北京Brenipatide注射液III期临床试验-一项Brenipatide在成年抑郁症参与者的临床研究

登记号	CTR20260283	试验状态	进行中
申请人联系人	朱彤	首次公示信息日期	2026-01-26
申请人名称	Eli Lilly and Company/ 礼来苏州制药有限公司/ Incog Biopharma Services, Inc.

登记号	CTR20260283
相关登记号	暂无
药物名称	Brenipatide注射液
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	抑郁症
试验专业题目	一项在成人抑郁症参与者中评价brenipatide作为辅助治疗与安慰剂相比，在延迟疾病复发时间方面的有效性和安全性的3期、多中心、随机、双盲、平行组设计研究（RENEW-MDD-1）
试验通俗题目	一项Brenipatide在成年抑郁症参与者的临床研究
试验方案编号	J2S-MC-GZMH	方案最新版本号	Amendment a
版本日期:	2025-11-14	方案是否为联合用药	否

申请人名称	[["Eli Lilly and Company"],["礼来苏州制药有限公司"],["Incog Biopharma Services, Inc."]]
联系人姓名	朱彤	联系人座机	021-23021631	联系人手机号	15021603639
联系人Email	zhu_tong@lilly.com	联系人邮政地址	上海市-上海市-静安区石门一路288号太古汇一座19层	联系人邮编	200041

Brenipatide作为稳定SoC药物治疗方案的辅助治疗，在治疗MDD方面优效于安慰剂

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	双盲	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 75岁(最大年龄)
性别	男+女
健康受试者	无
入选标准	[["符合抑郁症的诊断标准"],["正在接受稳定的抑郁症标准治疗药物"],["可靠并愿意在研究期间参加必要的研究访视，并愿意且能够遵循研究程序的要求，例如：n* 自我注射盲态研究治疗n * 按指导储存和使用提供的盲态研究治疗n* 记录电子和纸质研究日志（如适用），和n* 完成研究要求的问卷。"]]
排除标准	[["有以下终生病史或当前诊断患有以下疾病：n* 精神分裂症谱系或其他精神病性障碍n* 双相情感障碍n* 边缘型人格障碍，或n* 任何进食障碍。"],["患有1型糖尿病，或有以下病史：n* 酮症酸中毒，或n* 高渗状态或昏迷。"],["筛选前180天内，有中度或重度物质或酒精使用障碍病史。"],["目前有主动自杀倾向，以及因此被认为有重大自杀风险的。"],["筛选前90天或5个半衰期内（以较长者为准）参加过临床研究并接受过活性药物治疗，或不确定是否接受过活性药物治疗。"]]

试验药	[["中文通用名:Brenipatide 英文通用名:Brenipatide 商品名称:NA","剂型:注射剂 规格:0.47ml 用法用量:皮下注射 用药时程:符合任何研究退出标准，或双盲联合治疗期结束。"],["中文通用名:Brenipatide 英文通用名:Brenipatide 商品名称:NA","剂型:注射剂 规格:0.47ml 用法用量:皮下注射 用药时程:符合任何研究退出标准，或双盲联合治疗期结束。"],["中文通用名:Brenipatide 英文通用名:Brenipatide 商品名称:NA","剂型:注射剂 规格:0.47ml 用法用量:皮下注射 用药时程:符合任何研究退出标准，或双盲联合治疗期结束。"]] 序号 名称 用法
对照药	[["中文通用名:安慰剂 英文通用名:Placebo 商品名称:NA","剂型:注射剂 规格:0.47ml 用法用量:皮下注射 用药时程:符合任何研究退出标准，或双盲联合治疗期结束。"]] 序号 名称 用法

主要终点指标及评价时间

[["疾病复发时间，定义为从随机至参与者达到任何复发标准的日期的天数","从双盲辅助治疗的随机分组到首次复发，至少持续 12 个月","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

[["在基线BMI≥25 kg/m2的参与者中，体重较基线的平均变化百分比","基线，至少持续至 6 个月","有效性指标+安全性指标"],["MADRS总评分较基线的变化","基线，至少持续至 6 个月","有效性指标+安全性指标"],["SDS总体功能损害评分较基线的变化","基线，至少持续至 6 个月","有效性指标+安全性指标"],["PGI-S较基线的变化","基线，至少持续至 6 个月","有效性指标+安全性指标"],["GAD-7总评分较基线的变化","基线，至少持续至 6 个月","有效性指标+安全性指标"],["在基线BMI≥25 kg/m2且使用非典型抗精神病药物的参与者，体重相对于基线的平均百分比变化","基线，至少持续至 6 个月","有效性指标+安全性指标"],["药代动力学 (PK)：Brenipatide 的平均稳态血浆浓度 (Cavg)","给药前，至少持续至 6 个月","有效性指标+安全性指标"],["在治疗过程中产生抗药抗体 (ADA) 的人数","基线，至少持续至 6 个月","有效性指标+安全性指标"],["PROMIS-APSA SF8a总评分较基线的变化","基线，至少持续至 6 个月","有效性指标+安全性指标"],["从基线起患者自评的症状和疾病严重程度的变化","基线，至少持续至 6 个月","有效性指标+安全性指标"],["从基线起健康相关生活质量的变化","基线，至少持续至 6 个月","有效性指标+安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	王刚	学位	精神病与精神卫生学博士	职称	主任医师
	电话	010-58303236	Email	adgangwang@163.com	邮政地址	北京市-北京市-西城区德胜门外安康胡同5号
	邮编	100088	单位名称	首都医科大学附属北京安定医院

[["首都医科大学附属北京安定医院","王刚","中国","北京市","北京市"],["北京大学第六医院","张鸿燕","中国","北京市","北京市"],["北京回龙观医院","谭云龙","中国","北京市","北京市"],["成都市第四人民医院","王飞燕","中国","四川省","成都市"],["广州医科大学附属脑科医院","宁玉萍","中国","广东省","广州市"],["合肥市第四人民医院","郜见亮","中国","安徽省","合肥市"],["河北医科大学第一医院","安翠霞","中国","河北省","石家庄市"],["湖南省第二人民医院（湖南省脑科医院）","周旭辉","中国","湖南省","长沙市"],["湖州市第三人民医院","刘建君","中国","浙江省","湖州市"],["南昌大学第一附属医院","罗涛","中国","江西省","南昌市"],["宁波大学附属康宁医院","徐永明","中国","浙江省","宁波市"],["山东省戴庄医院","刘霞","中国","山东省","济宁市"],["上海市精神卫生中心","洪武","中国","上海市","上海市"],["苏州市广济医院","柳艳松","中国","江苏省","苏州市"],["天津市安定医院","王立娜","中国","天津市","天津市"],["无锡市精神卫生中心","王志强","中国","江苏省","南通市"],["武汉大学人民医院","王惠玲","中国","湖北省","武汉市"],["西安市精神卫生中心","蔺华利","中国","陕西省","西安市"],["延安大学咸阳医院有限公司","胡晓科","中国","陕西省","咸阳市"],["驻马店市第二人民医院(驻马店市精神病医院)","郭华","中国","河南省","驻马店市"],["CEN Centro Especializado en Neurociencias","Hernan Ruggeri","Argentina","Córdoba","Córdoba"],["Centro de Investigaciones Metabólicas (CINME)","Griselda Russo","Argentina","Ciudad Autónoma de Buenos Aires","Ciudad Autónoma de Buenos Aires"],["Centro de Investigación y Asistencia en Psiquiatría (CIAP)","Christian Lupo","Argentina","Rosario","Rosario"],["Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada","Francisco Bruno","Argentina","Ciudad Autonoma de Buenos Aires","Ciudad Autonoma de Buenos Aires"],["Centro Neurobiológico y de Estrés Traumático (CENydET)","Enrique Kuper","Argentina","Buenos Aires","Buenos Aires"],["Clínica de Nefrología, Urología y Enfermedades Cardiovasculares","María Canto","Argentina","Santa Fe","Santa Fe"],["Fundación Lennox - Instituto Modelo de Neurología","Georgina Viczena","Argentina","Córdoba","Córdoba"],["Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM)","Ricardo Corral","Argentina","Buenos Aires","Buenos Aires"],["Fundación para la Lucha contra las Enfermedades Neurológicas de la Infancia (FLENI)","Elsa Costanzo","Argentina","Buenos Aires","Buenos Aires"],["FUNDACION SCHERBOVSKY","Sebastián Rauek","Argentina","Mendoza","Mendoza"],["Global Psy Asociación Civil","Hernan Alessandria","Argentina","La Plata","La Plata"],["Hospital Italiano de Buenos Aires","José Faccioli","Argentina","ABB","ABB"],["Instituto Nacional de Psicopatología (INAPsi)- FunDaMos","Luis Mosca","Argentina","Buenos Aires","Buenos Aires"],["Sanatorio Morra S.A.","Carlos Morra","Argentina","Córdoba","Córdoba"],["Barwon Health","Roth Trisno","Australia","Geelong","Geelong"],["Innovate Clinical Research","Anthony McGirr","Australia","Waitara","Waitara"],["Lyell McEwin Hospital","Dennis Liu","Australia","Elizabeth Vale","Elizabeth Vale"],["Mater Misericordiae Limited","Tatjana Ewais","Australia","Brisbane","Brisbane"],["Mildura Base Hospital","Robert Lundin","Australia","Mildura","Mildura"],["Multidisciplinary Alfred Psychiatry Research Centre","Rebecca Ho","Australia","Melbourne","Melbourne"],["NeuroCentrix","David Barton","Australia","Carlton","Carlton"],["Paratus Clinical Research - Melbourne","Paul Fitzgerald","Australia","Melbourne","Melbourne"],["Toowoomba Hospital","Vikas Garg","Australia","Toowoomba","Toowoomba"],["Westmead Hospital","Vlasios Brakoulias","Australia","Westmead","Westmead"],["A2Z Clinical Centro Avan？ado De Pesquisa Clínica - Valinhos","Caroline da Silva","Brazil","Valinhos","Valinhos"],["BR Trials - Ensaios Clinicos e Consultoria","Acioly Lacerda","Brazil","sao paulo","sao paulo"],["Centro de Pesquisa Clínica de Marília - CPCLIM","Fernanda Guimar？es","Brazil","Marília","Marília"],["Clinilive","Antonio da Silva","Brazil","Maringá","Maringá"],["CPCLIN","Denise Franco","Brazil","Sao Paulo","Sao Paulo"],["CPQuali Pesquisa Clínica","Moacyr Rosa","Brazil","Sao Paulo","Sao Paulo"],["Facili Centro Integrado de Psiquiatria","Cintia de Azevedo Marques Périco","Brazil","S？o Bernardo do Campo","S？o Bernardo do Campo"],["Hospital das Clínicas da UFMG","Frederico Garcia","Brazil","Belo Horizonte","Belo Horizonte"],["Hospital Universitário Onofre Lopes","Walter Soares","Brazil","Natal","Natal"],["Ruschel Medicina e Pesquisa Clínica","Sandra Ruschel","Brazil","Rio De Janeiro","Rio De Janeiro"],["Trial Tech","Hamilton Grabowski","Brazil","Curitiba","Curitiba"],["Alpha Recherche Clinique","Raphael Poulin-Robitaille","Canada","Quebec","Quebec"],["ALPHA Recherche Clinique","Jér？me Nadeau","Canada","Quebec","Quebec"],["Alpha Recherche Clinique - Lévis","Julie Beaudoin","Canada","Lévis","Lévis"],["Bluewater Clinical Research Group Inc.","John O’Mahony","Canada","Sarnia","Sarnia"],["Centre de Recherche Saint-Louis inc.","Catherine Vaillancourt","Canada","Quebec","Quebec"],["Centre for Neurology Studies","Shimi Kang","Canada","Surrey","Surrey"],["Dar Clinical Research - Ottawa","Jabir Jassam","Canada","Ottawa","Ottawa"],["Diex Recherche Inc. Division Joliette","Stephane Noah","Canada","Joliette","Joliette"],["Diex Recherche Sherbrooke","Marylene Dussault","Canada","Sherbrooke","Sherbrooke"],["Genge Partners","Simon Ducharme","Canada","Montreal","Montreal"],["Heritage Medical Research Clinic","Thomas Raedler","Canada","Calgary","Calgary"],["Maple Leaf Research","Graham Smith","Canada","Toronto","Toronto"],["Premier Clinical Trial Network","Richard Tytus","Canada","Hamilton","Hamilton"],["Richmond Clinical Trials","Harris Lari","Canada","Richmond","Richmond"],["Winterberry Research Inc.","Steven Zizzo","Canada","Hamilton","Hamilton"],["FutureMeds GmbH","Erik Lauterbach","Germany","Berlin","Berlin"],["ISPG - Institut für Studien zur Psychischen Gesundheit","Georg Adler","Germany","Mannheim","Mannheim"],["Neurozentrum Bielefeld","Judith Katzmann","Germany","Bielefeld","Bielefeld"],["Pharmakologisches Studienzentrum Chemnitz","Ralf Bodenschatz","Germany","Chemnitz","Chemnitz"],["Somni bene","Heike Benes","Germany","Schwerin","Schwerin"],["Universit？tsklinikum Aachen","Thomas Frodl","Germany","Aachen","Aachen"],["Universit？tsmedizin Johannes Gutenberg Universit？t Mainz","Susanne Englisch","Germany","Mainz","Mainz"],["ZNS Siegen","Eugen Schlegel","Germany","Siegen","Siegen"],["Centro de Atención Integral La Corredoria","Pilar Sáiz","Spain","Oviedo","Oviedo"],["Complejo Asistencial de Zamora","Manuel Franco-Martin","Spain","Zamora","Zamora"],["HOSPITAL CLíNIC DE BARCELONA","Eduard Vieta","Spain","Barcelona","Barcelona"],["Hospital de la Santa Creu i Sant Pau","Narcis Cardoner","Spain","Barcelona","Barcelona"],["Hospital Universitario de Araba (HUA)- Hospital Txagorritxu","I？aki Zorrilla Martínez","Spain","Vitoria-Gasteiz","Vitoria-Gasteiz"],["Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca","ANGEL MONTEJO","Spain","Salamanca","Salamanca"],["Hospital Universitario Infanta Leonor","Javier Quintero","Spain","Madrid","Madrid"],["Hospital Universitari Vall d’Hebron","Josep-Antoni Ramos-Quiroga","Spain","Barcelona","Barcelona"],["INSTITUCION HOSP HESTIA PALAU","Elena Ros Cucurull","Spain","Barcelona","Barcelona"],["Parc de Salut Mar - Hospital del Mar","Victor Pérez-sola","Spain","Barcelona","Barcelona"],["Atlantic Medical","John Ryan","United Kingdom","Penzance","Penzance"],["Clerkenwell Health - London - Welbeck Street","Ahmed Elshashai","United Kingdom","London","London"],["Devon Partnership Trust","Merryn Anderson","United Kingdom","Exeter","Exeter"],["Edinburgh Royal Infirmary","Donald MacIntyre","United Kingdom","Edinburgh","Edinburgh"],["Queen Elizabeth University Hospital","Nagore Penades","United Kingdom","Glasgow","Glasgow"],["Queen’s Medical Centre, Nottingham University Hospitals","Neil Nixon","United Kingdom","Nottingham","Nottingham"],["St Bartholomew’s Medical Centre","Carol Doan","United Kingdom","Oxford","Oxford"],["The Maudsley Hospital","Allan Young","United Kingdom","London","London"],["Warneford Hospital","Riccardo De Giorgi","United Kingdom","Oxford","Oxford"],["Woodstock Bower Surgery","Shahbaz Ali","United Kingdom","Rotherham","Rotherham"],["Aiginiteio University Hospital","NIKOS STEFANIS","Greece","Athens","Athens"],["Argolida General Hospital","Aikaterini Gamvroula","Greece","Argos","Argos"],["ATTIKON GENERAL UNIVERSITY HOSPITAL","Nikolaos Smyrnis","Greece","Chaidari","Chaidari"],["General Hospital of Tripoli Panarkadiko Evangelistria","AIKATERINI GEORGOPOULOU","Greece","Tripoli","Tripoli"],["Multidisciplinary Mental Health Hospital of Attiki","Christos Tsopelas","Greece","Athens","Athens"],["Multidisciplinary Mental Health Hospital of Thessaloniki","Vasilios Bozikas","Greece","Stavroupoli","Stavroupoli"],["Papageorgiou General Hospital of Thessaloniki","LOUKAS ATHANASIADIS","Greece","Thessaloniki","Thessaloniki"],["Abe Clinic - Arakawa","Tetsuo Abe","Japan","Arakawa","Arakawa"],["Arata Clinic","Takatoshi Mori","Japan","Nagasaki","Nagasaki"],["Fujimidai Hospital","Takafumi Yahoko","Japan","Hiratsuka","Hiratsuka"],["Fukuoka University Hospital","Hikaru Hori","Japan","Fukuoka","Fukuoka"],["Himorogi Psychiatric Institute - Tokyo - Ichigayatamachi","Seiji Hongo","Japan","Tokyo","Tokyo"],["Hirota Clinic","Susumu Hirota","Japan","Kurume","Kurume"],["Horikoshi Mental Somatic Clinic","Sho Horikoshi","Japan","Fukushima","Fukushima"],["Jimbocho Mental Clinic","Koji Tada","Japan","Chiyoda","Chiyoda"],["Kishiro Mental Clinic","Masaki Kishiro","Japan","Kawasaki","Kawasaki"],["Kokorono Clinic Hirao","Naoko Kawano","Japan","Fukuoka","Fukuoka"],["Kure Medical Center","Wataru Omori","Japan","Kure","Kure"],["Maynds Tower Mental Clinic","Nobutoshi Kariya","Japan","Shibuya-ku","Shibuya-ku"],["Miki Mental Clinic","Kazuhira Miki","Japan","Yokohama","Yokohama"],["Monzen-nakacho Mental Clinic","Junpei Sekiya","Japan","Koto","Koto"],["Nanko Kokorono Clinic","Seiji Hongo","Japan","Shirakawa","Shirakawa"],["Rainbow and Sea Hospital","Taro Shindo","Japan","Karatsu","Karatsu"],["Sakurazaka Clinic SophyAnce","Haruhito Muto","Japan","Tokyo","Tokyo"],["Sangenjaya Shinkeika Shinryonaika Clinic","Jun Matsushima","Japan","Setagaya","Setagaya,"],["Senzoku Psychosomatic Medicine Clinic","Jun Matsushima","Japan","Meguro-ku","Meguro-ku"],["Shioiri Mental Clinic","Kenichi Goto","Japan","Yokosuka","Yokosuka"],["Suizenji Life Clinic","Tomohiko Matsuo","Japan","Kumamoto","Kumamoto"],["Uematsu Mental Clinic","Ken Uematsu","Japan","Chikugo","Chikugo"],["University of the Ryukyus Hospital","Yoshikazu Takaesu","Japan","Ginowan","Ginowan"],["Yamagata Sakuracho Hospital","Nobuhiro Yokokawa","Japan","Yamagata","Yamagata"],["Yuge Hospital","Masahiro Shono","Japan","Kumamoto-City","Kumamoto-City"],["Yutaka Clinic","Hideo Muraoka","Japan","Sagamihara","Sagamihara"],["Asan Medical Center","Christopher Park","South Korea","Seoul","Seoul"],["Chonnam National University Hospital","JAE-MIN KIM","South Korea","Gwangju-si","Gwangju-si"],["Jeju National University Hospital","JOON HYUK PARK","South Korea","Jeju-si","Jeju-si"],["Konkuk University Medical Center","Hongjun Jeon","South Korea","Seoul","Seoul"],["Korea University Ansan Hospita","Cheolmin Shin","South Korea","Ansan-si","Ansan-si"],["Samsung Medical Center","Hong Jin Jeon","South Korea","Seoul","Seoul"],["Seoul National University Hospital","YONGMIN AHN","South Korea","Seoul","Seoul"],["Severance Hospital, Yonsei University Health System","Chun Il Park","South Korea","Seoul","Seoul"],["The Catholic University of Korea, Yeouido St. Mary’s Hospital","Won-Seok Choi","South Korea","Seoul","Seoul"],["The Catholic Univ. of Korea Seoul St. Mary’s Hospital","Junhee Lee","South Korea","Seoul","Seoul"],["Arké SMO S.A de C.V","Samantha Aranda Pegueros","Mexico","Veracruz","Veracruz"],["B&B Investigaciones Medicas S.C.","GABRIEL BERNAL","Mexico","Mazatlan","Mazatlan"],["Centro de Investigacion Clinica Chapultepec","Misael Tapia Orozco","Mexico","Morelia","Morelia"],["Clinica de Investigacion en Reumatologia y Obesidad S. C.","Aura Garcia Aguilar","Mexico","Guadalajara","Guadalajara"],["GabiPros","Miguel Herrera","Mexico","Mexico City","Mexico City"],["Instituto Jalisciense de Salud Mental","Sergio Villasenor-Bayardo","Mexico","Zapopan","Zapopan"],["Ketamine Clinic México","MANUEL RUIZ FLORES","Mexico","Mexico City","Mexico City"],["Medical Care and Research SA de CV","Enrique Lara González","Mexico","Merida","Merida"],["Scientia Investigacion Clinica S.C.","Rafael Fernández","Mexico","Chihuahua","Chihuahua"],["Centrum Badan Klinicznych PI-House sp. z o.o.","Hanna Badzio-Jagiello","Poland","Gdansk","Gdansk"],["Centrum Medyczne Euromedis","Adam Lopuszko","Poland","Szczecin","Szczecin"],["Centrum Medyczne Ginemedica","Katarzyna Okopien","Poland","Wroclaw","Wroclaw"],["Centrum Medyczne Luxmed","Dariusz Malicki","Poland","Lublin","Lublin"],["Clinhouse Centrum Medyczne","Joanna Moszant","Poland","Zabrze","Zabrze"],["Diamond Clinic","Barbara Rewerska","Poland","Krakow","Krakow"],["Medical Concierge Centrum Medyczne","Marcin Wojnar","Poland","Warsaw","Warsaw"],["MentalMEDIC","Grzegorz Giemza","Poland","Bielsko-Bia？a","Bielsko-Bia？a"],["NZOZ Psychiatrycznej Mentis","Bartlomiej Krzewinski","Poland","Leszno","Leszno"],["Podlaskie Centrum Psychogeriatrii",": Jacek Dobryniewski","Poland","Bia？ystok","Bia？ystok"],["Private Practice - Dr. Ma？gorzata Wojtanowska-Bogacka","Malgorzata Wojtanowska-Bogacka","Poland","Poznan","Poznan"],["Chang Gung Medical Foundation-Linkou Branch","Huang-Li Lin","中国台湾","Taoyuan","Taoyuan"],["Cheng Hsin General Hospital","Tung Ping Su","中国台湾","Taipei","Taipei"],["Chung Shan Medical University Hospital","Po-Chung Ju","中国台湾","Taichung City","Taichung City"],["Keelung Chang Gung Memorial Hospital","Chih-Ken Chen","中国台湾","Keelung","Keelung"],["National Cheng Kung University Hospital","Yen Kuang Yang","中国台湾","TAINAN","TAINAN"],["National Taiwan University Hospital","I-Ming Chen","中国台湾","Taipei","Taipei"],["Taipei Medical University Hospital","Kuo-Hsuan Chung","中国台湾","Taipei","Taipei"],["Taipei Veterans General Hospital","Ya-Mei Bai","中国台湾","Taipei","Taipei"],["Accellacare - Moorpark","Arjun Reyes","United States","California","Moorpark"],["Adams Clinical Boston","Dyanna Domilici","United States","Massachusetts","Boston"],["Adams Clinical Dallas","Benji Kurian","United States","Texas","DeSoto"],["Adams Clinical Harlem","Rachel Noone","United States","New York","New York"],["Adams Clinical Watertown","Daniel Rutrick","United States","Massachusetts","Watertown"],["Alpine Research Organization","Michael Roundy","United States","Utah","Clinton"],["Arch Clinical Trials","Junaid Syed","United States","Missouri","Saint Louis"],["Arcturus Healthcare , PLC, Troy Internal Medicine Research Division","Neil Fraser","United States","Michigan","Troy"],["ATP Clinical Research","Gustavo Alva","United States","California","Orange"],["Cedar Valley Medical Specialists","Saundra Maass-Robinson","United States","Georgia","Decatur"],["Charter Research - Orlando","Jorel Martinez","United States","Florida","Orlando"],["CLA Research","Evelia Iglesias","United States","Florida","Naples"],["Consano Clinical Research, LLC","Michelle Welch","United States","Texas","Shavano Park"],["Encore Medical Research","Alen Hidalgo","United States","Florida","Hollywood"],["Indiana University Health Neuroscience Center","Stephen Strakowski","United States","Indiana","Indianapolis"],["K2 Medical Research - East Providence","john stoukides","United States","Rhode Island","East Providence"],["K2 Medical Research - Maitland","Sejal Patel","United States","Florida","Maitland"],["K2 Medical Research - Tampa","Kelley Wilson","United States","Florida","Tampa"],["Life Medical Research Group Corp","Rafael Conte","United States","Florida","Miami Gardens"],["Northwest Clinical Research Center","Arun Arora","United States","Washington","Bellevue"],["Optimal Research Sites","Antonio Cubano","United States","Florida","Orange City"],["Penn Medicine: University of Pennsylvania Health System","Michael Thase","United States","Pennsylvania","Philadelphia"],["Penn Medicine: University of Pennsylvania Health System","yvette sheline","United States","Pennsylvania","Philadelphia"],["Pharmasite Research, Inc.","Sarah Herts","United States","Maryland","Baltimore"],["Re:Cognition Health","Scott Williams","United States","Virginia","Fairfax"],["Re:Cognition Health - Fort Worth","Lili Meisamy","United States","Texas","Fort Worth"],["SCB Research Center","William Julio","Puerto Rico","Bayamon","Bayamon"],["Suburban Research Associates","Kristen Dopf","United States","Pennsylvania","Media"],["Summit Headlands","Beal Essink","United States","Oregon","Portland"],["Vector Clinical Trials","Ann Childress","United States","Nevada","Las Vegas"],["Yale University School of Medicine","Hilary Blumberg","United States","Connecticut","New Haven"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["首都医科大学附属北京安定医院伦理委员会","修改后同意","2025-09-03"],["首都医科大学附属北京安定医院伦理委员会","同意","2025-12-19"]]

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: 90 ； 国际: 1000 ；
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；