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En undersøgelse af Orforglipron hos voksne deltagere med fedme eller overvægt og type 2-diabetes (ATTAIN-2)

3. september 2026 opdateret af: Eli Lilly and Company

En fase 3, randomiseret, dobbeltblind undersøgelse for at undersøge effektiviteten og sikkerheden af ​​oral LY3502970 én gang dagligt sammenlignet med placebo hos voksne deltagere med fedme eller overvægt og type 2-diabetes (ATTAIN-2)

Denne undersøgelse vil undersøge sikkerheden og effekten af ​​oral behandling én gang dagligt med orforglipron sammenlignet med placebo på kropsvægt hos voksne deltagere med fedme eller overvægt og type 2-diabetes. Undersøgelsen vil vare omkring 77 uger og kan omfatte op til 22 besøg.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1613

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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 Medicas Tucuman
  • Australien
    • New South Wales
      • Botany, New South Wales, Australien, 2019
        • Emeritus Research
      • Merewether, New South Wales, Australien, 2291
        • The AIM Centre / Hunter Diabetes Centre
    • Queensland
      • Brisbane, Queensland, Australien, 4029
        • Royal Brisbane and Women's Hospital
      • Brisbane, Queensland, Australien, 4064
        • Core Research Group
      • Meadowbrook, Queensland, Australien, 4131
        • Logan Hospital
    • South Australia
      • Oaklands Park, South Australia, Australien, 5046
        • Southern Adelaide Diabetes & Endocrine Services
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Box Hill Hospital
      • Camberwell, Victoria, Australien, 3124
        • Emeritus Research
      • Heidelberg West, Victoria, Australien, 3081
        • Austin Health - Repatriation Hospital
      • Melbourne, Victoria, Australien, 3004
        • Baker IDI Heart and Diabetes Institute - Melbourne
    • Western Australia
      • Joondalup, Western Australia, Australien, 6027
        • Advara HeartCare Joondalup
  • Brasilien
      • São Paulo, Brasilien, 04266-010
        • CEPIC - Centro Paulista de Investigação Clínica
    • Federal District
      • Brasília, Federal District, Brasilien, 71625-175
        • Centro de Pesquisa Clinica do Brasil
    • Goiás
      • Goiânia, Goiás, Brasilien, 74230-035
        • Cendi - Endocrinologia e Diabetes
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brasilien, 99010-120
        • Instituto Méderi de Pesquisa e Saúde
    • Rio de Janeiro
      • Volta Redonda, Rio de Janeiro, Brasilien, 27253-003
        • Instituto Lóbus
    • São Paulo
      • Campinas, São Paulo, Brasilien, 13060-080
        • Instituto de Pesquisa Clínica de Campinas
      • Marília, São Paulo, Brasilien, 17504-072
        • Centro de Pesquisa Clínica de Marília - CPCLIM
      • Santo André, São Paulo, Brasilien, 09080-110
        • Pesquisare Saúde
  • Forenede Stater
    • Alabama
      • Pelham, Alabama, Forenede Stater, 35124
        • Cahaba Research - Pelham
    • Arizona
      • Tucson, Arizona, Forenede Stater, 85741
        • Novak Clinical Research - Tucson - North La Cholla Boulevard
      • Yuma, Arizona, Forenede Stater, 85364
        • Yuma Clinical Trials
    • California
      • Escondido, California, Forenede Stater, 92025
        • AMCR Institute
      • Huntington Park, California, Forenede Stater, 90255
        • Velocity Clinical Research, Huntington Park
      • Los Angeles, California, Forenede Stater, 90057
        • Velocity Clinical Research, Westlake
      • Montclair, California, Forenede Stater, 91763
        • Catalina Research Institute, LLC
      • Tustin, California, Forenede Stater, 92780
        • University Clinical Investigators, Inc.
    • Florida
      • Hollywood, Florida, Forenede Stater, 33024
        • Encore Medical Research
      • Jacksonville, Florida, Forenede Stater, 32216
        • East Coast Institute for Research, LLC
      • Margate, Florida, Forenede Stater, 33063
        • South Florida Clinical Research Institute
      • New Port Richey, Florida, Forenede Stater, 34652
        • Suncoast Clinical Research, Inc.
    • Georgia
      • Lawrenceville, Georgia, Forenede Stater, 30046
        • Balanced Life Health Care Solutions/SKYCRNG
      • Roswell, Georgia, Forenede Stater, 30076
        • Endocrine Research Solutions, Inc.
      • Woodstock, Georgia, Forenede Stater, 30189
        • North Georgia Clinical Research
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96813
        • Pacific Diabetes & Endocrine Center
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83646
        • Solaris Clinical Research
    • Iowa
      • West Des Moines, Iowa, Forenede Stater, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21239
        • MedStar Good Samaritan Hospital
    • Michigan
      • Troy, Michigan, Forenede Stater, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Missouri
      • City of Saint Peters, Missouri, Forenede Stater, 63303
        • StudyMetrix Research
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89128
        • Las Vegas Medical Research
    • New Mexico
      • Albuquerque, New Mexico, Forenede Stater, 87109
        • IMA Clinical Research
    • New York
      • Albany, New York, Forenede Stater, 12203
        • Albany Medical College, Division of Community Endocrinology
      • Albany, New York, Forenede Stater, 12208
        • Albany Stratton VA Medical Center
      • Long Island City, New York, Forenede Stater, 11106
        • NYC Research INC
    • North Carolina
      • Raleigh, North Carolina, Forenede Stater, 27609
        • Accellacare - Raleigh
    • Oregon
      • Portland, Oregon, Forenede Stater, 97210
        • Summit Headlands
    • Tennessee
      • Knoxville, Tennessee, Forenede Stater, 37909
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Dallas, Texas, Forenede Stater, 75230
        • Velocity Clinical Research, Dallas
      • DeSoto, Texas, Forenede Stater, 75115
        • Epic Medical Research - DeSoto
      • Denison, Texas, Forenede Stater, 75020
        • Soma Clinical Trials
      • Houston, Texas, Forenede Stater, 77043
        • Biopharma Informatic, LLC
      • San Antonio, Texas, Forenede Stater, 78230
        • VIP Trials
      • San Antonio, Texas, Forenede Stater, 78229
        • Diabetes and Glandular Disease Center
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22911
        • Charlottesville Medical Research
    • Washington
      • Tacoma, Washington, Forenede Stater, 98405
        • Universal Research Group
  • Grækenland
      • Thessaloniki, Grækenland, 564 29
        • 424 Military General Training Hospital
    • Attikí
      • Athens, Attikí, Grækenland, 151 25
        • Athens Medical Center
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Grækenland, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Grækenland, 570 01
        • Thermi Clinic
      • Thessaloniki, Thessaloníki, Grækenland, 546 45
        • EUROMEDICA General Clinic of Thessaloniki
      • Thessaloniki, Thessaloníki, Grækenland, 564 29
        • Papageorgiou General Hospital of Thessaloniki
    • Thessalía
      • Larissa, Thessalía, Grækenland, 41110
        • University General Hospital of Larissa
  • Indien
    • Karnataka
      • Bangalore, Karnataka, Indien, 560092
        • Medstar Speciality Hospital
      • Hubli, Karnataka, Indien, 580021
        • Karnataka Institute of Medical Sciences
    • Madhya Pradesh
      • Indore, Madhya Pradesh, Indien, 452010
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Mumbai, Maharashtra, Indien, 400008
        • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
      • Mumbai, Maharashtra, Indien, 400058
        • BSES MG Hospital
      • Nagpur, Maharashtra, Indien, 441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
      • Pune, Maharashtra, Indien, 411004
        • Sahyadri Super Speciality Hospital
    • Tamil Nadu
      • Madurai, Tamil Nadu, Indien, 625020
        • Arthur Asirvatham Hospital
    • Telangana
      • Hyderabad, Telangana, Indien, 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
  • Sydkorea
    • Kang-won-do
      • Wŏnju, Kang-won-do, Sydkorea, 26426
        • Yonsei University-Wonju Severance Christian Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Sydkorea, 13620
        • Seoul National University Bundang Hospital
    • Kyǒngsangbuk-do
      • Gyeongsan-si, Kyǒngsangbuk-do, Sydkorea, 42415
        • Yeungnam Univeristy Medical Center
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 02841
        • Korea University Anam Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 06591
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 134-090
        • Kyung Hee University Hospital at Gangdong
  • Tjekkiet
      • Hradec Králové, Tjekkiet, 500 12
        • Endokrinologie MUDr. Rehorkova s.r.o.
      • Pilsen, Tjekkiet, 326 00
        • MUDr. Jitka Zemanová - diabetologie a interna s.r.o.
      • Český Krumlov, Tjekkiet, 381 01
        • Nemocnice Cesky Krumlov
    • Central Bohemia
      • Příbram, Central Bohemia, Tjekkiet, 26201
        • Milan Kvapil s.r.o., Diabetologicka ambulance Pribram
    • Moravskosl
      • Krnov, Moravskosl, Tjekkiet, 79401
        • MUDr. Tomas Edelsberger
    • Pardubice
      • Pardubice V, Pardubice, Tjekkiet, 530 02
        • Diahelp s.r.o
    • Plzeň-město
      • Pilsen, Plzeň-město, Tjekkiet, 301 00
        • Dialine - Interni a diabetologicka ambulance
    • Praha 1
      • Prague, Praha 1, Tjekkiet, 11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
    • Praha 4
      • Prague, Praha 4, Tjekkiet, 14900
        • Milan Kvapil s.r.o., Diabetologicka ambulance
    • Praha 8
      • Prague, Praha 8, Tjekkiet, 18100
        • ResTrial s.r.o.
    • Praha-západ
      • Jílové u Prahy, Praha-západ, Tjekkiet, 252 42
        • MUDr. Sabina Palova
    • South Bohemian Region
      • České Budějovice, South Bohemian Region, Tjekkiet, 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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Har et kropsmasseindeks (BMI) ≥27,0 kilogram/kvadratmeter (kg/m²).
  • Har en historie med mindst 1 selvrapporteret mislykket diætforsøg for at tabe kropsvægt.

  • Har en diagnose af type 2-diabetes (T2D), med HbA1c ≥7 % (≥53 mmol/mol) til ≤10 % (86 mmol/mol) og er i stabil behandling for T2D i mindst 90 dage før screening, bestående af af:

    • enten kost/motion alene eller
    • op til 3 orale antihyperglykæmiske lægemidler (eksklusive dipeptidylpeptidase IV-hæmmere (DPP-4i) eller glukagon-lignende peptid-1 (GLP-1) receptoragonister (RA).

Ekskluderingskriterier:

  • Har type 1-diabetes (T1D), historie med ketoacidose eller hyperosmolær tilstand/koma eller enhver anden type diabetes undtagen T2D.
  • Få en selvrapporteret ændring i kropsvægt >5 kg (11 pund) inden for 90 dage før screening.
  • Modtager i øjeblikket eller planlægger at modtage behandling for diabetisk retinopati og/eller makulaødem (f.eks. laster fotokoagulation eller intravitreale injektioner af antivaskulære endotelvækstfaktorhæmmere).
  • Har familie (førstegradsslægtning) eller personlig historie med medullær thyreoideacancer (MTC) eller multipel endokrin neoplasi 2 (MEN2) syndrom.
  • Har haft en historie med kronisk eller akut pancreatitis.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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.
Medicin: Placebo
Indgives oralt
Eksperimentel: 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.
Medicin: Orforglipron
Indgives oralt
Andre navne:
  • LY3502970
Eksperimentel: 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.
Medicin: Orforglipron
Indgives oralt
Andre navne:
  • LY3502970
Eksperimentel: 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.
Medicin: Orforglipron
Indgives oralt
Andre navne:
  • LY3502970

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Lilly and Company

Efterforskere

  • 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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

5. juni 2023

Primær færdiggørelse (Faktiske)

8. august 2025

Studieafslutning (Faktiske)

8. august 2025

Datoer for studieregistrering

Først indsendt

15. maj 2023

Først indsendt, der opfyldte QC-kriterier

15. maj 2023

Først opslået (Faktiske)

24. maj 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserede individuelle data på patientniveau vil blive leveret i et sikkert adgangsmiljø efter godkendelse af et forskningsforslag og en underskrevet datadelingsaftale.

IPD-delingstidsramme

Tidsramme:

Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og Den Europæiske Union (EU), alt efter hvad der er senere. Data vil være tilgængelige på ubestemt tid for anmodning.

IPD-delingsadgangskriterier

Et forskningsforslag skal godkendes af et uafhængigt bedømmelsespanel, og forskere skal underskrive en datadelingsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner