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Doctor","15990006685","Guoping.sheng@shulan.com",{"facility":711,"status":41,"city":697,"state":698,"zip":712,"country":45,"cosmosGeoPoint":713,"geoPoint":715,"contacts":716},"Rui'an People's Hospital","325200",{"type":47,"coordinates":714},[702,703],{"lat":703,"lon":702},[717],{"name":718,"role":31,"phone":719,"phoneExt":24,"email":720},"Liang Hong, Bachelor","13958805550","rahoshongliang@163.com",{"facility":722,"status":41,"city":723,"state":698,"zip":724,"country":45,"cosmosGeoPoint":725,"geoPoint":729,"contacts":730},"Ningbo Medical Treatment Center Lihuili Hospital","Ningbo","315040",{"type":47,"coordinates":726},[727,728],121.54945,29.87819,{"lat":728,"lon":727},[731],{"name":732,"role":31,"phone":733,"phoneExt":24,"email":734},"Lanman Xu, Doctor","13587646315","13587646315@163.com",{"facility":736,"status":41,"city":737,"state":698,"zip":738,"country":45,"cosmosGeoPoint":739,"geoPoint":743,"contacts":744},"Yiwu Central Hospital","Yiwu","322099",{"type":47,"coordinates":740},[741,742],120.07676,29.31506,{"lat":742,"lon":741},[745],{"name":746,"role":31,"phone":747,"phoneExt":24,"email":748},"Dong Yan, Doctor","15906607100","yandonh@163.com",{"facility":750,"status":41,"city":751,"state":698,"zip":752,"country":45,"cosmosGeoPoint":753,"geoPoint":757,"contacts":758},"Zhoushan Hospital","Zhoushan","316100",{"type":47,"coordinates":754},[755,756],122.20488,29.98869,{"lat":756,"lon":755},[759],{"name":760,"role":31,"phone":761,"phoneExt":24,"email":762},"Qiujing Wang, Master","13857224785","qiujing726@163.com",{"facility":764,"status":41,"city":765,"state":765,"zip":766,"country":45,"cosmosGeoPoint":767,"geoPoint":771,"contacts":772},"Zhoukou Central Hospital","Zhoukou","466099",{"type":47,"coordinates":768},[769,770],114.63333,33.63333,{"lat":770,"lon":769},[773],{"name":774,"role":31,"phone":775,"phoneExt":24,"email":776},"Junying Liu, Doctor","18539768877","liujunying781025@163.com",{"type":778,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100559852",false,"NCT06569524","Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225\u002FAP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)","A Double-blind, Placebo Randomized，Phase II Study to Evaluate the Efficacy and Safety of TQA2225\u002FAP025 in Adults With Nonalcoholic Steatohepatitis (NASH)","Inclusion Criteria:\n\n* Must be willing to participate in the study and provide written informed consent.\n* Male or female aged 18 ≤ age \\\u003C 75 at the time of signing the informed consent.\n* Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a NAS of ≥4 with at least a score of 1 in each of the lobular inflammation and ballooning degeneration.\n* Confirmation of ≥10% liver fat content on Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF).\n* Weight changes≤5% in the 6 weeks prior to randomization.\n* No qualitative change in dose for the drugs listed below:\n\n  1. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): for at least 3 months\n  2. Vitamin E (if at a dose ≥400 IU\u002Fday): for at least 6 months\n  3. Statins: for at least 3 months\n* Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 6 month after treatment discontinuation.\n\nExclusion Criteria:\n\n* Documented causes of chronic liver disease other than NASH\n* Type 1 diabetes or uncontrolled Type 2 diabetes defined as:Hemoglobin A1c ≥9% at screening，Fasting blood glucose≥13.9mmol\u002Fl\n* Uncontrolled hypertension at Screening (values ≥160\u002F100 mm Hg)\n* History or presence of cirrhosis\n* Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period;\n* Unable or unwilling to undergo liver biopsy according to research requirements.\n* History of weight loss surgery within 5 years (inclusive) prior to screening\n* A major surgery was performed 3 months prior to signing the Informed Consent Form (ICF), or planned during the study period.\n* Have experienced any bone trauma, fracture, or bone surgery within ≤ 2 months prior to screening.\n* When screening, according to the results of dual energy X-ray absorptiometry (DXA) examination, it meets the criteria for osteoporosis: T≤ -2.5\n* Recent history of drug abuse (defined as ≤ 2 years).\n* Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening.\n* Abnormal laboratory test values：ALT or AST \\>5 × ULN；Serum ALP≥2× ULN；eGFR\\\u003C60mL\u002Fmin；INR\\>1.3× ULN；platelets \\\u003C LLN.\n* Pregnant or breastfeeding women.\n* Liver transplantation history or planned liver transplantation\n* Contraindications for MRI examination\n* Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.","ALL","18 Years","75 Years",{"count":789,"type":790},120,"ESTIMATED","INTERVENTIONAL",[793],"PHASE2","A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225\u002FAP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)",[796],"Non-alcoholic Steatohepatitis","2024-08-22",{"date":799,"type":800},"2024-08-26","ACTUAL",{"date":802,"type":800},"2023-09-14",{"date":804,"type":790},"2027-12",{"name":806,"class":6},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",53]