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Um estudo de orforglipron em participantes adultos com obesidade ou sobrepeso e diabetes tipo 2 (ATTAIN-2)

3 de setembro de 2026 atualizado por: Eli Lilly and Company

Um estudo duplo-cego randomizado de fase 3 para investigar a eficácia e a segurança do LY3502970 oral uma vez ao dia em comparação com o placebo em participantes adultos com obesidade ou sobrepeso e diabetes tipo 2 (ATTAIN-2)

Este estudo investigará a segurança e a eficácia do tratamento oral uma vez ao dia com orforglipron em comparação com placebo no peso corporal em participantes adultos com obesidade ou sobrepeso e diabetes tipo 2. O estudo durará cerca de 77 semanas e pode incluir até 22 visitas.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

1613

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

Critério de inclusão:

  • Ter um índice de massa corporal (IMC) ≥27,0 quilograma/metro quadrado (kg/m²).
  • Ter uma história de pelo menos 1 esforço dietético sem sucesso auto-relatado para perder peso corporal.

  • Ter diagnóstico de diabetes tipo 2 (DM2), com HbA1c ≥7% (≥53 mmol/mol) a ≤10% (86 mmol/mol) e estar em tratamento estável para DM2 por pelo menos 90 dias antes da triagem, consistindo de:

    • dieta/exercícios sozinhos ou
    • até 3 medicamentos anti-hiperglicêmicos orais (excluindo inibidores da dipeptidil peptidase IV (DPP-4i) ou agonistas do receptor (RA) do peptídeo-1 semelhante ao glucagon (GLP-1).

Critério de exclusão:

  • Tem diabetes tipo 1 (T1D), história de cetoacidose ou estado hiperosmolar/coma, ou qualquer outro tipo de diabetes, exceto DM2.
  • Ter uma alteração auto-relatada no peso corporal > 5 kg (11 libras) dentro de 90 dias antes da triagem.
  • Estão atualmente recebendo ou planejando receber tratamento para retinopatia diabética e/ou edema macular (por exemplo, fotocoagulação tardia ou injeções intravítreas de inibidores do fator de crescimento endotelial antivascular).
  • Ter história familiar (parente de primeiro grau) ou pessoal de câncer medular de tireoide (CMT) ou síndrome de neoplasia endócrina múltipla 2 (MEN2).
  • Tiveram história de pancreatite crônica ou aguda.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: 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.
Medicamento: Placebo
Administrado por via oral
Experimental: 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.
Medicamento: Orforglipron
Administrado por via oral
Outros nomes:
  • LY3502970
Experimental: 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.
Medicamento: Orforglipron
Administrado por via oral
Outros nomes:
  • LY3502970
Experimental: 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.
Medicamento: Orforglipron
Administrado por via oral
Outros nomes:
  • LY3502970

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percent Change From Baseline in Body Weight
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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) %
Prazo: 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)
Prazo: 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%)
Prazo: 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%)
Prazo: 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)
Prazo: 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)
Prazo: 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
Prazo: 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)
Prazo: 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)
Prazo: 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)
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Eli Lilly and Company

Investigadores

  • Diretor de estudo: 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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

5 de junho de 2023

Conclusão Primária (Real)

8 de agosto de 2025

Conclusão do estudo (Real)

8 de agosto de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

15 de maio de 2023

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de maio de 2023

Primeira postagem (Real)

24 de maio de 2023

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Os dados anônimos individuais do nível do paciente serão fornecidos em um ambiente de acesso seguro após a aprovação de uma proposta de pesquisa e um acordo de compartilhamento de dados assinado.

Prazo de Compartilhamento de IPD

Prazo:

Os dados estão disponíveis 6 meses após a publicação primária e aprovação da indicação estudada nos EUA e na União Europeia (UE), o que ocorrer mais tarde. Os dados ficarão indefinidamente disponíveis para solicitação.

Critérios de acesso de compartilhamento IPD

Uma proposta de pesquisa deve ser aprovada por um painel de revisão independente e os pesquisadores devem assinar um acordo de compartilhamento de dados.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CSR

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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