Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
NCT Number: NCT06569524
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Non-alcoholic Steatohepatitis
Interventions: DRUG: TQA2225/AP025 or TQA2225/AP025 Placebo 25mg|DRUG: TQA2225/AP025 or TQA2225/AP025 Placebo 50mg
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 120
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-14
Completion Date: 2027-12
Locations: Lu'an Traditional Chinese Medicine Hospital, Lu'an, Anhui, 237000, China|Lu'an People's Hospital, Lu'an, Anhui, 237121, China|Beijing You 'an Hospital, Capital Medical University, Beijing, Beijing, 100069, China|Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, Fujian, 350025, China|Xiamen Traditional Chinese Medicine Hospital, Xiamen, Fujian, 361000, China|Wuwei Cancer Hospital of Gansu Province, Wuwei, Gansu, 100069, China|Peking University Shenzhen Hospital, Shenzhen, Guangdong, 518036, China|Liuzhou Worker's Hospital, Liuzhou, Guangxi, 545005, China|Liuzhou Liutie Central Hospital, Liuzhou, Guangxi, 545007, China|YuLin Red Cross Hospital, Yulin, Guangxi, 537099, China|Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital), Qingyuan, Guangzhou, 511436, China|Baoding First Central Hospital, Baoding, Hebei, 071030, China|Cangzhou Central Hospital, Cangzhou, Hebei, 061012, China|Fifth Hospital of Shijiazhuang, Shijiazhuang, Hebei, 050024, China|Shijiazhuang Hospital of Traditional Chinese Medicine, Shijiazhuang, Hebei, 052360, China|Luoyang Central Hospital, Luoyang, Henan, 471000, China|Puyang Oilfield General Hospital, Puyang, Henan, 457001, China|Henan Provincial People's Hospital, Zhengzhou, Henan, 450000, China|Zhengzhou Sixth People's Hospital, Zhengzhou, Henan, 450015, China|Zhengzhou Third People's Hospital, Zhengzhou, Henan, 450099, China|Huazhong University of Science Tongji Hospital, Tongji Medical College, Wuhan, Hubei, 448000, China|The Second Xiangya Hospital of Central South University, Changsha, Hunan, 410000, China|Yueyang Central Hospital, Yueyang, Hunan, 414020, China|Chifeng Hospital, Chifeng, Inner Mongolia, 024099, China|Jiangyin People's Hospital, Jiangyin, Jiangsu, 214499, China|Jiangsu Province Hospital, Nanjing, Jiangsu, 210003, China|Wuxi Fifth People's Hospital, Wuxi, Jiangsu, 214001, China|Affiliated Hospital of Xuzhou Medical University, Xuzhou, Jiangsu, 221000, China|Affiliated Hospital of Jiangsu University, Zhenjiang, Jiangsu, 212001, China|Ganzhou Fifth People's Hospital, Ganzhou, Jiangxi, 341099, China|The Second Hospital of Jilin University, Changchun, Jilin, 130041, China|The Sixth People's Hospital of Shenyang, Shenyang, Liaoning, 110000, China|Shengjing Hospital Affiliated to China Medical University, Shenyang, Liaoning, 110022, China|Liaocheng People's Hospital, Liaocheng, Shandong, 252000, China|Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, 200030, China|Shanghai Tongren Hospital, Shanghai, Shanghai, 200050, China|Shanghai Pudong New Area Gongli Hospital, Shanghai, Shanghai, 200135, China|Shanghai Pudong Hospital, Shanghai, Shanghai, 201399, China|Shanxi Bethune Hospital, Taiyuan, Shanxi, 050081, China|The First Affiliated Hospital of Xi 'an Jiaotong University, Xi'an, Shanxi, 710000, China|Leshan People's Hospital, Leshan, Sichuan, 614099, China|Southwest Medical University Affiliated Hospital, Luzhou, Sichuan, 646099, China|Meishan People's Hospital, Meishan, Sichuan, 620000, China|Mianyang Central Hospital, Mianyang, Sichuan, 621099, China|The First People's Hospital of Zigong City, Zigong, Sichuan, 643000, China|The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, Tianjin, 300193, China|Puer People's Hospital, Puer, Yunnan, 665099, China|Shulan (Hangzhou) Hospital, Hangzhou, Zhejiang, 310022, China|Rui'an People's Hospital, Hangzhou, Zhejiang, 325200, China|Ningbo Medical Treatment Center Lihuili Hospital, Ningbo, Zhejiang, 315040, China|Yiwu Central Hospital, Yiwu, Zhejiang, 322099, China|Zhoushan Hospital, Zhoushan, Zhejiang, 316100, China|Zhoukou Central Hospital, Zhoukou, Zhoukou, 466099, China

Summary:
A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225/AP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)

Primary Outcome Measures: To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline, 1. Proportion with resolution of NASH (ballooning 0, inflammation 0,1) associated with at least 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis stage OR
2. Proportion with at least a 1-point improvement in fibrosis stage with no worsening of NAS, After week 48 of TQA2225/AP025 treatment
Secondary Outcome Measures: Adverse Events (AEs) and Serious Adverse Events (SAEs), Number and percentage of adverse events and serious adverse events, Baseline to week 48