Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

Un estudio de orforglipron (LY3502970) en participantes adultos con obesidad o sobrepeso con comorbilidades relacionadas con el peso (ATTAIN-1)

23 de julio 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 con comorbilidades relacionadas con el peso (ATTAIN-1)

Este estudio investigará la eficacia y seguridad de orforglipron oral una vez al día en participantes adultos con obesidad o sobrepeso con comorbilidades relacionadas con el peso.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

3127

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

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

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 IMC

    • ≥30,0 kilogramo/metro cuadrado (kg/m²),

    • ≥27,0 kg/m² y presencia de al menos 1 de las siguientes comorbilidades relacionadas con el peso (tratadas o no tratadas) en la selección:

      • Hipertensión, dislipidemia, apnea obstructiva del sueño, enfermedad cardiovascular (por ejemplo, enfermedad cardiovascular isquémica, insuficiencia cardíaca de clase funcional I-III de la New York Heart Association).
  • Tener un historial de al menos 1 esfuerzo dietético fallido autoinformado para perder peso corporal.

Criterio de exclusión:

  • Tiene diabetes tipo 1, diabetes tipo 2 o cualquier otro tipo de diabetes, antecedentes de cetoacidosis o estado/coma hiperosmolar
  • Tener un cambio autoinformado en el peso corporal >5 kg (11 libras) dentro de los 90 días previos a la evaluación.
  • Tiene antecedentes familiares (familiares de primer grado) o personales de cáncer medular de tiroides (MTC) o síndrome de neoplasia endocrina múltiple (MEN)2.
  • 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
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally once daily (QD), for a period of 72 weeks.
Droga: Placebo
Administrado por vía oral.
Experimental: 6 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 milligrams (mg) and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
Droga: Orforglipron
Administrado por vía oral.
Otros nombres:
  • LY3502970
Experimental: 12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
Droga: Orforglipron
Administrado por vía oral.
Otros nombres:
  • LY3502970
Experimental: 36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
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 (Primary Treatment Period)
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 geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72

Medidas de resultado secundarias

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

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 8 AM - 8 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)

25 de julio de 2025

Finalización del estudio (Estimado)

1 de octubre de 2027

Fechas de registro del estudio

Enviado por primera vez

12 de mayo de 2023

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2023

Publicado por primera vez (Actual)

22 de mayo de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2026

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

23 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 18559
  • J2A-MC-GZGP (Otro identificador: Eli Lilly and Company)
  • 2022-502839-19-00 (Otro identificador: Eli Lilly and Company)
  • U1111-1289-8877 (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

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. .

Suscribir