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Characteristics of contemporary drug clinical trials regarding the treatment of non-alcoholic steatohepatitis

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机构: [1]Department of Pharmacy, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing Engineering Research Center [2]Department of Physiology, The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, MD9-04-11, 2 Medical Drive, Singapore, 117593, Singapore [3]Drug and medical device clinical trial institution/Department of pharmacy, China Emergency General Hospital, Beijing, 100028, China [4]Duke-NUS Medical School, 8 College Road, Singapore, 169857, Singapore [5]Biomedical Sciences Industry Partnership Office (BMSIPO), A*STAR, 31 Biopolis Way, 138669, Singapore [6]CAMP, Singapore-MIT Alliance for Research and Technology, 1 CREATE Way, Level 4 Enterprise Wing, Singapore, 138602, Singapore [7]Mechanobiology Institute, National University of Singapore, T-Lab, #05-01, 5A Engineering Drive 1, Singapore, 117411, Singapore
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关键词: Non-alcoholic fatty liver disease Non-alcoholic steatohepatitis NASH Drug clinical trial Drug repurposing

摘要:
Non-alcoholic steatohepatitis (NASH), a chronic liver disease, has no United States Food and Drug Administration (FDA) approved drugs for treatment.To examine fundamental characteristics of drug clinical trials for NASH treatment on the global clinical trials registry platform.Cross-sectional analysis of clinical trials with NASH as medical condition that are registered on ClinicalTrials.gov. Relevant trial entries registered before and on October 7th, 2022, were downloaded, deduplicated, and reviewed. NCT numbers, titles, locations, funder types, statuses, durations, study designs, subject information, conditions, interventions, outcome measures were extracted and analyzed.Overall, 268 drug clinical trials were included in this study. Majority of the trials are conducted in United States (42.2 %). Most of the trials are funded by industry (67.9 %). The earliest initiated trials date back to 2001. Most trials are phase 2 (56.3 %), randomized (84.0 %), parallel assignment (78.7 %), and quadruple blind (40.3 %). The most concerned combined medical conditions are non-alcoholic fatty liver disease (NAFLD, 20.9 %). The most involved mechanisms of action drug categories are farnesoid X receptor (FXR) agonists and peroxisome proliferator-activated receptor (PPAR) agonists, with the most tested drugs being the FXR agonist EDP-305 and the Glucagon-like peptide-1 (GLP-1) agonist semaglutide.Old drugs are further repurposed for testing in NASH treatment, novel drugs are developed to try to cure NASH. We expect that the drug clinical trials will accelerate the frontier of therapeutic development in NASH, bring an innovative and efficacious medication therapeutic approach to prevent the development and progression of NASH, or even reverse NASH.Copyright © 2023 Research Trust of DiabetesIndia (DiabetesIndia) and National Diabetes Obesity and Cholesterol Foundation (N-DOC). Published by Elsevier Ltd. All rights reserved.

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Q1 ENDOCRINOLOGY & METABOLISM

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第一作者机构: [1]Department of Pharmacy, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing Engineering Research Center [2]Department of Physiology, The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, MD9-04-11, 2 Medical Drive, Singapore, 117593, Singapore [3]Drug and medical device clinical trial institution/Department of pharmacy, China Emergency General Hospital, Beijing, 100028, China
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通讯机构: [1]Department of Pharmacy, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing Engineering Research Center [2]Department of Physiology, The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, MD9-04-11, 2 Medical Drive, Singapore, 117593, Singapore [6]CAMP, Singapore-MIT Alliance for Research and Technology, 1 CREATE Way, Level 4 Enterprise Wing, Singapore, 138602, Singapore [7]Mechanobiology Institute, National University of Singapore, T-Lab, #05-01, 5A Engineering Drive 1, Singapore, 117411, Singapore [*1]Department of Pharmacy, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing Engineering Research Center for Nerve System Drugs, Beijing Municipal Geriatric Medical Research Center, Beijing 100053, China [*2]Department of Physiology, The Institute for Digital Medicine (WisDM), Yong Loo Lin School of Medicine, MD9-04-11, 2 Medical Drive, Singapore 117593, Singapore
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