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Uno studio sull'orforglipron (LY3502970) in partecipanti adulti con obesità o sovrappeso con comorbidità legate al peso (ATTAIN-1)

23 luglio 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 orale una volta al giorno rispetto al placebo in partecipanti adulti con obesità o sovrappeso con comorbidità legate al peso (ATTAIN-1)

Questo studio esaminerà l'efficacia e la sicurezza di una volta al giorno per via orale o forglipron nei partecipanti adulti con obesità o sovrappeso con comorbilità legate al peso.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

3127

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

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

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

    • ≥30,0 kg/metro quadro (kg/m²),

    • ≥27,0 kg/m² e presenza di almeno 1 delle seguenti comorbilità legate al peso (trattate o non trattate) allo screening:

      • Ipertensione, dislipidemia, apnea ostruttiva del sonno, malattie cardiovascolari (ad esempio, malattia cardiovascolare ischemica, insufficienza cardiaca di classe funzionale I-III della New York Heart Association).
  • Avere una storia di almeno 1 sforzo dietetico non riuscito auto-riferito per perdere peso corporeo.

Criteri di esclusione:

  • Avere diabete di tipo 1, diabete di tipo 2 o qualsiasi altro tipo di diabete, storia di chetoacidosi o stato iperosmolare/coma
  • Avere una variazione autodichiarata del peso corporeo> 5 kg (11 libbre) entro 90 giorni prima dello screening.
  • Avere una storia familiare (parente di primo grado) o personale di carcinoma midollare della tiroide (MTC) o di sindrome da neoplasia endocrina multipla (MEN)2.
  • 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
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.
Droga: Placebo
Somministrato per via orale.
Sperimentale: 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.
Droga: Orforglipron
Somministrato per via orale.
Altri nomi:
  • LY3502970
Sperimentale: 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.
Droga: Orforglipron
Somministrato per via orale.
Altri nomi:
  • LY3502970
Sperimentale: 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.
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 (Primary Treatment Period)
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 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change From Baseline in Waist Circumference (Primary Treatment Period)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
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 "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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: Baseline, Week 176
Baseline, Week 176
Time to Onset of Type 2 Diabetes (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)
Lasso di tempo: Baseline through Week 176, Baseline through Week 190
Baseline through Week 176, Baseline through Week 190

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 8 AM - 8 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)

25 luglio 2025

Completamento dello studio (Stimato)

1 ottobre 2027

Date di iscrizione allo studio

Primo inviato

12 maggio 2023

Primo inviato che soddisfa i criteri di controllo qualità

12 maggio 2023

Primo Inserito (Effettivo)

22 maggio 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

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

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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