A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

3

Condition

Sleep Apnea Syndromes

Obesity

Diabetes Prevention

Treatment

Placebo

Retatrutide

Clinical Study ID

NCT05929079
18558
J1I-MC-GZBK
2023-503658-11-00
J1I-MC-GSA2
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to is to evaluate the efficacy and safety of retatrutide in participants with type 2 diabetes in participants who have obesity or overweight (J1I-MC-GZBK master protocol) including a subset of participants who have obstructive sleep apnea (OSA) (J1I-MC-GSA2). The study will last about 89 weeks and will include up to 24 visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a body mass index (BMI) greater than or equal to 27.0 kilogram/square meter (kg/m ²)

  • Have Type 2 Diabetes (T2D)

  • Are on stable treatment for T2D for at least 90 days

  • Have a history of at least one unsuccessful dietary effort to lose body weight.

GSA2 Inclusion Criteria

  • Previously diagnosed with OSA

  • Have AHI ≥15 on polysomnography at screening (definition of moderate-to-severe OSA)

  • For participants not on positive airway pressure (PAP) therapy: unable or unwillingto use PAP therapy and have not used PAP for at least 4 weeks prior to screening.

  • If on PAP therapy, have been on PAP therapy for at least 3 consecutive months priorto screening, and willing to temporarily stop using PAP therapy for approximately 7days prior to each of the sleep study (PSG) visits.

Exclusion

Exclusion Criteria:

  • Have a self-reported or documented change in body weight >5 kg (11 pounds) within 90days.

  • Have taken weight loss drugs, including over-the-counter medications, within 90 daysprior to screening.

  • Have a prior or planned surgical treatment for obesity.

  • Have Type 1 diabetes

  • Have a family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia syndrome type 2 (MEN-2)

  • Have had pancreatitis

GSA2 Exclusion Criteria

  • Use stimulants (for example, modafinil, armodafinil, solriamfetol, pitolisant,amphetamine) less than 3 months prior to screening.

  • Use hypnotics, mirtazapine, opioids, trazodone, and zonisamide less than 3 monthsprior to screening.

  • Use a dental appliance or other device to treat OSA other than PAP therapy.

Study Design

Total Participants: 1000
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
July 11, 2023
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1120AAC
    Argentina

    Site Not Available

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires C1425AGC
    Argentina

    Site Not Available

  • Consultorio de Investigación Clínica EMO SRL

    Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires 1405
    Argentina

    Site Not Available

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, La Pampa 6300
    Argentina

    Site Not Available

  • Emeritus Research

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Optimus Clinical Research

    Botany, New South Wales 2019
    Australia

    Site Not Available

  • Woolcock Institute of Medical Research

    Macquarie Park, New South Wales 2113
    Australia

    Site Not Available

  • The AIM Centre / Hunter Diabetes Centre

    Merewether, New South Wales 2291
    Australia

    Site Not Available

  • Woolcock Institute of Medical Research

    Sydney, New South Wales 2037
    Australia

    Site Not Available

  • Core Research Group

    Brisbane, Queensland 4064
    Australia

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  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland 4029
    Australia

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  • Nightingale Research

    Adelaide, South Australia 5000
    Australia

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  • Flinders University

    Bedford Park, South Australia 5042
    Australia

    Site Not Available

  • Southern Adelaide Diabetes & Endocrine Services

    Oaklands Park, South Australia 5046
    Australia

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  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

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    Camberwell, Victoria 3124
    Australia

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    Heidelberg West, Victoria 3081
    Australia

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    Joondalup, Western Australia 6027
    Australia

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    Joondalup, Western Australia 6027
    Australia

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    Sao Paulo, São Paulo 01236030
    Brazil

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    São Paulo, 04266-010
    Brazil

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    São Paulo, 01228-000
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    Beijing, Beijing 100730
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    Harbin, Heilongjiang 150001
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    Zhengzhou, Henan 450014
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    Bao Tou, Inner Mongolia 014040
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    Baotou, Inner Mongolia 014040
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    Nanjing, Jiangsu 210006
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    Nanjing, Jiangsu 210011
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    Changchun, Jilin 130021
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    Xi'an, Shaanxi 710077
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    Shanghai, Shanghai 201200
    China

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    Cheng Du, Sichuan 610041
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    ChengDu, Sichuan 610041
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    Chengdu, Sichuan 610041
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    Ningbo, Zhejiang 315010
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    Raipur, Chhattisgarh 492099
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    Ahmedabad, Gujarat 380013
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    Ahmedabad, Gujarat 380006
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    Ahmedabad, Gujarat 380054
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    Bangalore, Karnataka 560092
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    Hubli, Karnataka 580021
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    Mysore, Karnataka 570001
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    Indore, Madhya Pradesh 452008
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    Indore, Madhya Pradesh 452008
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    Jaipur, Rajasthan 302004
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    Chennai, Tamil Nadu 600086
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    Vellore, Tamil Nadu 632004
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    Hyderabad, Telangana 500034
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    Hyderabad, Telangana 500072
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    Kolkata, West Bengal 700020
    India

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    Ansan-si, Kyǒnggi-do 15355
    Korea, Republic of

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    Guri-si, Kyǒnggi-do 11923
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    Gyeongsan-si, Kyǒngsangbuk-do 42415
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    Seoul, Seoul-teuk 3722
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    Seoul, Seoul-teukbyeolsi [Seoul] 03080
    Korea, Republic of

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  • Ulsan University Hospital

    Ulsan, Ulsan-Kwangyǒkshi 44033
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  • Centro de Investigacion en Artritis y Osteoporosis SC

    Mexicali, Baja California 21200
    Mexico

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    Mexico City, Distrito Federal 11650
    Mexico

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    Mexico City, Distrito Federal 06700
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    Guadalajara, Jalisco 44670
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    Guadalajara, Jalisco 44670
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    Cuernavaca, Morelos 62250
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    Monterrey, Nuevo León 64060
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    Monterrey, Nuevo León 64460
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    Monterrey, Nuevo León 64460
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    Mérida, Yucatán 97070
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    Mérida, Yucatán 97070
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    Chihuahua, 31110
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    Veracruz, 91910
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    Oradea, Bihor 410147
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    Almeria, Almería 04009
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    Málaga, Andalucía 29009
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    León, Castilla Y León 24071
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    Alcalá de Henares, Madrid, Comunidad De 28805
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    Madrid, Madrid, Comunidad De 28034
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    Seville, Sevilla 41950
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    Sevilla, 41013
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    Kaohsiung Niao Sung Dist, Kaohsiung 83301
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    Taichung City, Taichung 402
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    Tainan City, Tainan 71004
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    Taipei City, Taipei 11217
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    Kaohsiung, 83301
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    Taipei, 11217
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    Little Rock, Arkansas 72211
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    Cerritos, California 90703
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    Los Angeles, California 90057
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    Waterbury, Connecticut 06708
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    Brandon, Florida 33511
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    Fleming Island, Florida 32003
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    Fort Lauderdale, Florida 33308
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    Miami, Florida 33186
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    Miami Beach, Florida 33140
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    Ocala, Florida 34470
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    Pompano Beach, Florida 33060
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    West Palm Beach, Florida 33409
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    Winter Park, Florida 32789
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  • NeuroTrials Research Inc

    Atlanta, Georgia 30328
    United States

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  • Centricity Research Rincon Pulmonology

    Rincon, Georgia 31406
    United States

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  • East-West Medical Research Institute

    Honolulu, Hawaii 96814
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  • Brengle Family Medicine

    Indianapolis, Indiana 46260
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  • MedVadis Research Corporation

    Waltham, Massachusetts 02451
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    Saint Peters, Missouri 63303
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    Las Vegas, Nevada 89128
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    New Windsor, New York 12553
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  • Monroe Biomedical Research

    Monroe, North Carolina 28112
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    Morehead City, North Carolina 28557
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    Fargo, North Dakota 58104
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    Cincinnati, Ohio 45212
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    Cincinnati, Ohio 45212
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    Cincinnati, Ohio 45245
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  • Office 18

    Pittsburgh, Pennsylvania 15236
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    Pittsburgh, Pennsylvania 15236
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    Uniontown, Pennsylvania 15401
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    Greenville, South Carolina 29607
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    Myrtle Beach, South Carolina 29572
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    Spartanburg, South Carolina 29301
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  • FutureSearch Trials of Neurology

    Austin, Texas 78731
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    Dallas, Texas 75230
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    Active - Recruiting

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    Dallas, Texas 75230
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    Ogden, Utah 84405
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    Bellevue, Washington 98007
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