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Orforglipron (LY3502970) 在肥胖或超重伴有体重相关合并症的成人参与者中的研究 (ATTAIN-1)

2026年7月23日 更新者：Eli Lilly and Company

一项 3 期随机双盲研究，旨在研究每日一次口服 LY3502970 与安慰剂相比对患有肥胖或超重并伴有体重相关合并症的成人参与者的疗效和安全性 (ATTAIN-1)

本研究将调查每日一次口服奥福列普隆对肥胖或超重伴有体重相关合并症的成年参与者的疗效和安全性。

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

3127

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 中国
    • Anhui
      • Hefei、Anhui、中国、230011
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100853
        • Chinese PLA General Hospital
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、404117
        • Chongqing General Hospital
    • Guangdong
      • Shenzhen、Guangdong、中国、518020
        • Shenzhen People's Hospital
    • Hainan
      • Haikou、Hainan、中国、570311
        • Hainan General Hospital
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Luoyang Shi、Henan、中国、471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou、Henan、中国、450014
        • The Second Affiliated Hospital of Zhengzhou University
    • Jiangsu
      • Nanjing、Jiangsu、中国、210006
        • Nanjing First Hospital
      • Nanjing、Jiangsu、中国、210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Suzhou、Jiangsu、中国、215006
        • The First Affiliated Hospital of Soochow University
      • Zhenjiang、Jiangsu、中国、212000
        • Affiliated Hospital of Jiangsu University
    • Jiangxi
      • Nanchang、Jiangxi、中国、330006
        • Jiangxi Provincial People's Hospital
    • Shandong
      • Jinan、Shandong、中国、250013
        • Jinan Central Hospital
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、201800
        • Jiading District Central Hospital
    • Tianjin Municipality
      • Tianjin、Tianjin Municipality、中国、300052
        • Tianjin Medical University General Hospital
      • Tianjin、Tianjin Municipality、中国、300134
        • Tianjin Medical University Zhu Xianyi Memorial Hospital
    • Yunnan
      • Kunming、Yunnan、中国、650034
        • The First People's Hospital of Yunnan Province
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310013
        • Zhejiang Hospital
      • Ningbo、Zhejiang、中国、315010
        • Ningbo First Hospital
  • 印度
    • Andhra Pradesh
      • Guntur、Andhra Pradesh、印度、522001
        • Endolife Speciality Hospitals
    • Karnataka
      • Bangalore、Karnataka、印度、560002
        • Victoria Hospital, Bangalore Medical College And Research Institute
      • Mysore、Karnataka、印度、570001
        • Mysore Medical College
    • Maharashtra
      • Nagpur、Maharashtra、印度、441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
      • Nagpur、Maharashtra、印度、440015
        • Central India Cardiology and Research Institute
      • Pune、Maharashtra、印度、411004
        • Deenanath Mangeshkar Hospital & Research Centre
      • Pune、Maharashtra、印度、411004
        • Sahyadri Super Speciality Hospital
      • Pune、Maharashtra、印度、411057
        • Lifepoint Multispeciality Hospital
  • 台湾
      • Changhua、台湾、50006
        • Changhua Christian Hospital
      • Kaohsiung City、台湾、807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Tainan、台湾、704
        • National Cheng Kung University Hospital
    • Chiayi
      • Chiayi City、Chiayi、台湾、600
        • Chiayi Christian Hospital
    • Kaohsiung
      • Kaohsiung Niao Sung Dist、Kaohsiung、台湾、83301
        • Chang Gung Memorial Hospital at Kaohsiung
  • 巴西
      • Rio de Janeiro、巴西、22061-080
        • Hospital São Lucas de Copacabana
      • São Paulo、巴西、01228-000
        • CPQuali Pesquisa Clínica
      • São Paulo、巴西、04266-010
        • CEPIC - Centro Paulista de Investigação Clínica
      • São Paulo、巴西、05403-000
        • Hospital das Clinicas FMUSP
    • Ceará
      • Fortaleza、Ceará、巴西、60430-350
        • Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas
    • Espírito Santo
      • Vitória、Espírito Santo、巴西、29055450
        • CEDOES
    • Maranhão
      • Bequimão、Maranhão、巴西、65060-645
        • Hospital Sao Domingos
    • Paraná
      • Curitiba、Paraná、巴西、80030-480
        • Cline Research Center
      • Curitiba、Paraná、巴西、80045170
        • Quanta Diagnóstico e Terapia
    • Rio Grande do Sul
      • Porto Alegre、Rio Grande do Sul、巴西、90430-001
        • Nucleo de Pesquisa Clinica do Rio Grande do Sul
    • São Paulo
      • Campinas、São Paulo、巴西、13060-803
        • Centro de Pesquisa São Lucas
      • Jaú、São Paulo、巴西、17201130
        • CECIP - Centro de Estudos do Interior Paulista
      • São Bernardo do Campo、São Paulo、巴西、09715-090
        • Centro Multidisciplinar de Estudos Clinicos
      • Votuporanga、São Paulo、巴西、15501-405
        • Integral Pesquisa e Ensino
  • 斯洛伐克
      • Bratislava、斯洛伐克、831 03
        • MediTask
    • Banská Bystrica Region
      • Lučenec、Banská Bystrica Region、斯洛伐克、984 01
        • Nemocnica s poliklinikou Lucenec
    • Bratislava Region
      • Bratislava、Bratislava Region、斯洛伐克、811 08
        • Metabol KLINIK
    • Košice Region
      • Košice、Košice Region、斯洛伐克、04001
        • Human Care s.r.o.
      • Trebišov、Košice Region、斯洛伐克、075 01
        • ARETEUS s.r.o.
    • Košický Kr
      • Rožňava、Košický Kr、斯洛伐克、048 01
        • DIAB sro
    • Presov
      • Sabinov、Presov、斯洛伐克、083 01
        • MEDI-DIA s.r.o.
    • Trenčín Region
      • Púchov、Trenčín Region、斯洛伐克、020 01
        • DIA-MED CENTRUM s.r.o.
  • 日本
      • Fukuoka、日本、812-0025
        • Boocs Clinic Fukuoka
      • Osaka、日本、530-0001
        • Osaka Nishiumeda Clinic
    • Fukuoka
      • Wakasugi、Fukuoka、日本、811-2310
        • Oishi Clinic
    • Hiroshima
      • Aki-gun、Hiroshima、日本、735-0017
        • Mazda Hospital
    • Ibaraki
      • Tsuchiura、Ibaraki、日本、300-0012
        • Tsuchiura Medical & Health Care Center
    • Kagawa-ken
      • Takamatsu、Kagawa-ken、日本、760-0076
        • NTT Nishinihon Takamatsu Clinic
      • Zentsujichó、Kagawa-ken、日本、765-0071
        • Iwamoto Internal Medicine Clinic
    • Kanagawa
      • Yokohama、Kanagawa、日本、232-0064
        • Yokohama Minoru Clinic
    • Osaka
      • Suita-shi、Osaka、日本、565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Saitama
      • Sōka、Saitama、日本、340-0015
        • Sugiura Internal Medicine Clinic
    • Tokyo
      • Adachi-ku、Tokyo、日本、120-0022
        • Adachi Kyosai Hospital
      • Chuo-ku、Tokyo、日本、103-0027
        • Tokyo-Eki Center-building Clinic
      • Chuo-ku、Tokyo、日本、104-0031
        • Fukuwa Clinic
      • Chuo-ku、Tokyo、日本、103-0027
        • Medical Corporation Chiseikai Tokyo Center Clinic
      • Meguro-ku、Tokyo、日本、153-0053
        • Yutenji Medical Clinic
      • Mitaka、Tokyo、日本、181-0013
        • Kanno Naika
      • Setagaya-ku、Tokyo、日本、155-0031
        • Shimokitazawa Tomo Clinic
      • Shinjuku-ku、Tokyo、日本、160-0008
        • Heishinkai Medical Group ToCROM Clinic
  • 波多黎各
      • Dorado、波多黎各、00646
        • Dorado Medical Complex
    • PR
      • San Juan、PR、波多黎各、00917
        • GCM Medical Group, PSC - Hato Rey Site
  • 美国
    • Arizona
      • Chandler、Arizona、美国、85225
        • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
      • Sun City West、Arizona、美国、85375
        • Clinical Research Institute of Arizona (CRI) - Sun City West
    • California
      • Concord、California、美国、94520
        • John Muir Physician Network Research Center
      • Escondido、California、美国、92025
        • AMCR Institute
      • Greenbrae、California、美国、94904
        • NorCal Medical Research, Inc
      • Huntington Park、California、美国、90255
        • Velocity Clinical Research, Huntington Park
      • Los Angeles、California、美国、90057
        • Velocity Clinical Research, Westlake
      • Montclair、California、美国、91763
        • Catalina Research Institute, LLC
      • San Ramon、California、美国、94583
        • Norcal Endocrinology & Internal Medicine
      • Tustin、California、美国、92780
        • University Clinical Investigators, Inc.
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Anschutz Medical Campus
    • Florida
      • Miami、Florida、美国、33186
        • New Age Medical Research Corporation
      • Miramar、Florida、美国、33027
        • South Broward Research
      • Ocala、Florida、美国、34470
        • Renstar Medical Research
      • Tampa、Florida、美国、33619
        • Jedidiah Clinical Research - Tampa - Bay Plaza
      • Winter Park、Florida、美国、32789
        • Clinical Site Partners, LLC dba Flourish Research
    • Georgia
      • Lawrenceville、Georgia、美国、30046
        • Physicians Research Associates
      • Macon、Georgia、美国、31210
        • East Coast Institute for Research, LLC
      • Union City、Georgia、美国、30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Hawaii
      • Honolulu、Hawaii、美国、96814
        • East-West Medical Research Institute
    • Idaho
      • Blackfoot、Idaho、美国、83221
        • Elite Clinical Trials
    • Kansas
      • Topeka、Kansas、美国、66606
        • Cotton O'Neil Clinical Research Center
      • Topeka、Kansas、美国、66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Louisiana
      • Baton Rouge、Louisiana、美国、70808
        • Pennington Biomedical Research Center
      • Lake Charles、Louisiana、美国、70601
        • Care Access - Lake Charles
    • Maryland
      • Hyattsville、Maryland、美国、20782
        • MedStar Health Research Institute (MedStar Physician Based Research Network)
      • Rockville、Maryland、美国、20852
        • Endocrine and Metabolic Consultants
    • Michigan
      • Troy、Michigan、美国、48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Mississippi
      • Ridgeland、Mississippi、美国、39157
        • SKY Integrative Medical Center/SKYCRNG
    • Nevada
      • Las Vegas、Nevada、美国、89128
        • Las Vegas Medical Research
    • New York
      • Lake Success、New York、美国、11042
        • Long Island Cardiovascular Consultants
      • New York、New York、美国、10021
        • Weill Cornell Medical College
    • Oklahoma
      • Norman、Oklahoma、美国、73069
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Austin、Texas、美国、78731
        • Texas Diabetes & Endocrinology, P.A.
      • Dallas、Texas、美国、75251
        • Cedar Health Research
      • Dallas、Texas、美国、75230
        • Velocity Clinical Research, Dallas
      • Dallas、Texas、美国、75208
        • Thyroid, Endocrinology, and Diabetes
      • Houston、Texas、美国、77054
        • Juno Research
      • Shavano Park、Texas、美国、78231
        • Consano Clinical Research, LLC
      • Wylie、Texas、美国、75098
        • Soma Clinical Trials
    • Utah
      • Draper、Utah、美国、84020
        • Physicians' Research Options
    • Virginia
      • Newport News、Virginia、美国、23606
        • Health Research of Hampton Roads, Inc.
    • Washington
      • Redmond、Washington、美国、98052
        • Eastside Research Associates
  • 西班牙
      • Valencia、西班牙、46026
        • Hospital Universitari i Politecnic La Fe
    • A Coruña [La Coruña]
      • A Coruña、A Coruña [La Coruña]、西班牙、15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña
      • Ferrol、A Coruña [La Coruña]、西班牙、15405
        • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
    • Almería
      • Almería、Almería、西班牙、04009
        • Centro Periferico de Especialidades Bola Azul
    • Andalusia
      • Málaga、Andalusia、西班牙、29010
        • Hospital Universitario Virgen de la Victoria
      • Seville、Andalusia、西班牙、41010
        • Hospital Quiron Infanta Luisa
    • Barcelona [Barcelona]
      • Badalona、Barcelona [Barcelona]、西班牙、08916
        • Hospital Germans Trías i Pujol
      • Barcelona、Barcelona [Barcelona]、西班牙、08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona、Barcelona [Barcelona]、西班牙、08022
        • Centro Medico Teknon
    • Castille and León
      • Valladolid、Castille and León、西班牙、47010
        • Hospital Clínico Universitario de Valladolid
    • Cádiz
      • Sanlúcar de Barrameda、Cádiz、西班牙、11540
        • Hospital Virgen del Camino
      • Villamartín、Cádiz、西班牙、11650
        • Hospital Virgen de las Montañas
    • Valenciana, Comunitat
      • Valencia、Valenciana, Comunitat、西班牙、46014
        • Hospital General Universitario de Valencia
  • 韩国
    • Incheon-gw
      • Namdong-gu、Incheon-gw、韩国、21565
        • Gachon University Gil Medical Center
    • Kyǒnggi-do
      • Ansan-si、Kyǒnggi-do、韩国、15355
        • Korea University Ansan Hospital
      • Anyang-si、Kyǒnggi-do、韩国、14068
        • Hallym University Sacred Heart Hospital
      • Suwon、Kyǒnggi-do、韩国、16499
        • Ajou University Hospital
    • Kyǒngsangnam-do
      • Busan、Kyǒngsangnam-do、韩国、50612
        • Pusan National University Yangsan Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul、Seoul-teukbyeolsi [Seoul]、韩国、03080
        • Seoul National University Hospital
    • Taejǒn-Kwangyǒkshi
      • Seogu、Taejǒn-Kwangyǒkshi、韩国、35365
        • Konyang University Hospital

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 有体重指数

    • ≥30.0千克/平方米（kg/m²），

    • ≥27.0 kg/m² 并且在筛选时存在至少一种以下与体重相关的合并症（治疗或未治疗）：

      • 高血压、血脂异常、阻塞性睡眠呼吸暂停、心血管疾病（例如，缺血性心血管疾病、纽约心脏协会功能性 I-III 级心力衰竭）。
  • 有至少 1 次自我报告的节食减肥失败史。

排除标准：

  • 患有 1 型糖尿病、2 型糖尿病或任何其他类型的糖尿病、酮症酸中毒史或高渗状态/昏迷
  • 筛选前 90 天内自我报告的体重变化 > 5 公斤（11 磅）。
  • 有甲状腺髓样癌 (MTC) 或多发性内分泌腺瘤 (MEN)2 综合征的家族史（一级亲属）或个人史。
  • 有慢性或急性胰腺炎病史。

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally once daily (QD), for a period of 72 weeks.
药品：安慰剂
口服给药。
实验性的：6 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 milligrams (mg) and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
药品：奥福列普隆
口服给药。
其他名称：
  • LY3502970
实验性的：12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
药品：奥福列普隆
口服给药。
其他名称：
  • LY3502970
实验性的：36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
药品：奥福列普隆
口服给药。
其他名称：
  • LY3502970

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Percent Change From Baseline in Body Weight (Primary Treatment Period)
大体时间：Baseline, Week 72
Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72

次要结果测量

结果测量
措施说明
大体时间
Change From Baseline in Waist Circumference (Primary Treatment Period)
大体时间：Baseline, Week 72
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
大体时间：Baseline, Week 72
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
大体时间：Baseline, Week 72
Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
大体时间：Baseline, Week 72
Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in HbA1c (Primary Treatment Period)
大体时间：Baseline, Week 72
  • Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time.
  • Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Fasting Serum Glucose (FSG) (Primary Treatment Period)
大体时间：Baseline, Week 72
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Percent Change From Baseline in Fasting Insulin (Primary Treatment Period)
大体时间：Baseline, Week 72
  • Fasting insulin is a blood test that measures the level of insulin in the blood after fasting.
  • Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
大体时间：Baseline, Week 72
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical Component and Mental Component) Scores - (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
大体时间：Baseline, Week 72
The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.
Baseline, Week 72
Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)
大体时间：Baseline, Week 176
Baseline, Week 176
Time to Onset of Type 2 Diabetes (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)
大体时间：Baseline through Week 176, Baseline through Week 190
Baseline through Week 176, Baseline through Week 190

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Eli Lilly and Company

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  • 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

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研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2023年6月5日

初级完成 (实际的)

2025年7月25日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2023年5月12日

首先提交符合 QC 标准的

2023年5月12日

首次发布 (实际的)

2023年5月22日

研究记录更新

最后更新发布 (实际的)

2026年8月14日

上次提交的符合 QC 标准的更新

2026年7月23日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 18559
  • J2A-MC-GZGP (其他标识符：Eli Lilly and Company)
  • 2022-502839-19-00 (其他标识符：Eli Lilly and Company)
  • U1111-1289-8877 (其他标识符：UTN Number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

在批准研究计划和签署数据共享协议后，将在安全访问环境中提供匿名的个人患者级别数据。

IPD 共享时间框架

ata 可在美国和欧盟 (EU) 研究的适应症首次公布和批准后 6 个月获得，以较晚者为准。 数据将无限期地可供请求。

IPD 共享访问标准

研究提案必须得到独立审查小组的批准，研究人员必须签署数据共享协议。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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