이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

비만 또는 과체중 및 제2형 당뇨병이 있는 성인 참가자의 Orforglipron에 대한 연구 (ATTAIN-2)

2026년 9월 3일 업데이트: Eli Lilly and Company

비만 또는 과체중 및 제2형 당뇨병(ATTAIN-2) 성인 참가자를 대상으로 위약과 비교하여 1일 1회 경구 LY3502970의 효능 및 안전성을 조사하기 위한 3상 무작위 이중 맹검 연구(ATTAIN-2)

이 연구는 비만 또는 과체중 및 제2형 당뇨병이 있는 성인 참가자의 체중에 대한 위약과 비교하여 오르포글립론을 1일 1회 경구 투여하는 안전성 및 효능을 조사할 것입니다. 연구는 약 77주 동안 지속되며 최대 22회의 방문이 포함될 수 있습니다.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

1613

단계

  • 3단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 그리스
      • Thessaloniki, 그리스, 564 29
        • 424 Military General Training Hospital
    • Attikí
      • Athens, Attikí, 그리스, 151 25
        • Athens Medical Center
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, 그리스, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Thessaloníki
      • Thessaloniki, Thessaloníki, 그리스, 570 01
        • Thermi Clinic
      • Thessaloniki, Thessaloníki, 그리스, 546 45
        • Euromedica General Clinic of Thessaloniki
      • Thessaloniki, Thessaloníki, 그리스, 564 29
        • Papageorgiou General Hospital of Thessaloniki
    • Thessalía
      • Larissa, Thessalía, 그리스, 41110
        • University General Hospital of Larissa
  • 대한민국
    • Kang-won-do
      • Wŏnju, Kang-won-do, 대한민국, 26426
        • Yonsei University-Wonju Severance Christian Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, 대한민국, 13620
        • Seoul National University Bundang Hospital
    • Kyǒngsangbuk-do
      • Gyeongsan-si, Kyǒngsangbuk-do, 대한민국, 42415
        • Yeungnam Univeristy Medical Center
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], 대한민국, 02841
        • Korea University Anam Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], 대한민국, 06591
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], 대한민국, 134-090
        • Kyung Hee University Hospital at Gangdong
  • 독일
      • Gelnhausen, 독일, 63571
        • Diabetes Zentrum Dr. Tews
      • Hamburg, 독일, 21109
        • Diabetes Zentrum Wilhelmsburg
    • Bavaria
      • München, Bavaria, 독일, 80809
        • CDG Studienambulanz Hartard
      • Wallerfing, Bavaria, 독일, 94574
        • Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
    • Hesse
      • Pohlheim, Hesse, 독일, 35415
        • Ceda-Research
    • Nordrhein-
      • Münster, Nordrhein-, 독일, 48145
        • Institut für Diabetesforschung GmbH Münster
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, 독일, 50937
        • Universitaetsklinikum Koeln
      • Essen, North Rhine-Westphalia, 독일, 45355
        • Medizentrum Essen Borbeck
      • Essen, North Rhine-Westphalia, 독일, 45136
        • InnoDiab Forschung GmbH
    • Saxony
      • Leipzig, Saxony, 독일, 04107
        • AmBeNet GmbH
      • Pirna, Saxony, 독일, 01796
        • Arztpraxis Christine Kosch Pirna
    • Saxony-Anhalt
      • Hohenmölsen, Saxony-Anhalt, 독일, 06679
        • Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
      • Magdeburg, Saxony-Anhalt, 독일, 39120
        • SMO.MD GmbH
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, 독일, 23562
        • Universität zu Lübeck - Institut für Endokrinologie und Diabetes
      • Oldenburg in Holstein, Schleswig-Holstein, 독일, 23758
        • Red-Institut GmbH
  • 미국
    • Alabama
      • Pelham, Alabama, 미국, 35124
        • Cahaba Research - Pelham
    • Arizona
      • Tucson, Arizona, 미국, 85741
        • Novak Clinical Research - Tucson - North La Cholla Boulevard
      • Yuma, Arizona, 미국, 85364
        • Yuma Clinical Trials
    • California
      • Escondido, California, 미국, 92025
        • AMCR Institute
      • Huntington Park, California, 미국, 90255
        • Velocity Clinical Research, Huntington Park
      • Los Angeles, California, 미국, 90057
        • Velocity Clinical Research, Westlake
      • Montclair, California, 미국, 91763
        • Catalina Research Institute, LLC
      • Tustin, California, 미국, 92780
        • University Clinical Investigators, Inc.
    • Florida
      • Hollywood, Florida, 미국, 33024
        • Encore Medical Research
      • Jacksonville, Florida, 미국, 32216
        • East Coast Institute for Research, LLC
      • Margate, Florida, 미국, 33063
        • South Florida Clinical Research Institute
      • New Port Richey, Florida, 미국, 34652
        • Suncoast Clinical Research, Inc.
    • Georgia
      • Lawrenceville, Georgia, 미국, 30046
        • Balanced Life Health Care Solutions/SKYCRNG
      • Roswell, Georgia, 미국, 30076
        • Endocrine Research Solutions, Inc.
      • Woodstock, Georgia, 미국, 30189
        • North Georgia Clinical Research
    • Hawaii
      • Honolulu, Hawaii, 미국, 96813
        • Pacific Diabetes & Endocrine Center
    • Idaho
      • Meridian, Idaho, 미국, 83646
        • Solaris Clinical Research
    • Iowa
      • West Des Moines, Iowa, 미국, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Maryland
      • Baltimore, Maryland, 미국, 21239
        • MedStar Good Samaritan Hospital
    • Michigan
      • Troy, Michigan, 미국, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Missouri
      • City of Saint Peters, Missouri, 미국, 63303
        • StudyMetrix Research
    • Nevada
      • Las Vegas, Nevada, 미국, 89128
        • Las Vegas Medical Research
    • New Mexico
      • Albuquerque, New Mexico, 미국, 87109
        • IMA Clinical Research
    • New York
      • Albany, New York, 미국, 12203
        • Albany Medical College, Division of Community Endocrinology
      • Albany, New York, 미국, 12208
        • Albany Stratton VA Medical Center
      • Long Island City, New York, 미국, 11106
        • NYC Research INC
    • North Carolina
      • Raleigh, North Carolina, 미국, 27609
        • Accellacare - Raleigh
    • Oregon
      • Portland, Oregon, 미국, 97210
        • Summit Headlands
    • Tennessee
      • Knoxville, Tennessee, 미국, 37909
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Dallas, Texas, 미국, 75230
        • Velocity Clinical Research, Dallas
      • DeSoto, Texas, 미국, 75115
        • Epic Medical Research - DeSoto
      • Denison, Texas, 미국, 75020
        • Soma Clinical Trials
      • Houston, Texas, 미국, 77043
        • Biopharma Informatic, LLC
      • San Antonio, Texas, 미국, 78230
        • VIP Trials
      • San Antonio, Texas, 미국, 78229
        • Diabetes and Glandular Disease Center
    • Virginia
      • Charlottesville, Virginia, 미국, 22911
        • Charlottesville Medical Research
    • Washington
      • Tacoma, Washington, 미국, 98405
        • Universal Research Group
  • 브라질
      • São Paulo, 브라질, 04266-010
        • CEPIC - Centro Paulista de Investigação Clínica
    • Federal District
      • Brasília, Federal District, 브라질, 71625-175
        • Centro de Pesquisa Clinica do Brasil
    • Goiás
      • Goiânia, Goiás, 브라질, 74230-035
        • Cendi - Endocrinologia e Diabetes
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, 브라질, 99010-120
        • Instituto Méderi de Pesquisa e Saúde
    • Rio de Janeiro
      • Volta Redonda, Rio de Janeiro, 브라질, 27253-003
        • Instituto Lóbus
    • São Paulo
      • Campinas, São Paulo, 브라질, 13060-080
        • Instituto de Pesquisa Clínica de Campinas
      • Marília, São Paulo, 브라질, 17504-072
        • Centro de Pesquisa Clínica de Marília - CPCLIM
      • Santo André, São Paulo, 브라질, 09080-110
        • Pesquisare Saúde
  • 아르헨티나
      • Buenos Aires, 아르헨티나, 1012
        • CONEXA Investigacion Clinica S.A.
      • Córdoba, 아르헨티나, 5000
        • Centro Diabetológico Dr. Waitman
      • Córdoba, 아르헨티나, X50004FHP
        • Clínica Universitaria Reina Fabiola
      • Santa Fe, 아르헨티나, 3000
        • Centro de Diagnóstico y Rehabilitación (CEDIR)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., 아르헨티나, C1128AAF
        • Mautalen Salud e investigación
    • Ciudad Aut
      • C.a.b.a., Ciudad Aut, 아르헨티나, C1205AAO
        • CEMEDIAB
    • Ciudad Autónoma de Buenos Aire
      • CABA, Ciudad Autónoma de Buenos Aire, 아르헨티나, 1204
        • Instituto Centenario
    • Santa Fe Province
      • Rosario, Santa Fe Province, 아르헨티나, 2000
        • Instituto de Investigaciones Clinicas Rosario
      • Rosario, Santa Fe Province, 아르헨티나, 2000
        • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
      • Venado Tuerto, Santa Fe Province, 아르헨티나, 2600
        • Sanatorio San Martin
    • Tucumán Province
      • SAN M. de Tucuman, Tucumán Province, 아르헨티나, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • 인도
    • Karnataka
      • Bangalore, Karnataka, 인도, 560092
        • Medstar Speciality Hospital
      • Hubli, Karnataka, 인도, 580021
        • Karnataka Institute of Medical Sciences
    • Madhya Pradesh
      • Indore, Madhya Pradesh, 인도, 452010
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Mumbai, Maharashtra, 인도, 400008
        • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
      • Mumbai, Maharashtra, 인도, 400058
        • BSES MG Hospital
      • Nagpur, Maharashtra, 인도, 441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
      • Pune, Maharashtra, 인도, 411004
        • Sahyadri Super Speciality Hospital
    • Tamil Nadu
      • Madurai, Tamil Nadu, 인도, 625020
        • Arthur Asirvatham Hospital
    • Telangana
      • Hyderabad, Telangana, 인도, 500082
        • Kumudini Devi Diabetes Research Center
  • 중국
    • Anhui
      • Hefei, Anhui, 중국, 230011
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국, 100853
        • Chinese PLA General Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, 중국, 400014
        • Chongqing General Hospital
    • Guangdong
      • Shenzhen, Guangdong, 중국, 518020
        • Shenzhen People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, 중국, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Luoyang Shi, Henan, 중국, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou, Henan, 중국, 450014
        • The Second Affiliated Hospital of Zhengzhou University
    • Jiangsu
      • Nanjing, Jiangsu, 중국, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, 중국, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, 중국, 210008
        • Jiangsu Province Official Hospital
      • Nantong, Jiangsu, 중국, 226001
        • Nantong First People's Hospital
      • Wuxi, Jiangsu, 중국, 214023
        • Wuxi People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, 중국, 330006
        • Jiangxi Provincial People's Hospital
    • Liaoning
      • Dalian, Liaoning, 중국, 116033
        • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
    • Shandong
      • Jinan, Shandong, 중국, 250013
        • Jinan Central Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, 중국, 300052
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin Municipality, 중국
        • Tianjin Medical University Zhu Xianyi Memorial Hospital
    • Yunnan
      • Kunming, Yunnan, 중국, 650034
        • The First People's Hospital of Yunnan Province
  • 체코
      • Hradec Králové, 체코, 500 12
        • Endokrinologie MUDr. Rehorkova s.r.o.
      • Pilsen, 체코, 326 00
        • MUDr. Jitka Zemanová - diabetologie a interna s.r.o.
      • Český Krumlov, 체코, 381 01
        • Nemocnice Cesky Krumlov
    • Central Bohemia
      • Příbram, Central Bohemia, 체코, 26201
        • Milan Kvapil s.r.o., Diabetologicka ambulance Pribram
    • Moravskosl
      • Krnov, Moravskosl, 체코, 79401
        • MUDr. Tomas Edelsberger
    • Pardubice
      • Pardubice V, Pardubice, 체코, 530 02
        • Diahelp s.r.o
    • Plzeň-město
      • Pilsen, Plzeň-město, 체코, 301 00
        • Dialine - Interni a diabetologicka ambulance
    • Praha 1
      • Prague, Praha 1, 체코, 11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
    • Praha 4
      • Prague, Praha 4, 체코, 14900
        • Milan Kvapil s.r.o., Diabetologicka ambulance
    • Praha 8
      • Prague, Praha 8, 체코, 18100
        • ResTrial s.r.o.
    • Praha-západ
      • Jílové u Prahy, Praha-západ, 체코, 252 42
        • MUDr. Sabina Palova
    • South Bohemian Region
      • České Budějovice, South Bohemian Region, 체코, 37011
        • MUDr. Alena Váchová
  • 푸에르토 리코
    • PR
      • Bayamón, PR, 푸에르토 리코, 00959
        • Advanced Clinical Research, LLC
      • Guaynabo, PR, 푸에르토 리코, 00968
        • Isis Clinical Research Center
  • 호주
    • New South Wales
      • Botany, New South Wales, 호주, 2019
        • Emeritus Research
      • Merewether, New South Wales, 호주, 2291
        • The AIM Centre / Hunter Diabetes Centre
    • Queensland
      • Brisbane, Queensland, 호주, 4029
        • Royal Brisbane and Women's Hospital
      • Brisbane, Queensland, 호주, 4064
        • Core Research Group
      • Meadowbrook, Queensland, 호주, 4131
        • Logan Hospital
    • South Australia
      • Oaklands Park, South Australia, 호주, 5046
        • Southern Adelaide Diabetes & Endocrine services
    • Victoria
      • Box Hill, Victoria, 호주, 3128
        • Box Hill Hospital
      • Camberwell, Victoria, 호주, 3124
        • Emeritus Research
      • Heidelberg West, Victoria, 호주, 3081
        • Austin Health - Repatriation Hospital
      • Melbourne, Victoria, 호주, 3004
        • Baker IDI Heart and Diabetes Institute - Melbourne
    • Western Australia
      • Joondalup, Western Australia, 호주, 6027
        • Advara HeartCare Joondalup

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

포함 기준:

  • 체질량 지수(BMI)가 27.0kg/제곱미터(kg/m²) 이상이어야 합니다.
  • 체중 감량을 위한 식이 요법에 실패한 자가 보고한 적이 1회 이상 있습니다.

  • HbA1c ≥7%(≥53mmol/mol) ~ ≤10%(86mmol/mol)인 제2형 당뇨병(T2D) 진단을 받고 스크리닝 전 최소 90일 동안 안정적인 제2형 당뇨병 치료를 받고 있으며 다음으로 구성됨 의:

    • 식이요법/운동을 혼자 하거나
    • 최대 3개의 경구 항고혈당제(디펩티딜 펩티다제 IV 억제제(DPP-4i) 또는 글루카곤 유사 펩티드-1(GLP-1) 수용체 작용제(RA) 제외).

제외 기준:

  • 제1형 당뇨병(T1D), 케톤산증 또는 고삼투압 상태/혼수 또는 제2형을 제외한 다른 유형의 당뇨병 병력이 있는 경우.
  • 스크리닝 전 90일 이내에 자가 보고한 체중 >5kg(11파운드)의 변화가 있어야 합니다.
  • 당뇨병성 망막병증 및/또는 황반 부종(예: 래스터 광응고술 또는 항혈관 내피 성장 인자 억제제의 유리체강내 주사)에 대한 치료를 현재 받고 있거나 받을 계획입니다.
  • 갑상선 수질암(MTC) 또는 다발성 내분비 종양 2(MEN2) 증후군의 가족(직계 가족) 또는 개인 병력이 있습니다.
  • 만성 또는 급성 췌장염의 병력이 있습니다.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Placebo
Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 milligram (mg) equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
의약품: 위약
구두로 관리
실험적: 6 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
의약품: 오르포글리프론
구두로 관리
다른 이름들:
  • LY3502970
실험적: 12 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
의약품: 오르포글리프론
구두로 관리
다른 이름들:
  • LY3502970
실험적: 36 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
의약품: 오르포글리프론
구두로 관리
다른 이름들:
  • LY3502970

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percent Change From Baseline in Body Weight
기간: 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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral antihyperglycemic medications (AHMs) classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
기간: Baseline to Week 72
Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Baseline to Week 72
Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline
기간: Baseline to Week 72
Percentage of participants with ≥10% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Baseline to Week 72
Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline
기간: Baseline to Week 72
Percentage of participants with ≥15% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Baseline to Week 72
Change From Baseline in Waist Circumference
기간: 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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Hemoglobin A1c (HbA1c) %
기간: 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 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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Fasting Serum Glucose (FSG)
기간: 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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<6.5%)
기간: Baseline to Week 72
Percentage of participants who achieved hemoglobin A1c (HbA1c<6.5%) was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Baseline to Week 72
Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<7.0%)
기간: Baseline to Week 72
Percentage of participants who achieved hemoglobin A1c (HbA1c<7%) was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Baseline to Week 72
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
기간: 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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). 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)
기간: 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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Percent Change From Baseline in Fasting Insulin
기간: Baseline, Week 72
  • Fasting Insulin is a test used to measure the amount of insulin in the body.
  • Values represented under "Geometric Least Squares Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure 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)
기간: Baseline, Week 72
Values represented under "Geometric Least Squares Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.
Baseline, Week 72
Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
기간: Baseline, Week 72
Values represented under "Geometric Least Square Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure 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)
기간: Baseline, Week 72
The SF-36v2 acute form, (1-week recall version) assesses participants' health-related quality of life on 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Eli Lilly and Company

수사관

  • 연구 책임자: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 6월 5일

기본 완료 (실제)

2025년 8월 8일

연구 완료 (실제)

2025년 8월 8일

연구 등록 날짜

최초 제출

2023년 5월 15일

QC 기준을 충족하는 최초 제출

2023년 5월 15일

처음 게시됨 (실제)

2023년 5월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 3일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 18560 (City of Hope Comprehensive Cancer Center)
  • J2A-MC-GZGQ (기타 식별자: Eli Lilly and Company)
  • 2022-502837-24-00 (기타 식별자: Eli Lilly and Company)
  • U1111-1289-8799 (기타 식별자: UTN Number)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

익명화된 개별 환자 수준 데이터는 연구 제안 및 서명된 데이터 공유 계약의 승인 시 안전한 액세스 환경에서 제공됩니다.

IPD 공유 기간

기간:

데이터는 미국과 유럽 연합(EU)에서 연구된 적응증의 1차 출판 및 승인 중 더 늦은 시점으로부터 6개월 후에 사용할 수 있습니다. 요청 시 데이터를 무기한 사용할 수 있습니다.

IPD 공유 액세스 기준

연구 제안은 독립적인 검토 패널의 승인을 받아야 하며 연구자는 데이터 공유 계약에 서명해야 합니다.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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