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En studie av Orforglipron (LY3502970) hos voksne deltakere med fedme eller overvekt med vektrelaterte komorbiditeter (ATTAIN-1)

23. juli 2026 oppdatert av: Eli Lilly and Company

En fase 3, randomisert, dobbeltblind studie for å undersøke effektiviteten og sikkerheten til oral LY3502970 én gang daglig sammenlignet med placebo hos voksne deltakere med fedme eller overvekt med vektrelaterte komorbiditeter (ATTAIN-1)

Denne studien vil undersøke effektiviteten og sikkerheten til oral orforglipron én gang daglig hos voksne deltakere med fedme eller overvekt med vektrelaterte komorbiditeter.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

3127

Fase

  • Fase 3

Kontakter og plasseringer

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

Studiesteder

  • Brasil
      • Rio de Janeiro, Brasil, 22061-080
        • Hospital São Lucas de Copacabana
      • São Paulo, Brasil, 01228-000
        • CPQuali Pesquisa Clínica
      • São Paulo, Brasil, 04266-010
        • CEPIC - Centro Paulista de Investigação Clínica
      • São Paulo, Brasil, 05403-000
        • Hospital das Clinicas FMUSP
    • Ceará
      • Fortaleza, Ceará, Brasil, 60430-350
        • Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas
    • Espírito Santo
      • Vitória, Espírito Santo, Brasil, 29055450
        • CEDOES
    • Maranhão
      • Bequimão, Maranhão, Brasil, 65060-645
        • Hospital Sao Domingos
    • Paraná
      • Curitiba, Paraná, Brasil, 80030-480
        • Cline Research Center
      • Curitiba, Paraná, Brasil, 80045170
        • Quanta Diagnóstico e Terapia
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brasil, 90430-001
        • Nucleo de Pesquisa Clinica do Rio Grande do Sul
    • São Paulo
      • Campinas, São Paulo, Brasil, 13060-803
        • Centro de Pesquisa São Lucas
      • Jaú, São Paulo, Brasil, 17201130
        • CECIP - Centro de Estudos do Interior Paulista
      • São Bernardo do Campo, São Paulo, Brasil, 09715-090
        • Centro Multidisciplinar de Estudos Clinicos
      • Votuporanga, São Paulo, Brasil, 15501-405
        • Integral Pesquisa e Ensino
  • Forente stater
    • Arizona
      • Chandler, Arizona, Forente stater, 85225
        • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
      • Sun City West, Arizona, Forente stater, 85375
        • Clinical Research Institute of Arizona (CRI) - Sun City West
    • California
      • Concord, California, Forente stater, 94520
        • John Muir Physician Network Research Center
      • Escondido, California, Forente stater, 92025
        • AMCR Institute
      • Greenbrae, California, Forente stater, 94904
        • NorCal Medical Research, Inc
      • Huntington Park, California, Forente stater, 90255
        • Velocity Clinical Research, Huntington Park
      • Los Angeles, California, Forente stater, 90057
        • Velocity Clinical Research, Westlake
      • Montclair, California, Forente stater, 91763
        • Catalina Research Institute, LLC
      • San Ramon, California, Forente stater, 94583
        • Norcal Endocrinology & Internal Medicine
      • Tustin, California, Forente stater, 92780
        • University Clinical Investigators, Inc.
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • University of Colorado Anschutz Medical Campus
    • Florida
      • Miami, Florida, Forente stater, 33186
        • New Age Medical Research Corporation
      • Miramar, Florida, Forente stater, 33027
        • South Broward Research
      • Ocala, Florida, Forente stater, 34470
        • Renstar Medical Research
      • Tampa, Florida, Forente stater, 33619
        • Jedidiah Clinical Research - Tampa - Bay Plaza
      • Winter Park, Florida, Forente stater, 32789
        • Clinical Site Partners, LLC dba Flourish Research
    • Georgia
      • Lawrenceville, Georgia, Forente stater, 30046
        • Physicians Research Associates
      • Macon, Georgia, Forente stater, 31210
        • East Coast Institute for Research, LLC
      • Union City, Georgia, Forente stater, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Hawaii
      • Honolulu, Hawaii, Forente stater, 96814
        • East-West Medical Research Institute
    • Idaho
      • Blackfoot, Idaho, Forente stater, 83221
        • Elite Clinical Trials
    • Kansas
      • Topeka, Kansas, Forente stater, 66606
        • Cotton O'Neil Clinical Research Center
      • Topeka, Kansas, Forente stater, 66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Louisiana
      • Baton Rouge, Louisiana, Forente stater, 70808
        • Pennington Biomedical Research Center
      • Lake Charles, Louisiana, Forente stater, 70601
        • Care Access - Lake Charles
    • Maryland
      • Hyattsville, Maryland, Forente stater, 20782
        • MedStar Health Research Institute (MedStar Physician Based Research Network)
      • Rockville, Maryland, Forente stater, 20852
        • Endocrine and Metabolic Consultants
    • Michigan
      • Troy, Michigan, Forente stater, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Mississippi
      • Ridgeland, Mississippi, Forente stater, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Nevada
      • Las Vegas, Nevada, Forente stater, 89128
        • Las Vegas Medical Research
    • New York
      • Lake Success, New York, Forente stater, 11042
        • Long Island Cardiovascular Consultants
      • New York, New York, Forente stater, 10021
        • Weill Cornell Medical College
    • Oklahoma
      • Norman, Oklahoma, Forente stater, 73069
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Austin, Texas, Forente stater, 78731
        • Texas Diabetes & Endocrinology, P.A.
      • Dallas, Texas, Forente stater, 75251
        • Cedar Health Research
      • Dallas, Texas, Forente stater, 75230
        • Velocity Clinical Research, Dallas
      • Dallas, Texas, Forente stater, 75208
        • Thyroid, Endocrinology, and Diabetes
      • Houston, Texas, Forente stater, 77054
        • Juno Research
      • Shavano Park, Texas, Forente stater, 78231
        • Consano Clinical Research, LLC
      • Wylie, Texas, Forente stater, 75098
        • Soma Clinical Trials
    • Utah
      • Draper, Utah, Forente stater, 84020
        • Physicians' Research Options
    • Virginia
      • Newport News, Virginia, Forente stater, 23606
        • Health Research of Hampton Roads, Inc.
    • Washington
      • Redmond, Washington, Forente stater, 98052
        • Eastside Research Associates
  • India
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Endolife Speciality Hospitals
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Victoria Hospital, Bangalore Medical College And Research Institute
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College
    • Maharashtra
      • Nagpur, Maharashtra, India, 441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
      • Nagpur, Maharashtra, India, 440015
        • Central India Cardiology and Research Institute
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
      • Pune, Maharashtra, India, 411004
        • Sahyadri Super Speciality Hospital
      • Pune, Maharashtra, India, 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
  • Slovakia
      • Bratislava, Slovakia, 831 03
        • MediTask
    • Banská Bystrica Region
      • Lučenec, Banská Bystrica Region, Slovakia, 984 01
        • Nemocnica s poliklinikou Lucenec
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 811 08
        • Metabol KLINIK
    • Košice Region
      • Košice, Košice Region, Slovakia, 04001
        • Human Care s.r.o.
      • Trebišov, Košice Region, Slovakia, 075 01
        • ARETEUS s.r.o.
    • Košický Kr
      • Rožňava, Košický Kr, Slovakia, 048 01
        • DIAB sro
    • Presov
      • Sabinov, Presov, Slovakia, 083 01
        • MEDI-DIA s.r.o.
    • Trenčín Region
      • Púchov, Trenčín Region, Slovakia, 020 01
        • DIA-MED CENTRUM s.r.o.
  • Spania
      • Valencia, Spania, 46026
        • Hospital Universitari i Politecnic La Fe
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spania, 15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña
      • Ferrol, A Coruña [La Coruña], Spania, 15405
        • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
    • Almería
      • Almería, Almería, Spania, 04009
        • Centro Periferico de Especialidades Bola Azul
    • Andalusia
      • Málaga, Andalusia, Spania, 29010
        • Hospital Universitario Virgen de la Victoria
      • Seville, Andalusia, Spania, 41010
        • Hospital Quiron Infanta Luisa
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spania, 08916
        • Hospital Germans Trías i Pujol
      • Barcelona, Barcelona [Barcelona], Spania, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Barcelona [Barcelona], Spania, 08022
        • Centro Medico Teknon
    • Castille and León
      • Valladolid, Castille and León, Spania, 47010
        • Hospital Clínico Universitario de Valladolid
    • Cádiz
      • Sanlúcar de Barrameda, Cádiz, Spania, 11540
        • Hospital Virgen del Camino
      • Villamartín, Cádiz, Spania, 11650
        • Hospital Virgen de las Montañas
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spania, 46014
        • Hospital General Universitario de Valencia
  • Sør -Korea
    • Incheon-gw
      • Namdong-gu, Incheon-gw, Sør -Korea, 21565
        • Gachon University Gil Medical Center
    • Kyǒnggi-do
      • Ansan-si, Kyǒnggi-do, Sør -Korea, 15355
        • Korea University Ansan Hospital
      • Anyang-si, Kyǒnggi-do, Sør -Korea, 14068
        • Hallym University Sacred Heart Hospital
      • Suwon, Kyǒnggi-do, Sør -Korea, 16499
        • Ajou University Hospital
    • Kyǒngsangnam-do
      • Busan, Kyǒngsangnam-do, Sør -Korea, 50612
        • Pusan National University Yangsan Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Sør -Korea, 03080
        • Seoul National University Hospital
    • Taejǒn-Kwangyǒkshi
      • Seogu, Taejǒn-Kwangyǒkshi, Sør -Korea, 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

Deltakelseskriterier

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

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inklusjonskriterier:

  • Har en BMI

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

    • ≥27,0 kg/m² og tilstedeværelse av minst 1 av følgende vektrelaterte komorbiditeter (behandlet eller ubehandlet) ved screening:

      • Hypertensjon, dyslipidemi, obstruktiv søvnapné, kardiovaskulær sykdom (for eksempel iskemisk kardiovaskulær sykdom, New York Heart Association funksjonell klasse I-III hjertesvikt).
  • Har en historie med minst 1 selvrapportert mislykket kostholdsforsøk for å gå ned i kroppsvekt.

Ekskluderingskriterier:

  • Har type 1 diabetes, type 2 diabetes eller andre typer diabetes, historie med ketoacidose eller hyperosmolar tilstand/koma
  • Ha en selvrapportert endring i kroppsvekt >5 kg (11 pund) innen 90 dager før screening.
  • Har familie (førstegradsslektning) eller personlig historie med medullær skjoldbruskkjertelkreft (MTC) eller multippel endokrin neoplasi (MEN) 2-syndrom.
  • Har hatt en historie med kronisk eller akutt pankreatitt.

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

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

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

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

Sponsor

Eli Lilly and Company

Etterforskere

  • Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publikasjoner og nyttige lenker

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

Generelle publikasjoner

Hjelpsomme linker

Studierekorddatoer

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

Studer hoveddatoer

Studiestart (Faktiske)

5. juni 2023

Primær fullføring (Faktiske)

25. juli 2025

Studiet fullført (Antatt)

1. oktober 2027

Datoer for studieregistrering

Først innsendt

12. mai 2023

Først innsendt som oppfylte QC-kriteriene

12. mai 2023

Først lagt ut (Faktiske)

22. mai 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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

Abonnere