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TRIUMPH-1: A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05929066
Collaborator
(none)
2,100
Enrollment
169
Locations
4
Arms
33.2
Anticipated Duration (Months)
12.4
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)
Anticipated Study Start Date :
Aug 7, 2023
Anticipated Primary Completion Date :
Apr 15, 2026
Anticipated Study Completion Date :
May 13, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Retatrutide Dose 1

Participants will receive retatrutide subcutaneously (SC).

Drug: Retatrutide
Administered SC
Other Names:
  • LY3437943

    		•
    Experimental: Retatrutide Dose 2

    Participants will receive retatrutide SC.

    Drug: Retatrutide
    Administered SC
    Other Names:
  • LY3437943

    		•
    Experimental: Retatrutide Dose 3

    Participants will receive retatrutide SC.

    Drug: Retatrutide
    Administered SC
    Other Names:
  • LY3437943

    		•
    Placebo Comparator: Placebo

    Participants will receive placebo.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percent Change From Baseline in Body Weight [Baseline, Week 80]

    2. Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset [Baseline, Week 80]

    3. Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset [Baseline, Week 80]

    Secondary Outcome Measures

    1. Change from Baseline in Body Mass Index (BMI) [Baseline, Week 80]

    2. Change from Baseline in Waist Circumference [Baseline, Week 80]

    3. Change from Baseline in Systolic Blood Pressure (SBP) [Baseline, Week 80]

    4. Percent Change form Baseline in Fasting Insulin [Baseline, Week 80]

    5. Change from Baseline in HbA1c [Baseline, Week 80]

    6. Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score [Baseline, Week 80]

    7. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) [Baseline through Week 80]

      AUC is presented as a single average measure of AUC across the study duration.

    8. Change from Baseline in the WOMAC Physical Function Subscale Score for GOA1 Subset [Baseline, Week 80]

    9. Change from Baseline in Average Pain Intensity Numeric Rating Scale (API-NRS) Score for GOA1 Subset [Baseline, Week 80]

    10. Change from Baseline in Worst Pain Intensity Numeric Rating Scale (WPI-NRS) Score for GOA1 Subset [Baseline, Week 80]

    11. Percent Change from Baseline in AHI for GSA1 Subset [Baseline, Week 80]

    12. A Hierarchical Combination of Functional Outcomes of Sleep Questionnaire (FOSQ) 10 Score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score for GSA1 Subset [Baseline to Week 80]

      A hierarchical combination of change from baseline in the FOSQ 10 score, FOSQ Vigilance Domain Score, and FOSQ Activity Level Domain Score will be assessed by the win ratio. The reported unit will be the total "wins" for each treatment group from performing a hierarchical comparison of the components.

    13. Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA1 Subset [Baseline to Week 80]

    14. Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA1 Subset [Week 80]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:

    • hypertension

    • dyslipidemia

    • obstructive sleep apnea, or

    • cardiovascular disease

    • History of of at least one unsuccessful dietary effort to reduce body weight

    GOA1 Inclusion Criteria:

    • Have index knee pain for >12 weeks prior to screening, and presence of index knee pain for >15 days over the previous month

    • Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening

    • Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.

    GSA1 Inclusion Criteria:

    • Previously diagnosed with OSA

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

    • For participants not on positive airway pressure (PAP) therapy: unable or unwilling to 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 prior to screening, and willing to temporarily stop using PAP therapy for approximately 7 days prior to each of the sleep study (PSG) visits.

    Exclusion Criteria:

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

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

    • Have a prior or planned surgical treatment for obesity.

    • Have diabetes mellitus.

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

    • Have had pancreatitis.

    GOA1 exclusion criteria

    • Have had steroid joint injections within 90 days of screening.

    • Have had other joint injections and procedures within 6 months of screening.

    • Have joint disease other than osteoarthritis.

    GSA1 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 months prior to screening.

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Central Phoenix Medical Clinic Phoenix Arizona United States 85020
    2 Arizona Research Center Phoenix Arizona United States 85053
    3 Medical Investigations Little Rock Arkansas United States 72211
    4 Valley Research Fresno California United States 93720
    5 Artemis Institute for Clinical Research San Diego California United States 92103
    6 University of Colorado Anschutz Medical Campus Aurora Colorado United States 80045
    7 Yale University School of Medicine New Haven Connecticut United States 06519
    8 Chase Medical Research, LLC Waterbury Connecticut United States 06708
    9 Teradan Clinical Trials, LLC Brandon Florida United States 33511
    10 Suncoast Research Group Miami Florida United States 33135
    11 New Horizon Research Center Miami Florida United States 33165
    12 Clinical Neuroscience Solutions, Inc. Orlando Florida United States 32801
    13 Progressive Medical Research Port Orange Florida United States 32127
    14 NeuroTrials Research Inc Atlanta Georgia United States 30328
    15 North Georgia Clinical Research Woodstock Georgia United States 30189
    16 East-West Medical Research Institute Honolulu Hawaii United States 96814
    17 Northwestern University Chicago Illinois United States 60611
    18 Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative Springfield Illinois United States 62711
    19 Brengle Family Medicine Indianapolis Indiana United States 46260
    20 Cotton O'Neil Clinical Research Center Topeka Kansas United States 66606
    21 MedVadis Research Corporation Waltham Massachusetts United States 02451
    22 Great Lakes Research Group, Inc. Bay City Michigan United States 48706
    23 StudyMetrix Research Saint Peters Missouri United States 63303
    24 Clinvest Research LLC Springfield Missouri United States 65807
    25 Palm Research Center Tenaya Las Vegas Nevada United States 89128
    26 Rochester Clinical Research, Inc. Rochester New York United States 14609
    27 Carteret Medical Group Morehead City North Carolina United States 28557
    28 Trial Management Associates - Wilmington - Floral Parkway Wilmington North Carolina United States 28403
    29 Lillestol Research Fargo North Dakota United States 58104
    30 Altoona Center For Clinical Research Duncansville Pennsylvania United States 16635
    31 Tribe Clinical Research, LLC Greenville South Carolina United States 29607
    32 Tribe Clinical Research - Spartanburg Spartanburg South Carolina United States 29301
    33 Vanderbilt Health One Hundred Oaks Nashville Tennessee United States 37204
    34 FutureSearch Trials of Neurology Austin Texas United States 78731
    35 Juno Research Houston Texas United States 77040
    36 Advanced Research Institute Ogden Utah United States 84405
    37 Northwest Clinical Research Center Bellevue Washington United States 98007
    38 Rainier Clinical Research Center Renton Washington United States 98057
    39 Emeritus Research Botany New South Wales Australia 2019
    40 The AIM Centre / Hunter Diabetes Centre Merewether New South Wales Australia 2291
    41 Logan Hospital Meadowbrook Queensland Australia 4131
    42 Fusion Clinical Research Adelaide South Australia Australia 5000
    43 Nightingale Research Adelaide South Australia Australia 5000
    44 Emeritus Research Camberwell Victoria Australia 3124
    45 Barwon Health Geelong Victoria Australia 3220
    46 CPCLIN Sao Paulo São Paulo Brazil 01228-200
    47 CPQuali Pesquisa Clínica São Paulo Brazil 01228-000
    48 CEPIC - Centro Paulista de Investigação Clínica São Paulo Brazil 04266-010
    49 Aggarwal and Associates Limited Brampton Ontario Canada L6T 0G1
    50 Dr. Steven V. Zizzo Medicine Professional Corporation Hamilton Ontario Canada L8J 0B6
    51 Wharton Medical Clinic Hamilton Ontario Canada L8L 5G8
    52 Your Research Network Niagara Falls Ontario Canada L2H 1H5
    53 Bluewater Clinical Research Group Inc. Sarnia Ontario Canada N7T 4X3
    54 Canadian Phase Onward Toronto Ontario Canada M3J 0K2
    55 Centre de Recherche Clinique de Laval Laval Quebec Canada H7T 2P5
    56 Clinique de médecine Urbaine du Quartier Latin Montreal Quebec Canada H2L 4E9
    57 C.I.C. Mauricie inc. Trois-Rivières Quebec Canada G8T 7A1
    58 Beijing Friendship Hospital Affiliate of Capital University Beijing Beijing China 100050
    59 The First Affiliated Hospital of Henan University of Science &Technology Luoyang Henan China 471003
    60 The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450014
    61 Nanjing First Hospital Nanjing Jiangsu China 210006
    62 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
    63 Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China 212000
    64 The First Hospital of Jilin University Changchun Jilin China 130021
    65 The Fourth Hospital of Harbin Medical University Harbin Nangang District China 150001
    66 The First Affiliated Hospital of Xi'an Medical University Xi'an Shaanxi China 710077
    67 Shanghai Tongji Hospital Shanghai Shanghai China 200065
    68 Shanghai Sixth People's Hospital Shanghai Shanghai China
    69 West China Hospital of Sichuan University Chengdu Sichuan China 610041
    70 Tianjin Medical University General Hospital Tianjin Tianjin China 300052
    71 Xinjiang Uygur Autonomous Region Hospital of Chinese Traditional Medicine Urumqi Xinjiang China 830000
    72 The First Affiliated Hospital of Xinjiang Medical University Ürümqi Xinjiang China 830054
    73 Ningbo First Hospital Ningbo Zhejiang China 315010
    74 The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China 325000
    75 Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Szeged Csongrád Hungary 6725
    76 Regia Med Kft Szekesfehervar Fejér Hungary 8000
    77 Medifarma 98 Kft Nyiregyhaza Nyíregyháza Hungary 4400
    78 DRC Gyógyszervizsgáló Központ Balatonfüred Veszprém Hungary 8230
    79 Óbudai Egészségügyi Centrum Budapest Hungary 1036
    80 ClinDiab Kft. Budapest Hungary 1089
    81 Debreceni Egyetem - Kenézy Gyula Egyetemi Oktatókórház Debrecen Hungary 4031
    82 Debreceni Egyetem Klinikai Kozpont Debrecen Hungary 4032
    83 Endolife Speciality Hospitals Guntur Andhra Pradesh India 522001
    84 Avron Hospitals Ahmedabad Gujarat India 380013
    85 Surat Institute of Digestive Sciences Hospitals Surat Gujarat India 395002
    86 Karnataka Institute of Medical Sciences Hubli Karnataka India 580021
    87 Indian Institute of Diabetes Thiruvananthapuram Kerala India 695031
    88 Jothydev's Diabetes and Research Center Trivandrum Kerala India 695032
    89 Grant Govt. Medical College & Sir J. J. Group of Hospitals Mumbai Maharashtra India 400008
    90 Wockhardt Hospital - Mumbai Central Mumbai Maharashtra India 400011
    91 Government Medical College And Hospital - Nagpur Nagpur Maharashtra India 440009
    92 Deenanath Mangeshkar Hospital & Research Centre Pune Maharashtra India 411004
    93 Chellaram Diabetes Institute Pune Maharashtra India 411021
    94 Lifepoint Multispeciality Hospital Pune Maharashtra India 411057
    95 All India Institute of Medical Sciences Bhubaneswar Odisha India 751019
    96 Eternal Heart Care Center and Research Institute Jaipur Rajasthan India 302020
    97 Christian Medical College Vellore Vellore Tamil Nadu India 632004
    98 ILS Hospitals Kolkata West Bengal India 700064
    99 Post Graduate Institute of Medical Education & Research (PGIMER) Chandigarh India 160012
    100 Gachon University Gil Medical Center Namdong Incheon-gw Korea, Republic of 21565
    101 Korea University Ansan Hospital Ansan-si Kyǒnggi-do Korea, Republic of 15355
    102 Hallym University Sacred Heart Hospital Anyang-si Kyǒnggi-do Korea, Republic of 14068
    103 Hanyang University Guri Hospital Guri-si Kyǒnggi-do Korea, Republic of 11923
    104 Seoul National University Bundang Hospital Seongnam Kyǒnggi-do Korea, Republic of 13620
    105 Ajou University Hospital Suwon Kyǒnggi-do Korea, Republic of 16499
    106 Pusan National University Yangsan Hospital Busan Kyǒngsangnam-do Korea, Republic of 50612
    107 Kangbuk Samsung Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 03181
    108 Korea University Guro Hospital Seoul Seoul-teukbyeolsi [Seoul] Korea, Republic of 08308
    109 Kyungpook National University Hospital Junggu Taegu-Kwangyǒkshi Korea, Republic of 41944
    110 Eulji University Hospital Daejeon Taejǒn-Kwangyǒkshi Korea, Republic of 01830
    111 Konyang University Hospital Seogu Taejǒn-Kwangyǒkshi Korea, Republic of 35365
    112 Ulsan University Hospital Ulsan Ulsan-Kwangyǒkshi Korea, Republic of 44033
    113 Centro de Investigacion en Artritis y Osteoporosis SC Mexicali Baja California Mexico 21200
    114 RM Pharma Specialists Mexico City Distrito Federal Mexico 03100
    115 Clinica Omega Mexico City Distrito Federal Mexico 06700
    116 Diseno y Planeacion en Investigacion Medica Guadalajara Jalisco Mexico 44130
    117 Clinica de Investigacion en Reumatologia y Obesidad S. C. Guadalajara Jalisco Mexico 44650
    118 Private Practice - Dr. Arechavaleta Granell Maria del Rosario Guadalajara Jalisco Mexico 44670
    119 Unidad de Investigación Clínica y Atención Médica HEPA Guadalajara Jalisco Mexico 44670
    120 Instituto de Diabetes, Obesidad y Nutricion Cuernavaca Morelos Mexico 62250
    121 Unidad biomedica avanzada monterrey Monterrey Nuevo León Mexico 64460
    122 Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Monterrey Nuevo León Mexico 66460
    123 EME RED Hospitalaria Mérida Yucatán Mexico 97000
    124 Köhler & Milstein Research Mérida Yucatán Mexico 97070
    125 Centro de Atención e Investigación Clínica Aguascalientes Mexico 20119
    126 Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos Chihuahua Mexico 31110
    127 Arké SMO S.A de C.V Veracruz Mexico 91910
    128 INTERCOR Bydgoszcz Kujawsko-pomorskie Poland 85-605
    129 CenterMed Lublin NZOZ Lublin Lubelskie Poland 20-044
    130 Gabinety TERPA Lublin Lubelskie Poland 20-333
    131 MICS Centrum Medyczne Warszawa Warszawa Mazowieckie Poland 00-874
    132 Centrum Zdrowia Tuchów Wierzchosławice Małopolskie Poland 33-122
    133 Uniwersytecki Szpital Kliniczny w Białymstoku Białystok Podlaskie Poland 15-274
    134 Centrum Badan Klinicznych PI-House sp. z o.o. Gdansk Pomorskie Poland 80-546
    135 Centrum Kliniczno-Badawcze Elblag Warmińsko-mazurskie Poland 82-300
    136 Ambulatorium Sp. z o.o. Elbląg Warmińsko-mazurskie Poland 82-300
    137 Centrum Zdrowia Metabolicznego Pawel Bogdanski Poznań Wielkopolskie Poland 60-589
    138 NZOZ Salvia CM Katowice Śląskie Poland 40-772
    139 Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci Kielce Świętokrzyskie Poland 25-355
    140 Ponce Medical School Foundation Inc. Ponce Puerto Rico 00716
    141 Diabdana Oradea Bihor Romania 410147
    142 C.M.D.T.A. Neomed Brasov Brașov Romania 500283
    143 Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului Bucharest București Romania 011053
    144 Gama Diamed Mangalia Constanța Romania 905500
    145 Cabinet Medical Dr.Geru Timisoara Timiș Romania 300288
    146 SC Minimed SRL Bacău Romania 600238
    147 Diamed Obesity Galați Romania 800291
    148 Centrul Medical Consultmed Iași Romania 700547
    149 Clinica Korall Satu Mare Romania 440055
    150 Policlinica Astra Sibiu Sibiu Romania 550371
    151 CHUAC-Complejo Hospitalario Universitario A Coruña A Coruña A Coruña [La Coruña] Spain 15006
    152 Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval Ferrol A Coruña [La Coruña] Spain 15405
    153 Hospital Universitari Vall d'Hebron Barcelona Barcelona [Barcelona] Spain 08035
    154 Hospital Universitario Marqués de Valdecilla Santander Cantabria Spain 39008
    155 Hospital General Universitario de Valencia Valencia Valenciana, Comunitat Spain 46014
    156 Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) Sevilla Spain 41003
    157 Changhua Christian Hospital Changhua Taiwan 50006
    158 Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung Taiwan 807
    159 China Medical University Hospital Taichung Taiwan 404332
    160 National Cheng Kung University Hospital Tainan Taiwan 704
    161 Rowden Surgery Chippenham England United Kingdom SN15 2SB
    162 Layton Medical Centre Blackpool Lancashire United Kingdom FY3 7EN
    163 Leicester General Hospital Leicester Leicestershire United Kingdom LE5 4PW
    164 Panthera Biopartners - North London Enfield Town London, City Of United Kingdom EN3 4GS
    165 Glasgow Royal Infirmary Glasgow Scotland United Kingdom G31 2ER
    166 Heartlands Hospital Birmingham United Kingdom B9 5SS
    167 Aintree University Hospital NHS Foundation Trust Liverpool United Kingdom L9 7AL
    168 St Clare Medical Centre Penzance United Kingdom TR18 3DX
    169 Panthera Biopartners - Sheffield Sheffield United Kingdom S2 5FX

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559 or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05929066
    Other Study ID Numbers:
    • 18557
    • J1I-MC-GZBJ
    • J1I-MC-GOA1
    • J1I-MC-GSA1
    • 2023-503657-35-00
    First Posted:
    Jul 3, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Sleep Apnea, Obstructive
    Obesity
    Overweight

    Study Results

    No Results Posted as of Jul 11, 2023