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Une étude sur l'orforglipron chez des participants adultes souffrant d'obésité ou de surpoids et de diabète de type 2 (ATTAIN-2)

3 septembre 2026 mis à jour par: Eli Lilly and Company

Une étude de phase 3, randomisée, en double aveugle pour étudier l'efficacité et l'innocuité du LY3502970 par voie orale une fois par jour par rapport à un placebo chez des participants adultes souffrant d'obésité ou de surpoids et de diabète de type 2 (ATTAIN-2)

Cette étude examinera l'innocuité et l'efficacité d'un traitement oral une fois par jour par orforglipron par rapport à un placebo sur le poids corporel chez des participants adultes souffrant d'obésité ou de surpoids et de diabète de type 2. L'étude durera environ 77 semaines et pourra inclure jusqu'à 22 visites.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

1613

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

Critère d'intégration:

  • Avoir un indice de masse corporelle (IMC) ≥27,0 kilogramme/mètre carré (kg/m²).
  • Avoir une histoire d'au moins 1 effort diététique infructueux autodéclaré pour perdre du poids corporel.

  • Avoir un diagnostic de diabète de type 2 (DT2), avec HbA1c ≥7 % (≥53 mmol/mol) à ≤10 % (86 mmol/mol) et suivre un traitement stable pour le DT2 pendant au moins 90 jours avant le dépistage, consistant de:

    • soit régime/exercice seul ou
    • jusqu'à 3 médicaments antihyperglycémiants oraux (à l'exception des inhibiteurs de la dipeptidyl peptidase IV (DPP-4i) ou des agonistes des récepteurs (RA) du peptide-1 analogue au glucagon (GLP-1).

Critère d'exclusion:

  • Avoir un diabète de type 1 (DT1), des antécédents d'acidocétose ou d'état/coma hyperosmolaire, ou tout autre type de diabète à l'exception du DT2.
  • Avoir un changement autodéclaré de poids corporel> 5 kg (11 livres) dans les 90 jours précédant le dépistage.
  • Recevez actuellement ou prévoyez de recevoir un traitement pour la rétinopathie diabétique et/ou l'œdème maculaire (par exemple, photocoagulation au laser ou injections intravitréennes d'inhibiteurs du facteur de croissance de l'endothélium vasculaire).
  • Avoir des antécédents familiaux (parent au premier degré) ou personnels de cancer médullaire de la thyroïde (MTC) ou de syndrome de néoplasie endocrinienne multiple 2 (NEM2).
  • Avoir eu des antécédents de pancréatite chronique ou aiguë.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur 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.
Médicament: Placebo
Administré par voie orale
Expérimental: 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.
Médicament: Orforglipron
Administré par voie orale
Autres noms:
  • LY3502970
Expérimental: 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.
Médicament: Orforglipron
Administré par voie orale
Autres noms:
  • LY3502970
Expérimental: 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.
Médicament: Orforglipron
Administré par voie orale
Autres noms:
  • LY3502970

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percent Change From Baseline in Body Weight
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
Délai: 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
Délai: 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
Délai: 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
Délai: 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) %
Délai: 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)
Délai: 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%)
Délai: 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%)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Eli Lilly and Company

Les enquêteurs

  • Directeur d'études: 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

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

5 juin 2023

Achèvement primaire (Réel)

8 août 2025

Achèvement de l'étude (Réel)

8 août 2025

Dates d'inscription aux études

Première soumission

15 mai 2023

Première soumission répondant aux critères de contrôle qualité

15 mai 2023

Première publication (Réel)

24 mai 2023

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 septembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 septembre 2026

Dernière vérification

1 septembre 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

Les données anonymisées au niveau des patients individuels seront fournies dans un environnement d'accès sécurisé dès l'approbation d'une proposition de recherche et d'un accord de partage de données signé.

Délai de partage IPD

Délai:

Les données sont disponibles 6 mois après la publication primaire et l'approbation de l'indication étudiée aux États-Unis et dans l'Union européenne (UE), selon la date la plus tardive. Les données seront indéfiniment disponibles pour la demande.

Critères d'accès au partage IPD

Une proposition de recherche doit être approuvée par un comité d'examen indépendant et les chercheurs doivent signer un accord de partage de données.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • RSE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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