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Chiglitazar in MASLD with hypertriglyceridemia and insulin resistance: A phase II, randomized, double-blind, placebo-controlled study

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作者：
Sun Yameng[1] * ; Wu Cuisong[2] ; Xin Guijie[3] ; Zhong Bihui[4] ; Wu Xiaofeng[5] ; Liu Yali[6] ; Shi Junping[7] ; Zhang Qin[8] ; Zhao Yingren[9] ; Gao Yufeng[10] ; Xin Yongning[11] ; Zhu Yueyong[12] ; Wu Lixian[13] ; Mao Xiaorong[14] ; Du Jian[15] ; Shang Jia[16] ; Sun Weiwei[17] ; Xu Jie[18] ; Yu Zujiang[19] ; Nan Yuemin[20] ; Sheng Huiping[21] ; Li Yue[22] ; Rao Huiying[23] ; Yu Chaohui[24] ; Cao Haixiang[25] ; Chen Bo[25] ; Li Zhibin[25] ; Wu Xiaoning[1] ; Tong Xiaofei[1] ; You Hong[1] ;
机构： [1]Liver Research Center, Beijing Friendship Hospital, Capital Medical University, State Key Lab of Digestive Health, National Clinical Research Center of Digestive Diseases, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, Beijing, China. [2]Department of Infection, the Third People's Hospital of Zhenjiang, Zhenjiang, Jiangsu, China. [3]Department of Hepatology, The First Hospital of Jilin University, Changchun, Jilin, China. [4]Department of Gastroenterology, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China. [5]Department of Hepatology, Shenyang Sixth People's Hospital, Shenyang, Liaoning, China. [6]International Medical Department, Beijing Youan Hospital, Capital Medical University, Beijing, China. [7]Department of Infectious Diseases and Hepatology, the Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang, China. [8]Department of Infectious Diseases, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [9]Department of Infectious Diseases, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China. [10]Department of Infectious Disease, the First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China. [11]Department of Infectious Diseases, Qingdao Municipal Hospital, Qingdao University, Qingdao, Shandong, China. [12]Department of Hepatology, The First Affiliated Hospital of Fujian Medical University, Fuzhou, Fujian, China. [13]Department of Infectious Diseases, The First People's Hospital of Foshan, Foshan, Guangdong, China. [14]Department of Infectious Disease, The First Hospital of Lanzhou University, Lanzhou, Gansu, China. [15]Department of Endocrinology, The Fourth Affiliated Hospital of China Medical University, Shenyang, Liaoning, China. [16]Department of Infectious Diseases, Henan Provincial People's Hospital, Zhengzhou, Henan, China. [17]Department of Hepatology, The Second Hospital of Nanjing, Nanjing, Jiangsu, China. [18]Department of Infectious Diseases, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. [19]Department of Infectious Disease, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China. [20]Department of Integrated Traditional Chinese and Western Medicine for Liver Diseases, the Third Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. [21]Department of Infectious Diseases, General Hospital of NingXia Medical University, Yinchuan, Ningxia, China. [22]Department of Endocrinology, Shunde Hospital, Southern Medical University, Foshan, Guangdong, China. [23]Peking University Hepatology Institute, Peking University People's Hospital, Beijing, China. [24]Department of Gastroenterology, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China. [25]Chengdu Chipscreen Pharmaceutical Co., Ltd. Chengdu, Sichuan, China.
出处：
DOI： 10.1097/HEP.0000000000001475
ISSN：

关键词： chiglitazar metabolic dysfunction-associated steatohepatitis liver fat content phase II

摘要：
Metabolic dysfunction-associated steatotic liver disease (MASLD) can progress to severe forms such as metabolic dysfunction-associated steatohepatitis (MASH). Effective treatments for MASH are urgently needed. This study aimed to evaluate the efficacy and safety of chiglitazar, a PPAR pan-agonist, in MASLD with hypertriglyceridemia and insulin resistance.In this phase II multicenter, randomized, double-blind and placebo-controlled study, 104 patients with MASLD with hypertriglyceridemia and insulin resistance were randomized 2:2:1 to receive 48 mg, 64 mg of chiglitazar, or placebo once daily for 18 weeks. The primary endpoint was the percentage change in liver fat content measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF) at week 18. Chiglitazar significantly reduced liver fat content, with percentage change from baseline at week 18 of -28.1% (95% CI -37.5 to -18.7) in the 48 mg group and -39.5% (95% CI -49.0 to -30.0) in the 64 mg group, compared to -3.2% (95% CI -16.8 to 10.4) in placebo group. The differences compared to placebo were -24.9% (p<0.05) for the 48 mg group and -36.3% (p<0.001) for the 64 mg group. Chiglitazar also significantly improved liver injury-related biomarkers such as ALT, AST and γ-GT. Liver fibrosis indicators, lipid parameters, insulin resistance and metabolic syndrome, showed improved trend. Both doses of chiglitazar were well tolerated, with most adverse events being mild to moderate.Chiglitazar significantly reduced liver fat content in MASLD with hypertriglyceridemia and insulin resistance, with a dose-dependent effect and favorable safety profile.Copyright © 2025 The Author(s). Published by Wolters Kluwer Health, Inc.

基金：
The study was supported by Chengdu Chipscreen Pharmaceutical Co., Ltd.
语种：
外文
PubmedID：
中科院(CAS)分区：
出版当年[2025]版：
大类 | 1 区 医学
小类 | 1 区 胃肠肝病学
最新[2025]版：
大类 | 1 区 医学
小类 | 1 区 胃肠肝病学
第一作者：
第一作者机构： [1]Liver Research Center, Beijing Friendship Hospital, Capital Medical University, State Key Lab of Digestive Health, National Clinical Research Center of Digestive Diseases, Beijing Key Laboratory of Translational Medicine on Liver Cirrhosis, Beijing, China.
通讯作者：
推荐引用方式(GB/T 7714)：
Sun Yameng,Wu Cuisong,Xin Guijie,et al.Chiglitazar in MASLD with hypertriglyceridemia and insulin resistance: A phase II, randomized, double-blind, placebo-controlled study[J].Hepatology (Baltimore, Md.).2025,doi:10.1097/HEP.0000000000001475.
APA：
Sun Yameng,Wu Cuisong,Xin Guijie,Zhong Bihui,Wu Xiaofeng...&You Hong.(2025).Chiglitazar in MASLD with hypertriglyceridemia and insulin resistance: A phase II, randomized, double-blind, placebo-controlled study.Hepatology (Baltimore, Md.),,
MLA：
Sun Yameng,et al."Chiglitazar in MASLD with hypertriglyceridemia and insulin resistance: A phase II, randomized, double-blind, placebo-controlled study".Hepatology (Baltimore, Md.) .(2025)

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