北京AMG133III期临床试验-Maridebart Cafraglutide 治疗射血分数保留的或轻度降低的心力衰竭合并肥胖（MARITIME-HF）

登记号	CTR20253469	试验状态	进行中
申请人联系人	王宏亮	首次公示信息日期	2025-08-27
申请人名称	Amgen Inc./ 安进生物技术咨询（上海）有限公司/ Amgen Inc.；Amgen Europe B.V.

登记号	CTR20253469
相关登记号	暂无
药物名称	AMG 133
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	心力衰竭合并肥胖
试验专业题目	评价Maridebart Cafraglutide 在射血分数保留的或轻度降低的心力衰竭合并肥胖的参与者中对死亡率和发病率影响的疗效和安全性的随机、双盲、安慰剂对照、III 期研究（MARITIME-HF）
试验通俗题目	Maridebart Cafraglutide 治疗射血分数保留的或轻度降低的心力衰竭合并肥胖（MARITIME-HF）
试验方案编号	20230227	方案最新版本号	原始版本
版本日期:	2025-05-08	方案是否为联合用药	否

申请人名称	[["Amgen Inc."],["安进生物技术咨询（上海）有限公司"],["Amgen Inc.；Amgen Europe B.V."]]
联系人姓名	王宏亮	联系人座机	021-23168666	联系人手机号	15910452941
联系人Email	hwang22@amgen.com	联系人邮政地址	上海市-上海市-黄浦区太仓路233号18F新茂大厦	联系人邮编	200020

在射血分数保留的或轻度降低的心力衰竭合并肥胖的参与者中评价Maridebart Cafraglutide对死亡率和发病率影响的疗效和安全性。

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	双盲	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	[["年龄 ≥ 18 岁。"],["体重指数（BMI）≥ 30 kg/m2。"],["在筛查前至少 30 天被诊断为心力衰竭（HF），纽约心脏病协会（NYHA）分级为 II-IV 级。"],["接受标准的心力衰竭治疗。"],["左心室射血分数（LVEF）> 40%。"],["NT-proBNP 升高。"]]
排除标准	[["筛查前 60 天内有以下任一病史：I 型（自发性）心肌梗死、心脏瓣膜置换或修复、冠状动脉血运重建、冠状动脉旁路移植术或其他重大心血管手术、中风。"],["心力衰竭由以下原因引起：肥厚型心肌病、浸润性心肌病、活动性心肌炎、缩窄性心包炎、心包填塞、致心律失常性右心室或左心室心肌病/发育不良、未经矫正的原发性心脏瓣膜病，或临床意义的先天性心脏病。"],["1 型糖尿病，或除 2 型糖尿病（T2DM）或妊娠期糖尿病以外的其他任何类型糖尿病。"],["对于筛查时已确诊为 T2DM 的受试者：nHbA1c > 10.0%n糖尿病控制不良，需立即治疗n有糖尿病酮症酸中毒或高渗状态/高渗性昏迷病史n筛查前 6 个月内有一次或多次重度低血糖，和/或有无知觉性（未察觉的）低血糖病史n有增殖性糖尿病视网膜病变病史、糖尿病性黄斑病变病史或重度非增殖性糖尿病视网膜病变病史。"],["收缩压（SBP）≥ 180 mmHg，或正在使用三种或以上降压药物且 SBP > 160 mmHg。"],["有慢性或筛查前 180 天内急性胰腺炎病史。"],["有甲状腺髓样癌或2型多发性内分泌腺瘤病 （MEN-2）的家族史或个人史。"],["急性或慢性肝炎。"],["以下任一精神病史：n筛查前 2 年内有不稳定的重度抑郁症或其他重度精神疾病病史n过去曾试图自杀n筛查前 5 年内有非自杀性自我伤害史。"],["有任何其他可能使受试者无法遵循方案或完成研究的疾病史（由研究者判断）。"],["随机分组前 90 天内使用过或计划在研究期间使用胰高血糖素样肽-1 受体激动剂（GLP-1 RA）、葡萄糖依赖性促胰岛素多肽（GIP）激动剂或拮抗剂，或胰淀素类似物。"]]

试验药	[["中文通用名:NA 英文通用名:MaridebartCafraglutide 商品名称:NA","剂型:预充式注射器 规格:21mg/35mg/70mg/140mg/210mg/350mg 用法用量:350mg,Q4W（每四周一次），皮下注射 用药时程:大约59个月（包含双盲期35个月和开放期24个月）"]] 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:无","剂型:预充式注射器 规格:NA 用法用量:Q4W（每四周一次），皮下注射 用药时程:大约35个月（双盲期）"]] 序号 名称 用法

主要终点指标及评价时间	[["由CV死亡或HF事件组成的复合终点首次出现的时间","长达约35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	[["基线KCCQ-CSS评分≤80的参与者的KCCQ症状总分（TSS）与基线相比的变化","基线期和W48","有效性指标"],["包括首次和复发性心力衰竭事件在内的心力衰竭事件总数","长达约35个月","有效性指标"],["复合肾病终点的首次事件时间","长达约35个月","安全性指标"],["eGFR斜率变化（总计）","从基线至长达约35个月","安全性指标"],["eGFR斜率变化（慢性）","从4个月至长达约35个月","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	张宇辉	学位	医学博士	职称	主任医师
	电话	010-8832267	Email	yuhuizhangjoy@163.com	邮政地址	北京市-北京市-西城区北礼士路167号
	邮编	100037	单位名称	中国医学科学院阜外医院

[["中国医学科学院阜外医院","张宇辉","中国","北京市","北京市"],["哈尔滨医科大学附属第一医院","富路","中国","黑龙江省","哈尔滨市"],["济南市中心医院","苏国海","中国","山东省","济南市"],["天津市人民医院","魏丽萍","中国","天津市","天津市"],["吉林省人民医院","张雪莲","中国","吉林省","长春市"],["陕西省人民医院","吕颖","中国","陕西省","西安市"],["内蒙古科技大学包头医学院第一附属医院","裴汉军","中国","内蒙古自治区","包头市"],["辽宁省人民医院","侯爱洁","中国","辽宁省","沈阳市"],["西安交通大学第一附属医院","袁祖贻","中国","陕西省","西安市"],["河南大学淮河医院","何瑞利","中国","河南省","开封市"],["山西省心血管病医院","王敬萍","中国","山西省","太原市"],["河北医科大学第二医院","鲁静朝","中国","河北省","石家庄市"],["吉林大学第一医院","沈波涛","中国","吉林省","长春市"],["南昌大学第一附属医院","彭小平","中国","江西省","南昌市"],["秦皇岛市第一医院","赵君","中国","河北省","秦皇岛市"],["北京医院","于雪","中国","北京市","北京市"],["重庆医科大学附属第二医院","凌智瑜","中国","重庆市","重庆市"],["萍乡市人民医院","张雨虹","中国","江西省","萍乡市"],["吉林大学中日联谊医院","贺玉泉","中国","吉林省","长春市"],["西安医学院第一附属医院","蔡天志","中国","陕西省","西安市"],["洛阳市第三人民医院（洛阳职业技术学院第一附属医院","李立鹏","中国","河南省","洛阳市"],["南京市江宁医院","张郁青","中国","江苏省","南京市"],["上海市东方医院","张奇","中国","上海市","上海市"],["首都医科大学附属北京友谊医院","邱惠","中国","北京市","北京市"],["赤峰学院附属医院","祁宏","中国","内蒙古自治区","赤峰市"],["广东省人民医院","王玲","中国","广东省","广州市"],["湖北省第三人民医院","张璟轶","中国","湖北省","武汉市"],["南京医科大学第二附属医院","章海燕","中国","江苏省","南京市"],["成都市第五人民医院","王剑峰","中国","四川省","成都市"],["郑州大学第一附属医院","张金盈","中国","河南省","郑州市"],["中南大学湘雅二医院","陈雅琴","中国","湖南省","长沙市"],["北京大学第三医院","邵春丽","中国","北京市","北京市"],["大连大学附属中山医院","于勤","中国","辽宁省","大连市"],["上海市第一人民医院","杨文艺","中国","上海市","上海市"],["无锡市人民医院","陈茂华","中国","江苏省","无锡市"],["内蒙古医科大学附属医院","张越","中国","内蒙古自治区","呼和浩特市"],["长沙市第三医院","张育民","中国","湖南省","长沙市"],["河北省人民医院","党懿","中国","河北省","石家庄市"],["武汉大学人民医院","邓伟","中国","湖北省","武汉市"],["安徽医科大学第二附属医院","盛建龙","中国","安徽省","合肥市"],["丽水市中心医院","吕玲春","中国","浙江省","丽水市"],["山西省运城市中心医院","屈艳玲","中国","山西省","运城市"],["山西医科大学第一医院","陈还珍","中国","山西省","太原市"],["吉林大学第二医院","刘斌","中国","吉林省","长春市"],["东南大学附属中大医院","张晓黎","中国","江苏省","南京市"],["常州市第一人民医院","杨玲","中国","江苏省","常州市"],["四平市中心人民医院","苏丽军","中国","吉林省","四平市"],["浙江大学医学院附属第一医院","胡晓晟","中国","浙江省","杭州市"],["中南大学湘雅三医院","张志辉","中国","湖南省","长沙市"],["浙江大学医学院附属邵逸夫医院","傅国胜","中国","浙江省","杭州市"],["Prince of Wales Hospital, Chinese University of Hong Kong","Tan Guang Ming","中国香港","香港特别行政区","香港特别行政区"],["Queen Mary Hospital, The University of Hong Kong","Tse Hung Fat","中国香港","香港特别行政区","香港特别行政区"],["National Taiwan University Hospital","KaotHsien-Li","中国台湾","台北市","台北市"],["Taipei Veterans General Hospital","SungtShih-Hsien","中国台湾","台北市","台北市"],["Cemedic Centro de Especialidades Medicas","Majul Claudio Rodolfo","阿根廷","布宜诺斯艾利斯省","布宜诺斯艾利斯自治市"],["Centro de Investigaciones Metabolicas Cinme","Herrera Paz Juan Jose","阿根廷","布宜诺斯艾利斯省","布宜诺斯艾利斯自治市"],["Core Research Group Pty Ltd","Colquhoun David","澳大利亚","昆士兰州","Milton"],["Flinders Medical Centre","Selvanayagam Joseph","澳大利亚","南澳大利亚州","Fullarton"],["Universitaetsklinikum Allgemeines Krankenhaus Wien","Zelniker Thomas","奥地利","Wien","Wien"],["Landeskrankenhaus Salzburg","Lichtenauer Michael","奥地利","Salzburg","Salzburg"],["Jessa Ziekenhuis - Campus Virga Jesse","Verwerft Jan","比利时","Hasselt","Hasselt"],["Ziekenhuis Oost-Limburg - Campus Sint-Jan","Martens Pieter","比利时","Genk","Genk"],["Hospital de Base de Sao Jose do Rio Preto","Nigro MaiatLilia","巴西","圣保罗","Sao Jose do Rio Preto"],["IBPClin Instituto Brasil de Pesquisa Clinica","Scaf Cristiane","巴西","里约热内卢","Rio de Janeiro"],["Diagnostic-Consultative Center Alexandrovska EOOD","Runev Nikolay","保加利亚","Sofia","Sofia"],["Multiprofile Regional Hospital for Active Treatment Dr Stefan Cherkezov AD","GorchevatVanya Mancheva","保加利亚","Veliko Tarnovo","Veliko Tarnovo"],["Saul Vizel Professional Medicine Corporation – Vizel Cardiac Research","Vizel Saul","加拿大","安大略省","Cambridge"],["Partners in Advanced Cardiac Evaluation","Khaykin Yaariv","加拿大","安大略省","Newmarket"],["Oncocentro Apys","Novajas Balboa Manuel Enrique","智利","瓦尔帕莱索","Vina del Mar"],["Clinical Research Chile SpA","Mellado Cofre Sergio Adrian","智利","Valdivia","Valdivia"],["Instituicion Prestadora de Salud Centro Cientifico Asistencial SAS","Buelvas Herazo Jannes Jose","哥伦比亚","大西洋省","Barranquilla"],["Centro de Investigaciones Clinicas SAS","Arana Londono Camilo","哥伦比亚","巴兰基亚","Santiago de Cali"],["MUDr Libor Nechvatal sro","Nechvatal Libor","捷克共和国","Brno","Brno"],["MUDr Karel Kamenik sro","Ludka Ondrej","捷克共和国","Brno","Brno"],["Aarhus Universitetshospital","Kjaerulf Jensen Henrik","丹麦","Aarhus N","Aarhus N"],["Herlev and Gentofte Hospital","Schout Morten","丹麦","Herlev","Herlev"],["Helsinki University Hospital","Sinisalo Juha","芬兰","Helsinki","Helsinki"],["Turku University Hospital Tyks","Saraste Antti","芬兰","Turku","Turku"],["Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil","Galinier Michel","法国","Toulouse Cedex 9","Toulouse Cedex 9"],["Centre Hospitalier Universitaire de Montpellier - Hopital Arnaud de Villeneuve","Roubille Francois","法国","oyen Gaston Giraud Montpellier","oyen Gaston Giraud Montpellier"],["Kardiologische Gemeinschaftspraxis Papenburg","WilketAndreas","德国","Papenburg","Papenburg"],["Charite – Universitaetsmedizin Berlin, Campus Benjamin Franklin","Rauch Kroehnert Ursula","德国","Berlin","Berlin"],["Attikon Hospital","Filippatos Gerasimos","希腊","Athens","Athens"],["General Hospital of Athens Ippokrateio","Tsioufis Konstantinos","希腊","Athens","Athens"],["Semmelweis Egyetem Varosmajori Sziv- es Ergyogyaszati Klinika","Merkely Bela","匈牙利","Budapest","Budapest"],["Fejer Varmegyei Szent Gyorgy Egyetemi Oktato Korhaz","NooritEbrahim","匈牙利","Szekesfehervar","Szekesfehervar"],["Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii","SennitMichele","意大利","Bergamo","Bergamo"],["Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia","Inciardi Riccardo Maria","意大利","Brescia","Brescia"],["Miyanosawa Clinic of Internal Medicine and Cardiology","SatohtShinichiro","日本","北海道","6jo Nishi-kuSapporo-shi"],["Sanin Rosai Hospital","Mizuta Einosuke","日本","Tottori","Yonago-shi"],["Virgen Cardiovascular Research SC","Virgen Carrillo Luis Ramon","墨西哥","Guadalajara","Jalisco"],["Cardiolink Clin Trials","Garcia Cantu Elias Alberto","墨西哥","Nuevo León","Monterrey"],["Albert Schweitzer Ziekenhuis, Locatie Dordwijk","Van Gent Marco","荷兰","Dordrecht","Dordrecht"],["Amphia ziekenhuis","Schaap Jeroen","荷兰","Dordrecht","Dordrecht"],["Medicome Spolka z Ograniczona Odpowiedzialnoscia","Kobielusz-Gembala Iwona","波兰","Oswiecim","Oswiecim"],["Centrum Medyczne Medyk Spolka z Ograniczona Odpowiedzialnoscia Spolka Komandytowa","Mazur Stanislaw","波兰","Rzeszow","Rzeszow"],["Unidade Local de Saude de Coimbra, EPE","Monteiro Pedro","葡萄牙","Coimbra","Coimbra"],["Unidade Local de Saude de Santa Maria, EPE - Hospital de Santa Maria","Caldeira Daniel","葡萄牙","Lisboa","Lisboa"],["Cabinet Medical Individual Dr Podoleanu Cristian","Podoleanu Cristian Gheorghe","罗马尼亚","Targu Mures","Targu Mures"],["Sal Med SRL","Universitaetsspital Basel","罗马尼亚","Pitesti","Pitesti"],["Cardio D and R, sro Kosice","Fedacko Jan","斯洛伐克","Kosice","Kosice"],["Alian, sro","Dzupina Andrej","斯洛伐克","Bardejov","Bardejov"],["Seoul National University Hospital","Lee Hae-Young","韩国","Seoul","Seoul"],["Seoul National University Bundang瑞典 Hospital","ChoitDong-Ju","韩国","Seongnam-si, Gyeonggi-do","Seongnam-si, Gyeonggi-do"],["Hospital Universitario Virgen de la Arrixaca","Pascual Figal Domingo Andres","西班牙","Murcia","El Palmar"],["Hospital Universitario La Paz","Moreno Gomez Jose Raul","西班牙","Madrid","Madrid"],["Karolinska Universitetssjukhuset Solna","LundtLars","瑞典","Solna","Solna"],["Clemenstorgets Hjartmottagning","Lindholm Carl-Johan","瑞典","Lund","Lund"],["Universitaetsspital Basel","Mueller Christian","瑞士","Basel","Basel"],["Inselspital Bern","Hunziker Munsch Lukas","瑞士","Bern","Bern"],["Afyonkarahisar Saglik Bilimleri Universitesi Hastanesi","OnrattErsel","土耳其","Afyonkarahisar","Afyonkarahisar"],["Ankara Bilkent Sehir Hastanesi","Balci Kevser Gulcihan","土耳其","Ankara","Ankara"],["Wycombe Hospital","Clifford Piers","英国","High Wycombe","High Wycombe"],["Newcastle NIHR Commercial Research Delivery Centre","Kunadian Vijay","英国","Newcastle Upon Tyne","Newcastle Upon Tyne"],["SEC Clinical Research","Muench Andreas","美国","亚拉巴马州","Dothan"],["Eastern Shore Research Institute","Pursley Michael","美国","亚拉巴马州","Fairhope"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["中国医学科学院阜外医院伦理委员会","同意","2025-07-10"]]

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: 120 ； 国际: 5056 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 2 ；
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：2025-06-19；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：2025-06-25；
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；