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Un estudio de orforglipron en participantes adultos con obesidad o sobrepeso y diabetes tipo 2 (ATTAIN-2)

3 de septiembre de 2026 actualizado por: Eli Lilly and Company

Un estudio de fase 3, aleatorizado, doble ciego para investigar la eficacia y seguridad de LY3502970 oral una vez al día en comparación con placebo en participantes adultos con obesidad o sobrepeso y diabetes tipo 2 (ATTAIN-2)

Este estudio investigará la seguridad y la eficacia del tratamiento oral una vez al día con orforglipron en comparación con el placebo sobre el peso corporal en participantes adultos con obesidad o sobrepeso y diabetes tipo 2. El estudio durará alrededor de 77 semanas y puede incluir hasta 22 visitas.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

1613

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Gelnhausen, Alemania, 63571
        • Diabetes Zentrum Dr. Tews
      • Hamburg, Alemania, 21109
        • Diabetes Zentrum Wilhelmsburg
    • Bavaria
      • München, Bavaria, Alemania, 80809
        • CDG Studienambulanz Hartard
      • Wallerfing, Bavaria, Alemania, 94574
        • Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
    • Hesse
      • Pohlheim, Hesse, Alemania, 35415
        • Ceda-Research
    • Nordrhein-
      • Münster, Nordrhein-, Alemania, 48145
        • Institut für Diabetesforschung GmbH Münster
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Alemania, 50937
        • Universitaetsklinikum Koeln
      • Essen, North Rhine-Westphalia, Alemania, 45355
        • Medizentrum Essen Borbeck
      • Essen, North Rhine-Westphalia, Alemania, 45136
        • InnoDiab Forschung GmbH
    • Saxony
      • Leipzig, Saxony, Alemania, 04107
        • AmBeNet GmbH
      • Pirna, Saxony, Alemania, 01796
        • Arztpraxis Christine Kosch Pirna
    • Saxony-Anhalt
      • Hohenmölsen, Saxony-Anhalt, Alemania, 06679
        • Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
      • Magdeburg, Saxony-Anhalt, Alemania, 39120
        • SMO.MD GmbH
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Alemania, 23562
        • Universität zu Lübeck - Institut für Endokrinologie und Diabetes
      • Oldenburg in Holstein, Schleswig-Holstein, Alemania, 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
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research
      • Merewether, New South Wales, Australia, 2291
        • The AIM Centre / Hunter Diabetes Centre
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Brisbane, Queensland, Australia, 4064
        • Core Research Group
      • Meadowbrook, Queensland, Australia, 4131
        • Logan Hospital
    • South Australia
      • Oaklands Park, South Australia, Australia, 5046
        • Southern Adelaide Diabetes & Endocrine services
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
      • Heidelberg West, Victoria, Australia, 3081
        • Austin Health - Repatriation Hospital
      • Melbourne, Victoria, Australia, 3004
        • Baker IDI Heart and Diabetes Institute - Melbourne
    • Western Australia
      • Joondalup, Western Australia, Australia, 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
  • Chequia
      • Hradec Králové, Chequia, 500 12
        • Endokrinologie MUDr. Rehorkova s.r.o.
      • Pilsen, Chequia, 326 00
        • MUDr. Jitka Zemanová - diabetologie a interna s.r.o.
      • Český Krumlov, Chequia, 381 01
        • Nemocnice Cesky Krumlov
    • Central Bohemia
      • Příbram, Central Bohemia, Chequia, 26201
        • Milan Kvapil s.r.o., Diabetologicka ambulance Pribram
    • Moravskosl
      • Krnov, Moravskosl, Chequia, 79401
        • MUDr. Tomas Edelsberger
    • Pardubice
      • Pardubice V, Pardubice, Chequia, 530 02
        • Diahelp s.r.o
    • Plzeň-město
      • Pilsen, Plzeň-město, Chequia, 301 00
        • Dialine - Interni a diabetologicka ambulance
    • Praha 1
      • Prague, Praha 1, Chequia, 11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
    • Praha 4
      • Prague, Praha 4, Chequia, 14900
        • Milan Kvapil s.r.o., Diabetologicka ambulance
    • Praha 8
      • Prague, Praha 8, Chequia, 18100
        • ResTrial s.r.o.
    • Praha-západ
      • Jílové u Prahy, Praha-západ, Chequia, 252 42
        • MUDr. Sabina Palova
    • South Bohemian Region
      • České Budějovice, South Bohemian Region, Chequia, 37011
        • MUDr. Alena Váchová
  • Corea del Sur
    • Kang-won-do
      • Wŏnju, Kang-won-do, Corea del Sur, 26426
        • Yonsei University-Wonju Severance Christian Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Corea del Sur, 13620
        • Seoul National University Bundang Hospital
    • Kyǒngsangbuk-do
      • Gyeongsan-si, Kyǒngsangbuk-do, Corea del Sur, 42415
        • Yeungnam Univeristy Medical Center
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 02841
        • Korea University Anam Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 06591
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 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
  • Grecia
      • Thessaloniki, Grecia, 564 29
        • 424 Military General Training Hospital
    • Attikí
      • Athens, Attikí, Grecia, 151 25
        • Athens Medical Center
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Grecia, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Grecia, 570 01
        • Thermi Clinic
      • Thessaloniki, Thessaloníki, Grecia, 546 45
        • Euromedica General Clinic of Thessaloniki
      • Thessaloniki, Thessaloníki, Grecia, 564 29
        • Papageorgiou General Hospital of Thessaloniki
    • Thessalía
      • Larissa, Thessalía, Grecia, 41110
        • University General Hospital of Larissa
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Medstar Speciality Hospital
      • Hubli, Karnataka, India, 580021
        • Karnataka Institute of Medical Sciences
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
      • Mumbai, Maharashtra, India, 400058
        • BSES MG Hospital
      • Nagpur, Maharashtra, India, 441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
      • Pune, Maharashtra, India, 411004
        • Sahyadri Super Speciality Hospital
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • Arthur Asirvatham Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Kumudini Devi Diabetes Research Center
  • Porcelana
    • Anhui
      • Hefei, Anhui, Porcelana, 230011
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100853
        • Chinese PLA General Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Porcelana, 400014
        • Chongqing General Hospital
    • Guangdong
      • Shenzhen, Guangdong, Porcelana, 518020
        • Shenzhen People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, Porcelana, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Luoyang Shi, Henan, Porcelana, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou, Henan, Porcelana, 450014
        • The Second Affiliated Hospital of Zhengzhou University
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, Porcelana, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, Porcelana, 210008
        • Jiangsu Province Official Hospital
      • Nantong, Jiangsu, Porcelana, 226001
        • Nantong First People's Hospital
      • Wuxi, Jiangsu, Porcelana, 214023
        • Wuxi People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, Porcelana, 330006
        • Jiangxi Provincial People's Hospital
    • Liaoning
      • Dalian, Liaoning, Porcelana, 116033
        • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
    • Shandong
      • Jinan, Shandong, Porcelana, 250013
        • Jinan Central Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Porcelana, 300052
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin Municipality, Porcelana
        • Tianjin Medical University Zhu Xianyi Memorial Hospital
    • Yunnan
      • Kunming, Yunnan, Porcelana, 650034
        • The First People's Hospital of Yunnan Province
  • Puerto Rico
    • PR
      • Bayamón, PR, Puerto Rico, 00959
        • Advanced Clinical Research, LLC
      • Guaynabo, PR, Puerto Rico, 00968
        • Isis Clinical Research Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Tener un índice de masa corporal (IMC) ≥27,0 kilogramo/metro cuadrado (kg/m²).
  • Tener un historial de al menos 1 esfuerzo dietético fallido autoinformado para perder peso corporal.

  • Tener un diagnóstico de diabetes tipo 2 (T2D), con HbA1c ≥7 % (≥53 mmol/mol) a ≤10 % (86 mmol/mol) y estar en tratamiento estable para T2D durante al menos 90 días antes de la selección, que consiste en de:

    • ya sea dieta/ejercicio solo o
    • hasta 3 medicamentos antihiperglucémicos orales (excluyendo los inhibidores de la dipeptidil peptidasa IV (DPP-4i) o los agonistas del receptor (AR) del péptido-1 similar al glucagón (GLP-1).

Criterio de exclusión:

  • Tiene diabetes tipo 1 (T1D), antecedentes de cetoacidosis o estado/coma hiperosmolar, o cualquier otro tipo de diabetes excepto T2D.
  • Tener un cambio autoinformado en el peso corporal >5 kg (11 libras) dentro de los 90 días previos a la evaluación.
  • Actualmente recibe o planea recibir tratamiento para la retinopatía diabética y/o el edema macular (por ejemplo, fotocoagulación posterior o inyecciones intravítreas de inhibidores del factor de crecimiento endotelial antivascular).
  • Tiene antecedentes familiares (familiares de primer grado) o personales de cáncer medular de tiroides (MTC) o síndrome de neoplasia endocrina múltiple 2 (MEN2).
  • Haber tenido antecedentes de pancreatitis crónica o aguda.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: 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.
Droga: Placebo
Administrado por vía 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.
Droga: Orforglipron
Administrado por vía oral
Otros nombres:
  • 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.
Droga: Orforglipron
Administrado por vía oral
Otros nombres:
  • 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.
Droga: Orforglipron
Administrado por vía oral
Otros nombres:
  • LY3502970

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percent Change From Baseline in Body Weight
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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) %
Periodo de tiempo: 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)
Periodo de tiempo: 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%)
Periodo de tiempo: 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%)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Investigadores

  • Director de estudio: 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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de junio de 2023

Finalización primaria (Actual)

8 de agosto de 2025

Finalización del estudio (Actual)

8 de agosto de 2025

Fechas de registro del estudio

Enviado por primera vez

15 de mayo de 2023

Primero enviado que cumplió con los criterios de control de calidad

15 de mayo de 2023

Publicado por primera vez (Actual)

24 de mayo de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Los datos anónimos a nivel de paciente individual se proporcionarán en un entorno de acceso seguro tras la aprobación de una propuesta de investigación y un acuerdo de intercambio de datos firmado.

Marco de tiempo para compartir IPD

Periodo de tiempo:

Los datos están disponibles 6 meses después de la publicación principal y la aprobación de la indicación estudiada en los EE. UU. y la Unión Europea (UE), lo que ocurra más tarde. Los datos estarán indefinidamente disponibles para solicitarlos.

Criterios de acceso compartido de IPD

Una propuesta de investigación debe ser aprobada por un panel de revisión independiente y los investigadores deben firmar un acuerdo de intercambio de datos.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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