天津NAIII期临床试验-一项在2型糖尿病成人参与者中评价Elecoglipron与口服司美格鲁肽相比的有效性和安全性的III期研究

登记号	CTR20263210	试验状态	进行中
申请人联系人	阿斯利康临床试验热线	首次公示信息日期	2026-08-21
申请人名称	AstraZeneca AB/ 阿斯利康全球研发（中国）有限公司/ AstraZeneca AB；AstraZeneca AB；Hovione Farmaciencia S.A.

登记号	CTR20263210
相关登记号	暂无
药物名称	NA
药物类型	化学药物
临床申请受理号	企业选择不公示
适应症	2型糖尿病
试验专业题目	一项在2型糖尿病成人参与者中评价Elecoglipron与口服司美格鲁肽相比的有效性、安全性和耐受性的随机、开放标签、平行分组III期研究（Eluminate-2）
试验通俗题目	一项在2型糖尿病成人参与者中评价Elecoglipron与口服司美格鲁肽相比的有效性和安全性的III期研究
试验方案编号	D7261C00005	方案最新版本号	1.0
版本日期:	2026-03-16	方案是否为联合用药	否

申请人名称	[["AstraZeneca AB"],["阿斯利康全球研发（中国）有限公司"],["AstraZeneca AB；AstraZeneca AB；Hovione Farmaciencia S.A."]]
联系人姓名	阿斯利康临床试验热线	联系人座机	021-61308402	联系人手机号
联系人Email	Clinical-Trial-Disclosure-Mailbox@astrazeneca.com	联系人邮政地址	上海市-上海市-静安区西藏北路88号阿斯利康	联系人邮编	200085

本研究旨在评估Elecoglipron与口服司美格鲁肽相比，在心血管疾病风险升高、且生活方式管理或其他降糖药物基础上治疗但血糖仍管理不佳的成人T2DM参与者中的有效性、安全性和耐受性。

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	开放	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["在筛选访视前至少90天，已被诊断为T2DM的参与者"],["仅通过生活方式管理或者接受其他稳定降糖药物但血糖仍管理不佳的T2DM参与者"],["HbA1c ≥ 7%且≤ 10.5%（53-91.3 mmol/mol）"],["心血管事件发生风险升高，定义为至少符合下列一种情况：(a) 冠心病； (b) 外周动脉疾病；(c) 脑血管疾病；(d) 心力衰竭（NYHA II或III级）；(e) 至少具备2项心血管风险因素"],["筛选访视时BMI ≥ 23 kg/m2"],["在筛选访视前90天内参与者的体重保持稳定（由参与者自述或有记录）"]]
排除标准	[["1型糖尿病、继发性糖尿病（包括先天性类型），或存在酮症酸中毒或高渗性昏迷病史"],["目前正在接受，或预期将接受糖尿病视网膜病变和/或黄斑水肿的治疗干预。"],["在筛选访视前180天内发生超过1次重度低血糖发作，或存在无知觉或症状识别不佳的低血糖病史"],["患有具有临床意义的上消化道疾病，或长期使用任何可能影响胃动力或胃排空的药物"],["急性或慢性胰腺炎病史"],["重度充血性心力衰竭（NYHA IV级）"],["甲状腺髓样癌或2型多发性内分泌瘤病史或家族史"]]

试验药	[["中文通用名:NA 英文通用名:Elecoglipron 商品名称:NA","剂型:薄膜包衣片 规格:Amg、Bmg、Cmg、Dmg 用法用量:每日一次，口服 用药时程:52周"],["中文通用名:NA 英文通用名:Elecoglipron 商品名称:NA","剂型:薄膜包衣片 规格:Amg、Bmg、Cmg、Dmg 用法用量:每日一次，口服 用药时程:52周"]] 序号 名称 用法
对照药	[["中文通用名:司美格鲁肽 英文通用名:Semaglutide 商品名称:Rybelsus","剂型:片剂 规格:1.5mg 用法用量:1.5mg，每日一次口服 用药时程:52周"],["中文通用名:司美格鲁肽 英文通用名:Semaglutide 商品名称:Rybelsus","剂型:片剂 规格:4mg 用法用量:4mg，每日一次口服 用药时程:52周"],["中文通用名:司美格鲁肽 英文通用名:Semaglutide 商品名称:Rybelsus","剂型:片剂 规格:9mg 用法用量:9mg，每日一次口服 用药时程:52周"]] 序号 名称 用法

主要终点指标及评价时间

[["HbA1c（%）较基线的变化","第52周时","有效性指标"]] 序号 指标 评价时间 终点指标选择

次要终点指标及评价时间

[["- 第52周时体重较基线的变化百分比n- 第52周时体重（kg）较基线的变化","第52周时","有效性指标"],["第52周时达到体重较基线降低≥ 5%，且HbA1c < 7%（53 mmol/mol）","第52周时","有效性指标"],["- 第52周时达到HbA1c ≤ 6.5%（48 mmol/mol）n- 第52周时达到HbA1c < 7%（53 mmol/mol）","第52周时","有效性指标"],["第52周时体重较基线降低≥ 5%","第52周时","有效性指标"],["第52周时血压降低较基线的变化：n° 收缩压n° 舒张压","第52周时","有效性指标"],["评估Elecoglipron与口服司美格鲁肽相比的安全性和耐受性:n- AE、SAE、导致死亡结局的SAE、DAE、研究者评估为可能有关的AE以及导致剂量降低的AEn- 实验室指标n- 生命体征和ECGn- AESI","基线至第52周期间","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	陈莉明	学位	医学博士	职称	主任医师
	电话	022-59560903	Email	xfx22081@vip.163.com	邮政地址	天津市-天津市-北辰区环瑞北路6号
	邮编	300134	单位名称	天津医科大学朱宪彝纪念医院

[["天津医科大学朱宪彝纪念医院","陈莉明","中国","天津市","天津市"],["淮安市第二人民医院","胡文","中国","江苏省","淮安市"],["河北中石油中心医院","韩洁","中国","河北省","廊坊市"],["连云港市第一人民医院","徐宁","中国","江苏省","连云港市"],["中南大学湘雅三医院","金萍","中国","湖南省","长沙市"],["长沙市第三医院","黄德斌","中国","湖南省","长沙市"],["南京市第一医院","李倩","中国","江苏省","南京市"],["安徽医科大学第二附属医院","潘天荣","中国","安徽省","合肥市"],["萍乡市人民医院","张雅薇","中国","江西省","萍乡市"],["南阳市第二人民医院","尚军洁","中国","河南省","南阳市"],["岳阳市中心医院","张响华","中国","湖南省","岳阳市"],["北京市平谷区医院","李玉凤","中国","北京市","北京市"],["合肥市第二人民医院","叶军","中国","安徽省","合肥市"],["河北医科大学第二医院","张力辉","中国","河北省","石家庄市"],["洛阳市中心医院","张艳芳","中国","河南省","洛阳市"],["Centro de Investigacion y Prevencion Cardiovascular SA (CIPREC)","Juliana Mociulsky","阿根廷","Ciudad de Buenos Aires","Ciudad de Buenos Aires"],["Instituto de Investigaciones Clinicas San Nicolas","Maria Fernandez","阿根廷","San Nicolas","San Nicolas"],["Centro Medico Viamonte","Diego Aizenberg","阿根廷","CABA","CABA"],["Expertia S.A- Mautalen Salud e Investigacion","Jose Osvaldo Fretes","阿根廷","Caba","Caba"],["Centro Medico Dra Maffei - Investigacion Clinica Aplicada","Antonella Mainardi","阿根廷","Buenos Aires","Buenos Aires"],["Instituto de Investigaciones Clinicas de Rosario","Carolina Chacon","阿根廷","Rosario","Rosario"],["Centro Medico Privado San Vicente Diabetes","Cecilia Luquez","阿根廷","San Vicente","San Vicente"],["Baker Heart and Diabetes Institute","Anne Reutens","澳大利亚","Melbourne","Melbourne"],["Royal North Shore Hospital","Sarah Glastras","澳大利亚","St Leonards","St Leonards"],["The Royal Melbourne Hospital","Spiros Fourlanos","澳大利亚","Parkville","Parkville"],["Heidelberg Repatriation Hospital","Elif Ekinci","澳大利亚","Heidelberg Heights","Heidelberg Heights"],["Emeritus Research Sydney","Priya Loomba","澳大利亚","Botany","Botany"],["St Vincent's Hospital","Richard MacIsaac","澳大利亚","Fitzroy","Fitzroy"],["Nepean Hospital","Kathryn Williams","澳大利亚","Kingswood","Kingswood"],["Regional Research Institute","Anudeep Gupta","澳大利亚","East Toowoomba","East Toowoomba"],["Instituto Dante Pazzanese","Kleber Franchini","巴西","Sao Paulo","Sao Paulo"],["Instituto Atena De Pesquisa Clinica Ltda","Maria Sanali Moura de Oliveira Paiva","巴西","Natal","Natal"],["Hospital de Clinicas de Porto Alegre","Alexandre Araujo Pereira","巴西","Porto Alegre","Porto Alegre"],["Associacao de Amparo a Saude, Ensino e Pesquisa","Joao Borges","巴西","Brasilia","Brasilia"],["ISPEM - Instituto Sao Jose dos Campos em Pesquisas Medicas (Map Clinica Medica De Endocrinologia Ltda)","Marcio Pereira","巴西","Sao Jose dos Campos","Sao Jose dos Campos"],["HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas","Danilo Glauco Villagelin Neto","巴西","Campinas","Campinas"],["Leite PS Consultoria Medica LTDA","Silmara Aparecida Leite","巴西","Curitiba","Curitiba"],["UMHAT Kaspela EOOD","Boyan Nonchev","保加利亚","Plovdiv","Plovdiv"],["Medical centers Fi Health AD","Roza Borislavova","保加利亚","Sofia","Sofia"],["Medical Arts Medical and Dental Center","Yavor Assyov","保加利亚","Sofia","Sofia"],["MC Berbatov EOOD","Dimitar Berbatov","保加利亚","Yambol","Yambol"],["Acibadem City Clinic Hospital Tokuda","Lachezar Lozanov","保加利亚","Sofia","Sofia"],["LMC Healthcare","Adel Hanna","加拿大","Scarborough","Scarborough"],["Diabetes Heart Research Centre","Luis Noronha","加拿大","Toronto","Toronto"],["Dr Anil K Gupta Medicine Professional Corporation","Anil Gupta","加拿大","Toronto","Toronto"],["Bluewater Clinical Research Group","John O'Mahony","加拿大","Sarnia","Sarnia"],["Stouffville Medical Research Institute Inc.","Douglas Wu","加拿大","Stouffville","Stouffville"],["Centre Medical Acadie","Ronald Akhras","加拿大","Montreal","Montreal"],["Dr. T.G. Elliott Inc. (DBA BC Diabetes)","Thomas Elliott","加拿大","Vancouver","Vancouver"],["Dawson Clinical Research","Garry Wallace","加拿大","Guelph","Guelph"],["Clinique de Pneumologie et de Sommeil de Lanaudiere","Bonavuth Pek","加拿大","St Charles Borromee","St Charles Borromee"],["ClinSurge Research","Ronnie Aronson","加拿大","Toronto","Toronto"],["RED-Institut GmbH","Thomas Schaum","德国","Oldenburg","Oldenburg"],["Medizinisches Versorgungszentrum am Bahnhof Spandau","Uta Stephan","德国","Berlin","Berlin"],["Gemeinschaftspraxis fuer Innere Medizin und Diabetologie","Jens Aberle","德国","Hamburg","Hamburg"],["Diabeteszentrum Wilhelmsburg","Peter Witzel","德国","Hamburg","Hamburg"],["Herz- und Diabeteszentrum NRW","Susanne Reger-Tan","德国","Bad Oeynhausen","Bad Oeynhausen"],["Zentrum fuer klinische Forschung Allgaeu Oberschwaben","Joachim Sauter","德国","Wangen","Wangen"],["Zentrum fur klinische Studien Sudbrandenburg GmbH","Andreas Hagenow","德国","Elsterwerda","Elsterwerda"],["Diabetologische Schwerpunktpraxis","Heidrun Taschner","德国","Leipzig","Leipzig"],["Institut fuer Diabetesforschung","Ludger Rose","德国","Muenster","Muenster"],["Zentrum fuer Klinische Studien Alexander Segner","Alexander Segner","德国","Sankt Ingbert","Sankt Ingbert"],["Praxis Dr. H. Wubbolding","Hubert Wubbolding","德国","Damme","Damme"],["DZDM - Diabetes Zentrum Duisburg Mitte","Alain Barakat","德国","Duisburg","Duisburg"],["Hausarztzentrum Butendorf","Stefan Schaub","德国","Gladbeck","Gladbeck"],["Praxis Dipl. med. Ch. Kosch","Christine Kosch","德国","Pirna","Pirna"],["Praxis Dr. Ludemann","Joerg Luedemann","德国","Falkensee","Falkensee"],["Klinikum Chemnitz gGmbH","Thaddaus Till Wissniowski","德国","Chemnitz","Chemnitz"],["Universitatsklinikum Erlangen","Yurdagul Zopf","德国","Erlangen","Erlangen"],["Med-Tima Kft.","Timea Tanczer","匈牙利","Budapest","Budapest"],["Debreceni Egyetem Klinikai Kozpont","Denes Pall","匈牙利","Debrecen","Debrecen"],["Szegedi Tudomanyegyetem, Szent-Gyorgyi Albert Klinikai Kozpont","Robert Takacs","匈牙利","Szeged","Szeged"],["ClinDiab Kft.","Krisztina Wudi","匈牙利","Budapest","Budapest"],["Obudai Egeszsegugyi Centrum Kft","Viktor Vass","匈牙利","Budapest","Budapest"],["Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Centro Cardiologico Monzino","Stefano Genovese","意大利","Milano","Milano"],["Policlinico Umberto I","Raffaella Buzzetti","意大利","Roma","Roma"],["AZIENDA OSPEDALIERA POLICLINICO S. ORSOLA - MALPIGHI","Uberto Pagotto","意大利","Bologna","Bologna"],["IRCCS Ospedale San Raffaele","Emanuela Setola","意大利","Milano","Milano"],["Fondazione IRCCS Policlinico universitario Gemelli","Andrea Giaccari","意大利","Roma","Roma"],["CAST - Center for Advanced Studies and Technology di Chieti","Gloria Formoso","意大利","Chieti","Chieti"],["Universita degli Studi della Campania Luigi Vanvitelli","Katherine Esposito","意大利","NAPOLI","NAPOLI"],["OSPEDALE CIVILE - OSPEDALE S. AGOSTINO - ESTENSE","Vincenzo Rochira","意大利","Modena","Modena"],["AZIENDA OSPEDALIERA","Francesco Giorgino","意大利","BARI","BARI"],["Itabashi diabetes and dermatology clinic","Naoki Itabashi","日本","Koga-shi","Koga-shi"],["Heiwadai Hospital","Shuji Nakamura","日本","Miyazaki-shi","Miyazaki-shi"],["Nagoya City University Hospital","Hiroyuki Koyama","日本","Nagoya-shi","Nagoya-shi"],["Japanese Red Cross Asahikawa Hospital","Atsuko Abiko","日本","Asahikawa-shi","Asahikawa-shi"],["Naka Memorial Clinic","Takeshi Osonoi","日本","Naka","Naka"],["Takai Internal Medicine Clinic","Masahiko Takai","日本","Kamakura-shi","Kamakura-shi"],["Nakamoto Medical Clinic","Shinya Nakamoto","日本","Mito-shi","Mito-shi"],["Nishiyamado Keiwa Hospital","Sumiko Hasumi","日本","Naka City","Naka City"],["Hayashi Clinic","Isao Hayashi","日本","Nishinomiya-shi","Nishinomiya-shi"],["The institute for adult diseases Asahi Life Foundation","Yukiko Onishi","日本","Chuo-ku","Chuo-ku"],["Kanno Naika","Kazuo Kanno","日本","Mitaka-shi","Mitaka-shi"],["Federation of National Public Service Takamatsu Hospital","Satoshi Murao","日本","Takamatsu-shi","Takamatsu-shi"],["Clinic TOSAKI","Takahiro Tosaki","日本","Nagoya-shi","Nagoya-shi"],["Sasaki Internal Medicine","Keiko Sakai","日本","Sapporo","Sapporo"],["Nzoz Medyczne Centrum Diab-Endo-Met","Joanna Maria Mirocka","波兰","Krakow","Krakow"],["Centrum Terapii Wspolczesnej","Malgorzata Jozefowska","波兰","Lodz","Lodz"],["Ekamed Sp. z o.o.","Ewa Szyprowska","波兰","Lublin","Lublin"],["Panstwowy Instytut Medyczny MSWiA","Edward Franek","波兰","Warszawa","Warszawa"],["Prywatny Gabinet Lekarski, Centrum Medyczne Diabetika Dorota Mlodawska-Choluj","Dorota Mlodawska-Choluj","波兰","Radom","Radom"],["NZOZ GynCentrum - Oddzial Warszawa","Alina Kurylowicz","波兰","Warszawa","Warszawa"],["ClinicMed Daniluk, Nowak Sp. k.","Stefan Daniluk","波兰","Bialystok","Bialystok"],["Uniwersyteckie Centrum Stomatologii i Medycyny Specjalistycznej Sp. z o.o.","Aleksandra Uruska","波兰","Poznan","Poznan"],["Chungnam National University Hospital","Bon Jeong Ku","韩国","Daejeon","Daejeon"],["Gachon University Gil Hospital","Kiyoung Lee","韩国","Incheon","Incheon"],["Chilgok Kyungpook National University Medical Center","Jae Han Jeon","韩国","Daegu","Daegu"],["Kyung Hee University Hospital at Gangdong","In Kyung Jeong","韩国","Seoul","Seoul"],["Hanyang University Guri Hospital","Sung Hoon Yu","韩国","Guri-si","Guri-si"],["Samsung Medical Center","Jae Hyeon Kim","韩国","Seoul","Seoul"],["National Taiwan University Hospital","Chih-Yuan Wang","中国台湾","Taipei","Taipei"],["Taichung Veterans general Hospital - Metabolism Department","Jun-Sing Wang","中国台湾","Taichung","Taichung"],["Kuang Tien General Hospital - Xiangshang","Shih-Ting Tseng","中国台湾","Taichung City","Taichung City"],["Chang-Hua Christian Hospital","Shih-Te Tu","中国台湾","Changhua","Changhua"],["Chung Shan Medical University Hospital","Chien-Ning Huang","中国台湾","Taichung","Taichung"],["National Cheng Kung University Hospital","Yi-Ching Yang","中国台湾","Tainan","Tainan"],["Kaohsiung Veterans General Hospital","Chu Chih-Hsun","中国台湾","Kaohsiung","Kaohsiung"],["Far Eastern Memorial Hospital","Ju-Ying Jiang","中国台湾","New Taipei","New Taipei"],["Chang Gung Medical Foundation Linkou Branch","Feng-Hsuan Liu","中国台湾","Taoyuan","Taoyuan"],["Chi Mei Medical Center","Hung Hao Chang","中国台湾","Yung Kang City","Yung Kang City"],["Aberdeen Royal Infirmary","Sam Philip","英国","Aberdeen","Aberdeen"],["Upton Surgery","Patrick Moore","英国","Poole","Poole"],["Atlantic Medical Group","John Ryan","英国","Penzance","Penzance"],["Banbury Cross Health Centre","James Kennard","英国","Banbury","Banbury"],["GP - Concord Medical Centre","James Case","英国","Bristol","Bristol"],["HMC Health Group - Hounslow","Ivor Singh","英国","Hounslow","Hounslow"],["The Staploe Medical Centre","Anthony Gunstone","英国","Soham","Soham"],["Western General Hospital","Stuart Ritchie","英国","Edinburgh","Edinburgh"],["West Walk Surgery","Sam Davies","英国","Yate","Yate"],["The Crouch Oak Family Practice","Maria Nyekiova","英国","Addlestone","Addlestone"],["Mendip Vale Medical Group","Nafeesa Arshad","英国","Bristol","Bristol"],["Clin Research Advantage, Inc./Desert Clinical Research, LLC","David Shockey","美国","Mesa","Mesa"],["RIO Clinical Trials, LLC","Kenneth Steil","美国","Phoenix","Phoenix"],["AMR Tempe/Phoenix","William Reedy","美国","Tempe","Tempe"],["Headlands Research","Jeffrey Wayne","美国","Sacramento","Sacramento"],["National Instute of Clinical Research","Mallu Reddy","美国","Pomona","Pomona"],["Diagnamics Inc","Ramin Farsad","美国","Encinitas","Encinitas"],["National Institute of Clinical Research","Michael Dao","美国","Garden Grove","Garden Grove"],["Loma Linda University School of Public Health Nutrition Research Center","Warren Peters","美国","Loma Linda","Loma Linda"],["Nature Coast Clinical Research","Scott Redrick","美国","Crystal River","Crystal River"],["University of Florida","Jose Rios","美国","Jacksonville","Jacksonville"],["Avacare Clinical Research Network","Aziz Pirani","美国","Lilburn","Lilburn"],["Family First Medical Center","Flint Packer","美国","Idaho Falls","Idaho Falls"],["DM Clinical Research","Mary Brown","美国","Melrose Park","Melrose Park"],["McFarland Clinic, P.C.","Hugo Rivadeneyra Pasten","美国","Ames","Ames"],["AMR Clinical","Terry Klein","美国","Wichita","Wichita"],["Qualmedica Research","Wayne Bush","美国","Bowling Green","Bowling Green"],["Endocrine and Metabolic Consultants","Helena Rodbard","美国","Rockville","Rockville"],["Avacare Clinical Research Network","Ravi Passi","美国","Rockville","Rockville"],["DM Clinical Research","Rebecca Rivard","美国","Southfield","Southfield"],["Jefferson City Medical Center","Christopher Case","美国","Jefferson City","Jefferson City"],["Alliance for Multispecialty Research, LLC","Martha Fanning","美国","Kansas City","Kansas City"],["Palm Research Center, Inc","Sarah Polis","美国","Las Vegas","Las Vegas"],["Nitovo Health Care","Suresh Neelagaru","美国","Albuquerque","Albuquerque"],["Accellacare","Joseph Moran","美国","Statesville","Statesville"],["Lucas Research Inc.","Kathryn Lucas","美国","Morehead City","Morehead City"],["Velocity Clinical Research","William Cromwell","美国","Durham","Durham"],["Trial Management Associates, LLC","William Jones","美国","Wilmington","Wilmington"],["Tekton Research","Robert Lockwood","美国","Yukon","Yukon"],["DM Clinical Research - Texas Center for Drug Development","Lisa Holloway","美国","Sugar Land","Sugar Land"],["Cope Family Medicine","Bryce Peterson","美国","Bountiful","Bountiful"],["CCT Research","Jared Probst","美国","Salt Lake City","Salt Lake City"],["Alliance for Multispecialty Research, LLC","Mary Bailey","美国","Norfolk","Norfolk"],["Virginia Heart","Karan Desai","美国","Leesburg","Leesburg"],["Seattle Clinical Research Center","Nicole Ehrhardt","美国","Seattle","Seattle"],["Frontier Clinical Research","Ward Paine","美国","Morgantown","Morgantown"],["Velocity Clinical Research, Seattle","John Robinson","美国","Seattle","Seattle"],["Deaconess Clinic","Renee Galen","美国","Evansville","Evansville"],["Accellacare","Neeraj Gupta","美国","Long Beach","Long Beach"],["Remington-Davis, Inc.","Roy St John","美国","Columbus","Columbus"],["Flourish Research Leesburg","Sheyla Zelaya","美国","Leesburg","Leesburg"],["Desert Clinical Research","Mavis Matsumoto","美国","Henderson","Henderson"],["Central Research Associates Inc.","David DeAtkine","美国","Birmingham","Birmingham"],["Valley Clinical Trials, Inc.","Masoud Azizad","美国","Covina","Covina"],["Advanced Medical Research Group","Luis Vicioso-Peralta","美国","Hollywood","Hollywood"],["Quality Clinical Research Inc","Brian Hollis","美国","Omaha","Omaha"],["UT Southwestern Medical Center","Amy Shah","美国","Dallas","Dallas"],["Diabetes & Endocrinology Consultants of Pennsylvania, LLC","Arvind Cavale","美国","Feasterville Trevose","Feasterville Trevose"],["Headlands Research","Uzma Khan","美国","Orlando","Orlando"],["HealthStar Physicians P.C.","Paul Cardali","美国","Morristown","Morristown"],["Medical Colleagues of Texas, LLP","John Adams","美国","Katy","Katy"],["Coastal Carolina Research Center","Shannon Conrad","美国","North Charleston","North Charleston"],["Clinical Trials of Texas Inc","Douglas Denham","美国","San Antonio","San Antonio"],["PlanIt Research, PLLC","Prashant Koshy","美国","Houston","Houston"],["M3 Wake Research - Lake City","Guy Strauss","美国","Lake City","Lake City"],["Alsa Resaearch - Bridgeport","Ilja Hulinsky","美国","Bridgeport","Bridgeport"],["International Diabetes Center","Anders Carlson","美国","Minneapolis","Minneapolis"],["Clinical Research Philadelphia, LLC","Joseph Heether","美国","Philadelphia","Philadelphia"],["M3 Wake Research","Khushbu Chandarana","美国","Raleigh","Raleigh"],["Headlands Research","Donald Eagerton","美国","Myrtle Beach","Myrtle Beach"],["Clinical Neuroscience Solutions","Lisa Usdan","美国","Memphis","Memphis"],["Juno Research LLC","Damaris Vega","美国","Houston","Houston"],["Texas Valley Clinical Research LLC","Eduardo Luna","美国","Weslaco","Weslaco"],["Endocrine Associates","Gerardo Bueso","美国","Houston","Houston"],["Consano Clinical Research LLC","Michelle Welch","美国","San Antonio","San Antonio"],["Rainier Clinical Research Center, Inc","Sheryl Marks","美国","Renton","Renton"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["天津医科大学朱宪彝纪念医院医学伦理委员会","同意","2026-05-09"],["天津医科大学朱宪彝纪念医院医学伦理委员会","同意","2026-06-18"],["天津医科大学朱宪彝纪念医院医学伦理委员会","同意","2026-07-24"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 50 ； 国际: 1200 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；