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Uno studio sull'orforglipron nei partecipanti adulti con obesità o sovrappeso e diabete di tipo 2 (ATTAIN-2)

3 settembre 2026 aggiornato da: Eli Lilly and Company

Uno studio di fase 3, randomizzato, in doppio cieco per indagare l'efficacia e la sicurezza di LY3502970 una volta al giorno per via orale rispetto al placebo in partecipanti adulti con obesità o sovrappeso e diabete di tipo 2 (ATTAIN-2)

Questo studio esaminerà la sicurezza e l'efficacia del trattamento orale una volta al giorno con orforglipron rispetto al placebo sul peso corporeo nei partecipanti adulti con obesità o sovrappeso e diabete di tipo 2. Lo studio durerà circa 77 settimane e potrà includere fino a 22 visite.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1613

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Avere un indice di massa corporea (BMI) ≥27,0 kg/metro quadrato (kg/m²).
  • Avere una storia di almeno 1 sforzo dietetico non riuscito auto-riferito per perdere peso corporeo.

  • Avere una diagnosi di diabete di tipo 2 (T2D), con HbA1c ≥7% (≥53 mmol/mol) a ≤10% (86 mmol/mol) e sono in trattamento stabile per T2D per almeno 90 giorni prima dello screening, consistente Di:

    • o dieta/esercizio da solo o
    • fino a 3 farmaci antiiperglicemici orali (esclusi gli inibitori della dipeptidil peptidasi IV (DPP-4i) o gli agonisti del recettore del peptide-1 simile al glucagone (GLP-1) (RA).

Criteri di esclusione:

  • Avere diabete di tipo 1 (T1D), storia di chetoacidosi o stato/coma iperosmolare o qualsiasi altro tipo di diabete eccetto T2D.
  • Avere una variazione autodichiarata del peso corporeo> 5 kg (11 libbre) entro 90 giorni prima dello screening.
  • Sono attualmente in trattamento o stanno pianificando di ricevere un trattamento per la retinopatia diabetica e/o l'edema maculare (ad esempio, laster fotocoagulazione o iniezioni intravitreali di inibitori del fattore di crescita dell'endotelio antivascolare).
  • Avere una storia familiare (parente di primo grado) o personale di carcinoma midollare della tiroide (MTC) o di sindrome da neoplasia endocrina multipla 2 (MEN2).
  • Hanno avuto una storia di pancreatite cronica o acuta.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore 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.
Droga: Placebo
Somministrato per via orale
Sperimentale: 6 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
Droga: Orforglipron
Somministrato per via orale
Altri nomi:
  • LY3502970
Sperimentale: 12 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
Droga: Orforglipron
Somministrato per via orale
Altri nomi:
  • LY3502970
Sperimentale: 36 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
Droga: Orforglipron
Somministrato per via orale
Altri nomi:
  • LY3502970

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percent Change From Baseline in Body Weight
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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) %
Lasso di tempo: 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)
Lasso di tempo: 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%)
Lasso di tempo: 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%)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eli Lilly and Company

Investigatori

  • Direttore dello studio: 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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Collegamenti utili

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

5 giugno 2023

Completamento primario (Effettivo)

8 agosto 2025

Completamento dello studio (Effettivo)

8 agosto 2025

Date di iscrizione allo studio

Primo inviato

15 maggio 2023

Primo inviato che soddisfa i criteri di controllo qualità

15 maggio 2023

Primo Inserito (Effettivo)

24 maggio 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

I dati anonimi a livello di singolo paziente saranno forniti in un ambiente di accesso sicuro previa approvazione di una proposta di ricerca e di un accordo di condivisione dei dati firmato.

Periodo di condivisione IPD

Lasso di tempo:

I dati sono disponibili 6 mesi dopo la pubblicazione primaria e l'approvazione dell'indicazione studiata negli Stati Uniti e nell'Unione Europea (UE), se successiva. I dati saranno disponibili a tempo indeterminato per la richiesta.

Criteri di accesso alla condivisione IPD

Una proposta di ricerca deve essere approvata da un comitato di revisione indipendente e i ricercatori devono firmare un accordo di condivisione dei dati.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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