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En studie av Orforglipron (LY3502970) hos vuxna deltagare med fetma eller övervikt med viktrelaterade komorbiditeter (ATTAIN-1)

23 juli 2026 uppdaterad av: Eli Lilly and Company

En fas 3, randomiserad, dubbelblind studie för att undersöka effektiviteten och säkerheten av oral LY3502970 en gång dagligen jämfört med placebo hos vuxna deltagare med fetma eller övervikt med viktrelaterade komorbiditeter (ATTAIN-1)

Denna studie kommer att undersöka effektiviteten och säkerheten av oral orforglipron en gång dagligen hos vuxna deltagare med fetma eller övervikt med viktrelaterade komorbiditeter.

Studieöversikt

Status

Aktiv, inte rekryterande

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

3127

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • 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
  • Förenta staterna
    • Arizona
      • Chandler, Arizona, Förenta staterna, 85225
        • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
      • Sun City West, Arizona, Förenta staterna, 85375
        • Clinical Research Institute of Arizona (CRI) - Sun City West
    • California
      • Concord, California, Förenta staterna, 94520
        • John Muir Physician Network Research Center
      • Escondido, California, Förenta staterna, 92025
        • AMCR Institute
      • Greenbrae, California, Förenta staterna, 94904
        • NorCal Medical Research, Inc
      • Huntington Park, California, Förenta staterna, 90255
        • Velocity Clinical Research, Huntington Park
      • Los Angeles, California, Förenta staterna, 90057
        • Velocity Clinical Research, Westlake
      • Montclair, California, Förenta staterna, 91763
        • Catalina Research Institute, LLC
      • San Ramon, California, Förenta staterna, 94583
        • Norcal Endocrinology & Internal Medicine
      • Tustin, California, Förenta staterna, 92780
        • University Clinical Investigators, Inc.
    • Colorado
      • Aurora, Colorado, Förenta staterna, 80045
        • University of Colorado Anschutz Medical Campus
    • Florida
      • Miami, Florida, Förenta staterna, 33186
        • New Age Medical Research Corporation
      • Miramar, Florida, Förenta staterna, 33027
        • South Broward Research
      • Ocala, Florida, Förenta staterna, 34470
        • Renstar Medical Research
      • Tampa, Florida, Förenta staterna, 33619
        • Jedidiah Clinical Research - Tampa - Bay Plaza
      • Winter Park, Florida, Förenta staterna, 32789
        • Clinical Site Partners, LLC dba Flourish Research
    • Georgia
      • Lawrenceville, Georgia, Förenta staterna, 30046
        • Physicians Research Associates
      • Macon, Georgia, Förenta staterna, 31210
        • East Coast Institute for Research, LLC
      • Union City, Georgia, Förenta staterna, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Hawaii
      • Honolulu, Hawaii, Förenta staterna, 96814
        • East-West Medical Research Institute
    • Idaho
      • Blackfoot, Idaho, Förenta staterna, 83221
        • Elite Clinical Trials
    • Kansas
      • Topeka, Kansas, Förenta staterna, 66606
        • Cotton O'Neil Clinical Research Center
      • Topeka, Kansas, Förenta staterna, 66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Louisiana
      • Baton Rouge, Louisiana, Förenta staterna, 70808
        • Pennington Biomedical Research Center
      • Lake Charles, Louisiana, Förenta staterna, 70601
        • Care Access - Lake Charles
    • Maryland
      • Hyattsville, Maryland, Förenta staterna, 20782
        • MedStar Health Research Institute (MedStar Physician Based Research Network)
      • Rockville, Maryland, Förenta staterna, 20852
        • Endocrine and Metabolic Consultants
    • Michigan
      • Troy, Michigan, Förenta staterna, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Mississippi
      • Ridgeland, Mississippi, Förenta staterna, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Nevada
      • Las Vegas, Nevada, Förenta staterna, 89128
        • Las Vegas Medical Research
    • New York
      • Lake Success, New York, Förenta staterna, 11042
        • Long Island Cardiovascular Consultants
      • New York, New York, Förenta staterna, 10021
        • Weill Cornell Medical College
    • Oklahoma
      • Norman, Oklahoma, Förenta staterna, 73069
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Austin, Texas, Förenta staterna, 78731
        • Texas Diabetes & Endocrinology, P.A.
      • Dallas, Texas, Förenta staterna, 75251
        • Cedar Health Research
      • Dallas, Texas, Förenta staterna, 75230
        • Velocity Clinical Research, Dallas
      • Dallas, Texas, Förenta staterna, 75208
        • Thyroid, Endocrinology, and Diabetes
      • Houston, Texas, Förenta staterna, 77054
        • Juno Research
      • Shavano Park, Texas, Förenta staterna, 78231
        • Consano Clinical Research, LLC
      • Wylie, Texas, Förenta staterna, 75098
        • Soma Clinical Trials
    • Utah
      • Draper, Utah, Förenta staterna, 84020
        • Physicians' Research Options
    • Virginia
      • Newport News, Virginia, Förenta staterna, 23606
        • Health Research of Hampton Roads, Inc.
    • Washington
      • Redmond, Washington, Förenta staterna, 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
  • Slovakien
      • Bratislava, Slovakien, 831 03
        • MediTask
    • Banská Bystrica Region
      • Lučenec, Banská Bystrica Region, Slovakien, 984 01
        • Nemocnica s poliklinikou Lucenec
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakien, 811 08
        • Metabol KLINIK
    • Košice Region
      • Košice, Košice Region, Slovakien, 04001
        • Human Care s.r.o.
      • Trebišov, Košice Region, Slovakien, 075 01
        • ARETEUS s.r.o.
    • Košický Kr
      • Rožňava, Košický Kr, Slovakien, 048 01
        • DIAB sro
    • Presov
      • Sabinov, Presov, Slovakien, 083 01
        • MEDI-DIA s.r.o.
    • Trenčín Region
      • Púchov, Trenčín Region, Slovakien, 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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inklusionskriterier:

  • Har ett BMI

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

    • ≥27,0 kg/m² och förekomst av minst 1 av följande viktrelaterade komorbiditeter (behandlade eller obehandlade) vid screening:

      • Hypertoni, dyslipidemi, obstruktiv sömnapné, hjärt-kärlsjukdom (till exempel ischemisk hjärt-kärlsjukdom, New York Heart Association Functional Class I-III hjärtsvikt).
  • Har en historia av minst 1 självrapporterad misslyckad dietförsök för att gå ner i vikt.

Exklusions kriterier:

  • Har typ 1-diabetes, typ 2-diabetes eller någon annan typ av diabetes, historia av ketoacidos eller hyperosmolärt tillstånd/koma
  • Har en självrapporterad förändring i kroppsvikt >5 kg (11 pund) inom 90 dagar före screening.
  • Har familj (första gradens släkting) eller personlig historia av medullär sköldkörtelcancer (MTC) eller multipel endokrin neoplasi (MEN) 2-syndrom.
  • Har haft en historia av kronisk eller akut pankreatit.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Placebo-jämförare: 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.
Läkemedel: Placebo
Administreras oralt.
Experimentell: 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.
Läkemedel: Orforglipron
Administreras oralt.
Andra namn:
  • LY3502970
Experimentell: 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.
Läkemedel: Orforglipron
Administreras oralt.
Andra namn:
  • LY3502970
Experimentell: 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.
Läkemedel: Orforglipron
Administreras oralt.
Andra namn:
  • LY3502970

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percent Change From Baseline in Body Weight (Primary Treatment Period)
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change From Baseline in Waist Circumference (Primary Treatment Period)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline, Week 176
Baseline, Week 176
Time to Onset of Type 2 Diabetes (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)
Tidsram: Baseline through Week 176, Baseline through Week 190
Baseline through Week 176, Baseline through Week 190

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Eli Lilly and Company

Utredare

  • Studierektor: 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 och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

5 juni 2023

Primärt slutförande (Faktisk)

25 juli 2025

Avslutad studie (Beräknad)

1 oktober 2027

Studieregistreringsdatum

Först inskickad

12 maj 2023

Först inskickad som uppfyllde QC-kriterierna

12 maj 2023

Första postat (Faktisk)

22 maj 2023

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

14 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 juli 2026

Senast verifierad

1 juli 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

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

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

Anonymiserade individuella patientnivådata kommer att tillhandahållas i en säker åtkomstmiljö efter godkännande av ett forskningsförslag och ett undertecknat datadelningsavtal.

Tidsram för IPD-delning

ata är tillgängliga 6 månader efter den primära publiceringen och godkännandet av indikationen som studerats i USA och Europeiska unionen (EU), beroende på vilket som inträffar senare. Data kommer att vara tillgängliga på obestämd tid för begäran.

Kriterier för IPD Sharing Access

Ett forskningsförslag måste godkännas av en oberoende granskningspanel och forskare måste underteckna ett datadelningsavtal.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Ja

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera