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En undersøgelse af Orforglipron (LY3502970) hos voksne deltagere med fedme eller overvægt med vægtrelaterede komorbiditeter (ATTAIN-1)

23. juli 2026 opdateret af: Eli Lilly and Company

Et fase 3, randomiseret, dobbeltblindt studie for at undersøge effektiviteten og sikkerheden af ​​oral LY3502970 én gang dagligt sammenlignet med placebo hos voksne deltagere med fedme eller overvægt med vægtrelaterede komorbiditeter (ATAIN-1)

Denne undersøgelse vil undersøge effektiviteten og sikkerheden af ​​oral orforglipron én gang dagligt hos voksne deltagere med fedme eller overvægt med vægtrelaterede følgesygdomme.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3127

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

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

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 BMI

    • ≥30,0 kilogram/kvadratmeter (kg/m²),

    • ≥27,0 kg/m² og tilstedeværelse af mindst 1 af følgende vægtrelaterede følgesygdomme (behandlet eller ubehandlet) ved screening:

      • Hypertension, dyslipidæmi, obstruktiv søvnapnø, kardiovaskulær sygdom (for eksempel iskæmisk kardiovaskulær sygdom, New York Heart Association Functional Class I-III hjertesvigt).
  • Har en historie med mindst 1 selvrapporteret mislykket diætforsøg for at tabe kropsvægt.

Ekskluderingskriterier:

  • Har type 1-diabetes, type 2-diabetes eller enhver anden type diabetes, historie med ketoacidose eller hyperosmolær tilstand/koma
  • Få en selvrapporteret ændring i kropsvægt >5 kg (11 pund) inden for 90 dage før screening.
  • Har familie (førstegradsslægtning) eller personlig historie med medullær skjoldbruskkirtelkræft (MTC) eller multipel endokrin neoplasi (MEN)2 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
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally once daily (QD), for a period of 72 weeks.
Medicin: Placebo
Indgives oralt.
Eksperimentel: 6 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 milligrams (mg) and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
Medicin: Orforglipron
Indgives oralt.
Andre navne:
  • LY3502970
Eksperimentel: 12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
Medicin: Orforglipron
Indgives oralt.
Andre navne:
  • LY3502970
Eksperimentel: 36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
Medicin: Orforglipron
Indgives oralt.
Andre navne:
  • LY3502970

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change From Baseline in Body Weight (Primary Treatment Period)
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 geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72

Sekundære resultatmål

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

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 8 AM - 8 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)

25. juli 2025

Studieafslutning (Anslået)

1. oktober 2027

Datoer for studieregistrering

Først indsendt

12. maj 2023

Først indsendt, der opfyldte QC-kriterier

12. maj 2023

Først opslået (Faktiske)

22. maj 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

14. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

ata 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