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Doctor","15990006685","Guoping.sheng@shulan.com",{"facility":712,"status":41,"city":698,"state":699,"zip":713,"country":45,"countryCode":46,"cosmosGeoPoint":714,"geoPoint":716,"contacts":717},"Rui'an People's Hospital","325200",{"type":48,"coordinates":715},[703,704],{"lat":704,"lon":703},[718],{"name":719,"role":31,"phone":720,"phoneExt":24,"email":721},"Liang Hong, Bachelor","13958805550","rahoshongliang@163.com",{"facility":723,"status":41,"city":724,"state":699,"zip":725,"country":45,"countryCode":46,"cosmosGeoPoint":726,"geoPoint":730,"contacts":731},"Ningbo Medical Treatment Center Lihuili Hospital","Ningbo","315040",{"type":48,"coordinates":727},[728,729],121.54945,29.87819,{"lat":729,"lon":728},[732],{"name":733,"role":31,"phone":734,"phoneExt":24,"email":735},"Lanman Xu, Doctor","13587646315","13587646315@163.com",{"facility":737,"status":41,"city":738,"state":699,"zip":739,"country":45,"countryCode":46,"cosmosGeoPoint":740,"geoPoint":744,"contacts":745},"Yiwu Central Hospital","Yiwu","322099",{"type":48,"coordinates":741},[742,743],120.07676,29.31506,{"lat":743,"lon":742},[746],{"name":747,"role":31,"phone":748,"phoneExt":24,"email":749},"Dong Yan, Doctor","15906607100","yandonh@163.com",{"facility":751,"status":41,"city":752,"state":699,"zip":753,"country":45,"countryCode":46,"cosmosGeoPoint":754,"geoPoint":758,"contacts":759},"Zhoushan Hospital","Zhoushan","316100",{"type":48,"coordinates":755},[756,757],122.20488,29.98869,{"lat":757,"lon":756},[760],{"name":761,"role":31,"phone":762,"phoneExt":24,"email":763},"Qiujing Wang, Master","13857224785","qiujing726@163.com",{"facility":765,"status":41,"city":766,"state":766,"zip":767,"country":45,"countryCode":46,"cosmosGeoPoint":768,"geoPoint":772,"contacts":773},"Zhoukou Central Hospital","Zhoukou","466099",{"type":48,"coordinates":769},[770,771],114.63333,33.63333,{"lat":771,"lon":770},[774],{"name":775,"role":31,"phone":776,"phoneExt":24,"email":777},"Junying Liu, Doctor","18539768877","liujunying781025@163.com",{"type":779,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100559852","phase-2-efficacy-and-safety-of-recombinant-human-fgf21-fc-fusion-protein-for-injection-tqa2225ap025-in-adult-subjects-with-non-alcoholic-steatohepatitis-nash-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":791,"type":792},120,"ESTIMATED","INTERVENTIONAL",[795],"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)",[798],"Non-alcoholic Steatohepatitis","2024-08-22",{"date":801,"type":802},"2024-08-26","ACTUAL",{"date":804,"type":802},"2023-09-14",{"date":806,"type":792},"2027-12",{"name":808,"class":6},"Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.",53]