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En studie av Orforglipron hos voksne deltakere med fedme eller overvekt og type 2 diabetes (ATTAIN-2)

3. september 2026 oppdatert av: Eli Lilly and Company

En fase 3, randomisert, dobbeltblind studie for å undersøke effektiviteten og sikkerheten til oral LY3502970 én gang daglig sammenlignet med placebo hos voksne deltakere med fedme eller overvekt og type 2-diabetes (ATTAIN-2)

Denne studien vil undersøke sikkerheten og effekten av oral behandling én gang daglig med orforglipron sammenlignet med placebo på kroppsvekt hos voksne deltakere med fedme eller overvekt og type 2 diabetes. Studien vil vare i omtrent 77 uker og kan omfatte opptil 22 besøk.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1613

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • 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
  • Forente stater
    • Alabama
      • Pelham, Alabama, Forente stater, 35124
        • Cahaba Research - Pelham
    • Arizona
      • Tucson, Arizona, Forente stater, 85741
        • Novak Clinical Research - Tucson - North La Cholla Boulevard
      • Yuma, Arizona, Forente stater, 85364
        • Yuma Clinical Trials
    • California
      • Escondido, California, Forente stater, 92025
        • AMCR Institute
      • Huntington Park, California, Forente stater, 90255
        • Velocity Clinical Research, Huntington Park
      • Los Angeles, California, Forente stater, 90057
        • Velocity Clinical Research, Westlake
      • Montclair, California, Forente stater, 91763
        • Catalina Research Institute, LLC
      • Tustin, California, Forente stater, 92780
        • University Clinical Investigators, Inc.
    • Florida
      • Hollywood, Florida, Forente stater, 33024
        • Encore Medical Research
      • Jacksonville, Florida, Forente stater, 32216
        • East Coast Institute for Research, LLC
      • Margate, Florida, Forente stater, 33063
        • South Florida Clinical Research Institute
      • New Port Richey, Florida, Forente stater, 34652
        • Suncoast Clinical Research, Inc.
    • Georgia
      • Lawrenceville, Georgia, Forente stater, 30046
        • Balanced Life Health Care Solutions/SKYCRNG
      • Roswell, Georgia, Forente stater, 30076
        • Endocrine Research Solutions, Inc.
      • Woodstock, Georgia, Forente stater, 30189
        • North Georgia Clinical Research
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96813
        • Pacific Diabetes & Endocrine Center
    • Idaho
      • Meridian, Idaho, Forente stater, 83646
        • Solaris Clinical Research
    • Iowa
      • West Des Moines, Iowa, Forente stater, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Maryland
      • Baltimore, Maryland, Forente stater, 21239
        • MedStar Good Samaritan Hospital
    • Michigan
      • Troy, Michigan, Forente stater, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Missouri
      • City of Saint Peters, Missouri, Forente stater, 63303
        • StudyMetrix Research
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89128
        • Las Vegas Medical Research
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87109
        • IMA Clinical Research
    • New York
      • Albany, New York, Forente stater, 12203
        • Albany Medical College, Division of Community Endocrinology
      • Albany, New York, Forente stater, 12208
        • Albany Stratton VA Medical Center
      • Long Island City, New York, Forente stater, 11106
        • NYC Research INC
    • North Carolina
      • Raleigh, North Carolina, Forente stater, 27609
        • Accellacare - Raleigh
    • Oregon
      • Portland, Oregon, Forente stater, 97210
        • Summit Headlands
    • Tennessee
      • Knoxville, Tennessee, Forente stater, 37909
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Dallas, Texas, Forente stater, 75230
        • Velocity Clinical Research, Dallas
      • DeSoto, Texas, Forente stater, 75115
        • Epic Medical Research - DeSoto
      • Denison, Texas, Forente stater, 75020
        • Soma Clinical Trials
      • Houston, Texas, Forente stater, 77043
        • Biopharma Informatic, LLC
      • San Antonio, Texas, Forente stater, 78230
        • VIP Trials
      • San Antonio, Texas, Forente stater, 78229
        • Diabetes and Glandular Disease Center
    • Virginia
      • Charlottesville, Virginia, Forente stater, 22911
        • Charlottesville Medical Research
    • Washington
      • Tacoma, Washington, Forente stater, 98405
        • Universal Research Group
  • Hellas
      • Thessaloniki, Hellas, 564 29
        • 424 Military General Training Hospital
    • Attikí
      • Athens, Attikí, Hellas, 151 25
        • Athens Medical Center
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Hellas, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Hellas, 570 01
        • Thermi Clinic
      • Thessaloniki, Thessaloníki, Hellas, 546 45
        • Euromedica General Clinic of Thessaloniki
      • Thessaloniki, Thessaloníki, Hellas, 564 29
        • Papageorgiou General Hospital of Thessaloniki
    • Thessalía
      • Larissa, Thessalía, Hellas, 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
  • Kina
    • Anhui
      • Hefei, Anhui, Kina, 230011
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100853
        • Chinese PLA General Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400014
        • Chongqing General Hospital
    • Guangdong
      • Shenzhen, Guangdong, Kina, 518020
        • Shenzhen People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, Kina, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Luoyang Shi, Henan, Kina, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou, Henan, Kina, 450014
        • The Second Affiliated Hospital of Zhengzhou University
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, Kina, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, Kina, 210008
        • Jiangsu Province Official Hospital
      • Nantong, Jiangsu, Kina, 226001
        • Nantong First People's Hospital
      • Wuxi, Jiangsu, Kina, 214023
        • Wuxi People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330006
        • Jiangxi Provincial People's Hospital
    • Liaoning
      • Dalian, Liaoning, Kina, 116033
        • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
    • Shandong
      • Jinan, Shandong, Kina, 250013
        • Jinan Central Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, Kina, 300052
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin Municipality, Kina
        • Tianjin Medical University Zhu Xianyi Memorial Hospital
    • Yunnan
      • Kunming, Yunnan, Kina, 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
  • Sør -Korea
    • Kang-won-do
      • Wŏnju, Kang-won-do, Sør -Korea, 26426
        • Yonsei University-Wonju Severance Christian Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Sør -Korea, 13620
        • Seoul National University Bundang Hospital
    • Kyǒngsangbuk-do
      • Gyeongsan-si, Kyǒngsangbuk-do, Sør -Korea, 42415
        • Yeungnam Univeristy Medical Center
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Sør -Korea, 02841
        • Korea University Anam Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Sør -Korea, 06591
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Sør -Korea, 134-090
        • Kyung Hee University Hospital at Gangdong
  • Tsjekkia
      • Hradec Králové, Tsjekkia, 500 12
        • Endokrinologie MUDr. Rehorkova s.r.o.
      • Pilsen, Tsjekkia, 326 00
        • MUDr. Jitka Zemanová - diabetologie a interna s.r.o.
      • Český Krumlov, Tsjekkia, 381 01
        • Nemocnice Cesky Krumlov
    • Central Bohemia
      • Příbram, Central Bohemia, Tsjekkia, 26201
        • Milan Kvapil s.r.o., Diabetologicka ambulance Pribram
    • Moravskosl
      • Krnov, Moravskosl, Tsjekkia, 79401
        • MUDr. Tomas Edelsberger
    • Pardubice
      • Pardubice V, Pardubice, Tsjekkia, 530 02
        • Diahelp s.r.o
    • Plzeň-město
      • Pilsen, Plzeň-město, Tsjekkia, 301 00
        • Dialine - Interni a diabetologicka ambulance
    • Praha 1
      • Prague, Praha 1, Tsjekkia, 11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
    • Praha 4
      • Prague, Praha 4, Tsjekkia, 14900
        • Milan Kvapil s.r.o., Diabetologicka ambulance
    • Praha 8
      • Prague, Praha 8, Tsjekkia, 18100
        • ResTrial s.r.o.
    • Praha-západ
      • Jílové u Prahy, Praha-západ, Tsjekkia, 252 42
        • MUDr. Sabina Palova
    • South Bohemian Region
      • České Budějovice, South Bohemian Region, Tsjekkia, 37011
        • MUDr. Alena Váchová
  • Tyskland
      • Gelnhausen, Tyskland, 63571
        • Diabetes Zentrum Dr. Tews
      • Hamburg, Tyskland, 21109
        • Diabetes Zentrum Wilhelmsburg
    • Bavaria
      • München, Bavaria, Tyskland, 80809
        • CDG Studienambulanz Hartard
      • Wallerfing, Bavaria, Tyskland, 94574
        • Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
    • Hesse
      • Pohlheim, Hesse, Tyskland, 35415
        • Ceda-Research
    • Nordrhein-
      • Münster, Nordrhein-, Tyskland, 48145
        • Institut für Diabetesforschung GmbH Münster
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Tyskland, 50937
        • Universitaetsklinikum Koeln
      • Essen, North Rhine-Westphalia, Tyskland, 45355
        • Medizentrum Essen Borbeck
      • Essen, North Rhine-Westphalia, Tyskland, 45136
        • InnoDiab Forschung GmbH
    • Saxony
      • Leipzig, Saxony, Tyskland, 04107
        • AmBeNet GmbH
      • Pirna, Saxony, Tyskland, 01796
        • Arztpraxis Christine Kosch Pirna
    • Saxony-Anhalt
      • Hohenmölsen, Saxony-Anhalt, Tyskland, 06679
        • Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
      • Magdeburg, Saxony-Anhalt, Tyskland, 39120
        • SMO.MD GmbH
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Tyskland, 23562
        • Universität zu Lübeck - Institut für Endokrinologie und Diabetes
      • Oldenburg in Holstein, Schleswig-Holstein, Tyskland, 23758
        • Red-Institut GmbH

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Ha en kroppsmasseindeks (BMI) ≥27,0 kilogram/kvadratmeter (kg/m²).
  • Har en historie med minst 1 selvrapportert mislykket kostholdsforsøk for å gå ned i kroppsvekt.

  • Har diagnosen type 2 diabetes (T2D), med HbA1c ≥7 % (≥53 mmol/mol) til ≤10 % (86 mmol/mol) og er på stabil behandling for T2D i minst 90 dager før screening, bestående av av:

    • enten kosthold/trening alene eller
    • opptil 3 orale antihyperglykemiske medisiner (unntatt dipeptidylpeptidase IV-hemmere (DPP-4i) eller glukagonlignende peptid-1 (GLP-1) reseptoragonister (RA).

Ekskluderingskriterier:

  • Har type 1 diabetes (T1D), historie med ketoacidose eller hyperosmolar tilstand/koma, eller andre typer diabetes unntatt T2D.
  • Ha en selvrapportert endring i kroppsvekt >5 kg (11 pund) innen 90 dager før screening.
  • Mottar eller planlegger å motta behandling for diabetisk retinopati og/eller makulaødem (for eksempel laster fotokoagulasjon eller intravitreale injeksjoner av antivaskulære endotelial vekstfaktorhemmere).
  • Har familie (førstegradsslektning) eller personlig historie med medullær skjoldbruskkjertelkreft (MTC) eller multippel endokrin neoplasi 2 (MEN2) syndrom.
  • Har hatt en historie med kronisk eller akutt pankreatitt.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: 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.
Legemiddel: Placebo
Administreres oralt
Eksperimentell: 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.
Legemiddel: Orforglipron
Administrert oralt
Andre navn:
  • LY3502970
Eksperimentell: 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.
Legemiddel: Orforglipron
Administrert oralt
Andre navn:
  • LY3502970
Eksperimentell: 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.
Legemiddel: Orforglipron
Administrert oralt
Andre navn:
  • LY3502970

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percent Change From Baseline in Body Weight
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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) %
Tidsramme: 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)
Tidsramme: 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%)
Tidsramme: 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%)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Eli Lilly and Company

Etterforskere

  • Studieleder: 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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2023

Primær fullføring (Faktiske)

8. august 2025

Studiet fullført (Faktiske)

8. august 2025

Datoer for studieregistrering

Først innsendt

15. mai 2023

Først innsendt som oppfylte QC-kriteriene

15. mai 2023

Først lagt ut (Faktiske)

24. mai 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

4. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserte individuelle pasientnivådata vil bli gitt i et sikkert tilgangsmiljø ved godkjenning av et forskningsforslag og en signert datadelingsavtale.

IPD-delingstidsramme

Tidsramme:

Data er tilgjengelig 6 måneder etter den primære publisering og godkjenning av indikasjonen studert i USA og EU (EU), avhengig av hva som er senere. Data vil være tilgjengelig på ubestemt tid for forespørsel.

Tilgangskriterier for IPD-deling

Et forskningsforslag må godkjennes av et uavhengig granskningspanel og forskere må signere en datadelingsavtale.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere