
| Citation |
Panuganti VK, Alluri CV, Mohammad J, Dundigalla MR, Madala PK, KSSVV S, Shaik A. Phase III, multicenter, randomized, double-blind, placebo-controlled study of norursodeoxycholic acid in metabolic dysfunction-associated steatotic liver disease patients. World J Hepatol 2025; 17(12): 113658 |
| URL |
https://www.wjgnet.com/1948-5182/full/v17/i12/113658.htm |
| DOI |
https://dx.doi.org/10.4254/wjh.v17.i12.113658 |
