北京Eloralintide注射液III期临床试验-Eloralintide在合并2型糖尿病的肥胖或超重成人参与者的3期研究（ENLIGHTEN-2）

登记号	CTR20260922	试验状态	进行中
申请人联系人	罗兴兴	首次公示信息日期	2026-03-11
申请人名称	Eli Lilly and Company/ 礼来（北京）医学技术创新有限公司/ Incog Biopharma Services, Inc.

登记号	CTR20260922
相关登记号	暂无
药物名称	Eloralintide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	肥胖或者超重
试验专业题目	一项在合并2型糖尿病的肥胖或超重成人参与者中评价Eloralintide每周一次治疗的有效性和安全性的随机、双盲、安慰剂对照3期研究（ENLIGHTEN-2）
试验通俗题目	Eloralintide在合并2型糖尿病的肥胖或超重成人参与者的3期研究（ENLIGHTEN-2）
试验方案编号	J3R-MC-YDAF	方案最新版本号	YDAF(a)
版本日期:	2025-11-13	方案是否为联合用药	否

申请人名称	[["Eli Lilly and Company"],["礼来（北京）医学技术创新有限公司"],["Incog Biopharma Services, Inc."]]
联系人姓名	罗兴兴	联系人座机	021-23020719	联系人手机号	19602108723
联系人Email	luo_xing_xing@lilly.com	联系人邮政地址	上海市-上海市-上海市静安区石门一路288号香港兴业太古汇1座19楼	联系人邮编	200000

证实eloralintide 3 mg、6 mg和/或9 mg组每周一次给药在体重控制方面优效于安慰剂组

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	[["根据世界卫生组织分类或其他当地适用的诊断标准，临床确诊为T2D。"],["筛选前已接受稳定T2D治疗至少90天"],["BMI≥27kg/m2"],["筛选前90天内体重保持稳定（体重变化幅度<5%）。"]]
排除标准	[["既往或计划手术治疗肥胖(但在筛选前>1年接受过脂肪抽吸术、冷冻溶脂、腹壁成形术的参与者允许入组)"],["既往接受过或计划接受针对肥胖的内镜手术和/或器械疗法（如果在筛选前超过6个月已移除器械，则既往器械减重疗法可接受）"],["患有1型糖尿病"],["筛选前90天内接受过以下任何一种降糖药物：胰淀素类似物、GIP/GLP受体激动剂，或胰岛素"],["筛选（访视1）前90天内发生以下任何心血管疾病：急性心肌梗死、脑血管意外（卒中）、冠状动脉血运重建、不稳定型心绞痛，或充血性心力衰竭导致住院"],["有纽约心脏协会心功能分级IV级充血性心力衰竭病史或诊断证明"],["筛选前90天内接受过用于促进减重的处方药或非处方药或替代治疗"]]

试验药	[["中文通用名:NA 英文通用名:Eloralintide 商品名称:NA","剂型:注射液 规格:0.47ml 用法用量:皮下注射，每周一次 用药时程:64周"],["中文通用名:NA 英文通用名:Eloralintide 商品名称:NA","剂型:注射液 规格:0.47ml 用法用量:皮下注射，每周一次 用药时程:64周"],["中文通用名:NA 英文通用名:Eloralintide 商品名称:NA","剂型:注射液 规格:0.47ml 用法用量:皮下注射，每周一次 用药时程:64周"],["中文通用名:NA 英文通用名:Eloralintide 商品名称:NA","剂型:注射液 规格:0.47ml 用法用量:皮下注射，每周一次 用药时程:64周"]] 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:注射液（氯化钠和注射用水） 规格:0.47ml 用法用量:皮下注射，每周一次 用药时程:64周"]] 序号 名称 用法

主要终点指标及评价时间

[["体重较基线的变化百分比","64周","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

[["全身脂肪量的变化百分比","64周","有效性指标"],["腰围变化","64周","有效性指标"],["HbA1c变化","64周","有效性指标"],["甘油三酯变化百分比","64周","有效性指标"],["收缩压变化","64周","有效性指标"],["BMI变化","64周","有效性指标"],["hsCRP的变化百分比","64周","有效性指标"],["空腹胰岛素的变化百分比","64周","有效性指标"],["药物使用的变化","64周","有效性指标"],["eGFR变化","64周","有效性指标"],["SF-36 v2 acute表维度评分和总评分","64周","有效性指标"],["EQ-5D-5L健康状态效用指数值","64周","有效性指标"],["CoEQ评分","64周","有效性指标"],["PGIC体重相关躯体功能改善","64周","有效性指标"],["药代动力学（PK）：稳态时的最高浓度（Cmax,ss）","64周","安全性指标"],["药代动力学（PK）：稳态下一个给药间隔的浓度 时间曲线下面积（AUC(0 τ)ss）","基线至64周","安全性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	纪立农	学位	医学博士	职称	主任医师
	电话	13910978815	Email	jiln@bjmu.edu.cn	邮政地址	北京市-北京市-北京市西城区西直门南大街11号
	邮编	100044	单位名称	北京大学人民医院

[["北京大学人民医院","纪立农","中国","北京市","北京市"],["南京市第一医院","李倩","中国","江苏省","南京市"],["南京医科大学第二附属医院","鲁一兵","中国","江苏省","南京市"],["首都医科大学附属北京潞河医院","赵冬","中国","北京市","北京市"],["天津医科大学第二医院","陈雨","中国","天津市","天津市"],["北京市平谷区医院","李玉凤","中国","北京市","北京市"],["四川省人民医院","田利民","中国","四川省","成都市"],["江西省人民医院","程宗佑","中国","江西省","南昌市"],["自贡市第一人民医院","李健","中国","四川省","自贡市"],["重庆医科大学附属第二医院","刘东方","中国","重庆市","重庆市"],["南方医科大学珠江医院","孙嘉","中国","广东省","广州市"],["上海市嘉定区中心医院","索丽霞","中国","上海市","上海市"],["河南科技大学第一附属医院","姜宏卫","中国","河南省","洛阳市"],["江苏省省级机关医院","唐伟","中国","江苏省","南京市"],["合肥市第二人民医院","叶军","中国","安徽省","合肥市"],["Birmingham Clinical Research","Nova Law","美国","Alabama","Birmingham"],["Cullman Clinical Trials","Randall Quinn","美国","Alabama","Cullman"],["Tucson Clinical Research Institute","Girish Karamchandani","美国","Arizona","Tucson"],["San Fernando Valley Health Institute","Jeffrey London","美国","California","Canoga Park"],["AMCR Institute","Jenine Stone","美国","California","Escondido"],["NorCal Medical Research, Inc","Linda Gaudiani","美国","California","Greenbrae"],["Inglewood Clinical","Maricor Grio","美国","California","Inglewood"],["Ark Clinical Research","Martha Navarro","美国","California","Long Beach"],["Pacific Clinical Studies","Etsegenet Ayele","美国","California","Los Alamitos"],["Care Access - Santa Clarita","Sina Tebi","美国","California","Santa Clarita"],["MUDr. Tomas Edelsberger","Tomas Edelsberger","捷克","Moravian-Silesian Region","Krnov"],["MUDr. Miroslav Koliba s.r.o.","Miroslav Koliba","捷克","Moravian-Silesian Region","Ostrava"],["MUDr. Jana Parkanyiova","Jana Parkanyiova","捷克","Prague","Prague"],["Diabet2 s.r.o., diabetologicka a interni ambulance","Jakub Hron","捷克","Prague","Prague"],["Diabetespraxis Dr. Braun","Hermann Braun","德国","Berlin","Berlin"],["Private Practice - Dr. Kai Konemann & Dr. Henrik Konemann","Kai Koenemann","德国","North Rhine-Westphalia","Bunde"],["InnoDiab Forschung Gmbh","Helga Zeller","德国","North Rhine-Westphalia","Essen"],["Diabetes Zentrum Wilhelmsburg","Peter Witzel","德国","Hamburg","Hamburg"],["Institut fur Diabetesforschung GmbH Munster","Ludger Rose","德国","North Rhine-Westphalia","Munster"],["Schwerpunktpraxis fur Diabetes und Ernahrungsmedizin Dr. med. Winfried Keuthage","Winfried Keuthage","德国","North Rhine-Westphalia","Munster"],["RED-Institut GmbH","Thomas Schaum","德国","Lower Saxony","Oldenburg"],["Life Care Hospital and Research Centre","Sreenivasa Murthy","印度","Karnataka","Bangalore"],["Belagavi Institute of Medical Sciences - Belagavi","Prashantakumar Jaikar","印度","Karnataka","Belgavi"],["Dr. Ram Manohar Lohia Institute of Medical Sciences","Avivar Awasthi","印度","Uttar Pradesh","Lucknow"],["All India Institute of Medical Sciences (AIIMS) - Nagpur","BharatSingh Rathod","印度","Maharashtra","Nagpur"],["Lifepoint Multispeciality Hospital","Amol Dange","印度","Maharashtra","Pune"],["Ashirwad Hospital and Research Centre","Shrikant Deshpande","印度","Maharashtra","Ulhasnagar"],["Hayashi Diabetes Internal Medicine Clinic","Tsutomu Hayashi","日本","Kanagawa Prefecture","Chigasaki"],["Tokyo-Eki Center-building Clinic","Arihiro Kiyosue","日本","Tokyo Metropolis","Chuoku"],["Shonan Takai Clinic","Kuninobu Takai","日本","Kanagawa Prefecture","Kamakura"],["Oishi Clinic","Yayoi Oishi","日本","Fukuoka Prefecture","Kasuya-gun"],["OHAMA Diabetes Clinic","Toshihiko Ohama","日本","Saitama Prefecture","Kawaguchi"],["Higashijujo Sakai Diabetes Internal Medicine Clinic","Koji Sakai","日本","Tokyo Metropolis","Kita-ku"],["Tokuyama Clinic","Takahiko Tokuyama","日本","Chiba Prefecture","Mihama-ku,Chiba City"],["Shinkenko clinic","Yoshiki Shiohira","日本","Okinawa Prefecture","Naha"],["Oyama East Clinic","Kunihiro Suzuki","日本","Tochigi Prefecture","Oyama"],["Shimokitazawa Tomo Clinic","Tomofumi Murakami","日本","Tokyo Metropolis","Setagaya-ku"],["Soka Sugiura Internal Medicine Clinic","Tatsushi Sugiura","日本","Saitama Prefecture","Soka"],["Tsuchiura Medical & Health Care Center","Natsuki Imoto","日本","Ibaraki Prefecture","Tsuchiura"],["Tsuchiura Beryl Clinic","Kota Yamada","日本","Ibaraki Prefecture","Tsuchiura"],["Noritake Clinic","Terumasa Nagase","日本","Ibaraki Prefecture","Ushiku"],["Yokohama Minoru Clinic","Chino Nakamura","日本","Kanagawa Prefecture","Yokohama"],["Centro de Investigacion Medica de Occidente, S.C.","Emilia Pelayo Orozco","墨西哥","Jalisco","Guadalajara"],["Instituto Jalisciense de Investigacion en Diabetes y Obesidad","Guillermo Gonzalez Galvez","墨西哥","Jalisco","Guadalajara"],["Unidad de Investigacion Clinica y Atencion Medica HEPA S.C.","Marisol Herrera Marmolejo","墨西哥","Jalisco","Guadalajara"],["Medical Care and Research SA de CV","Jose Cetina Canto","墨西哥","Yucatan","Merida"],["Cardiolink Clin Trials","Elias Alberto Garcia Cantu","墨西哥","Nuevo Leon","Monterrey"],["Niepubliczny Specjalistyczny Zaklad Opieki Zdrowotnej Osrodek Diabetologiczny Popula Spolka Cywilna","Grazyna Laszewska","波兰","Podlaskie","Bialystok"],["Centrum Medyczne NEUROMED","Beata Lisewska","波兰","Kuyavian-Pomeranian","Bydgoszcz"],["Ambulatorium Sp. z o.o.","Anna Bazela-Ostromecka","波兰","Warmian-Masurian","Elblag"],["Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET","Joanna Mirocka","波兰","Lesser Poland (Malopolskie)","Krakow"],["Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna","Malgorzata Jozefowska","波兰","Lodz","Lodz"],["Ekamed","Ewa Skokowska","波兰","Lublin","Lublin"],["NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki","Henryk Rudzki","波兰","Silesian","Ruda Slaska"],["Samodzielny Publiczny Szpital Kliniczny nr 1 SUM","Janusz Gumprecht","波兰","Silesian","Zabrze"],["Centro de Endocrinologia y Nutricion","Juan Otero-Martinez","波多黎各","Puerto Rico","Caguas"],["Dorado Medical Complex","Luis Pagan-Cardona","波多黎各","Puerto Rico","Dorado"],["Diacrin s.r.o.","Eva Zakovicova","斯洛伐克","Bratislava Region","Bratislava"],["MediVet s.r.o.","Eva Pavleova","斯洛伐克","Bratislava Region","Malacky"],["B-Medical, s.r.o.","Maria Balekova","斯洛伐克","Zilina Region","Namestovo"],["FUNKYSTUFF s.r.o.","Miriam Teplanova","斯洛伐克","Nitra Region","Nove Zamky"],["DIA-MED CENTRUM s.r.o.","Ludmila Kubincova","斯洛伐克","Trencin Region","Puchov"],["MEDI-DIA s.r.o.","Martina Merciakova","斯洛伐克","Presov Region","Sabinov"],["Korea University Ansan Hospital","NANHEE KIM","韩国","Gyeonggi-do","Ansan-si"],["The Catholic University of Korea, Bucheon St. Mary's Hospital","Sung-Rae Kim","韩国","Gyeonggi-do","Bucheon-si"],["Hanyang University Guri Hospital","Chang Beom Lee","韩国","Gyeonggi-do","Guri-si"],["Chosun University Hospital","Sang Yong Kim","韩国","Gwangju Metropolitan City","Gwangju"],["Seoul National University Bundang Hospital","Soo Lim","韩国","Gyeonggi-do","Seongnam"],["Severance Hospital, Yonsei University Health System","Byung Wan Lee","韩国","Seoul Special City","Seoul"],["Hospital Universitario de La Ribera","carmen fajardo","西班牙","Valencia","Alzira"],["Hospital Universitari Vall d'Hebron","ANDREEA CIUDIN","西班牙","Barcelona (Catalonia)","Barcelona"],["Hospital Clinic de Barcelona","Ana de Hollanda","西班牙","Barcelona (Catalonia)","Barcelona"],["Complejo Hospitalario Ruber Juan Bravo","Esteban Jodar Gimeno","西班牙","Community of Madrid","Madrid"],["H.R.U Malaga - Hospital Civil","GABRIEL OLVEIRA","西班牙","Malaga (Andalusia)","Malaga"],["Hospital Universitario Virgen de la Victoria","Francisco Tinahones Madueno","西班牙","Malaga (Andalusia)","Malaga"],["Centro Medico Compostela","Maria Gemma Rodriguez-Carnero","西班牙","A Coruna (Galicia)","Santiago de Compostela"],["Hospital Universitario Virgen Del Rocio","Virginia Bellido","西班牙","Sevilla (Andalusia)","Seville"],["Vithas Hospital Sevilla","Cristobal Morales Portillo","西班牙","Sevilla (Andalusia)","Seville"],["Kaohsiung Medical University Chung-Ho Memorial Hospital","Tsung-Hsien Lin","中国台湾","Kaohsiung","Kaohsiung City"],["Chang Gung Memorial Hospital at Kaohsiung","Jung-Fu Chen","中国台湾","Kaohsiung","Kaohsiung Niao Sung Dist"],["National Taiwan University Hospital","Chih-Yuan Wang","中国台湾","Taipei","Taipei"],["Taipei Veterans General Hospital","Chii-Min Hwu","中国台湾","Taipei","Taipei"],["Chang Gung Medical Foundation-Linkou Branch","Chia-Hung Lin","中国台湾","Taoyuan","Taoyuan District"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["北京大学人民医院伦理审查委员会","同意","2026-01-19"]]

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: 80 ； 国际: 1035 ；
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：2025-12-15；
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；