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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
To evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH)
To evaluate the efficacy and safety of TQA2225/AP025 (50mg) in patients with Non-Alcoholic Steatohepatitis (NASH)
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
Time frame: After week 48 of TQA2225/AP025 treatment
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and percentage of adverse events and serious adverse events
Time frame: Baseline to week 48
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Lu'an Traditional Chinese Medicine Hospital
Lu'an, Anhui, China
NOT_YET_RECRUITINGLu'an People's Hospital
Lu'an, Anhui, China
NOT_YET_RECRUITINGBeijing You 'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGMengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China
NOT_YET_RECRUITINGXiamen Traditional Chinese Medicine Hospital
Xiamen, Fujian, China
NOT_YET_RECRUITINGWuwei Cancer Hospital of Gansu Province
Wuwei, Gansu, China
NOT_YET_RECRUITINGPeking University Shenzhen Hospital
Shenzhen, Guangdong, China
NOT_YET_RECRUITINGLiuzhou Worker's Hospital
Liuchow, Guangxi, China
NOT_YET_RECRUITINGLiuzhou Liutie Central Hospital
Liuchow, Guangxi, China
NOT_YET_RECRUITINGYuLin Red Cross Hospital
Yulin, Guangxi, China
NOT_YET_RECRUITING...and 43 more locations