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

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05929079
Collaborator
(none)
1,000
Enrollment
92
Locations
4
Arms
33.8
Anticipated Duration (Months)
10.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 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 With Type 2 Diabetes Mellitus Who Have Obesity or Overweight: A Randomized Double-Blind, Placebo-Controlled Trial
Anticipated Study Start Date :
Aug 7, 2023
Anticipated Primary Completion Date :
May 3, 2026
Anticipated Study Completion Date :
May 31, 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 Apnea-Hypopnea Index (AHI) for GSA2 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. Change from Baseline in Diastolic Blood Pressure (DBP) [Baseline, Week 80]

    5. Percent Change from Baseline in Total Cholesterol [Baseline, Week 80]

    6. Percent Change from Baseline in Triglycerides [Baseline, Week 80]

    7. Change from Baseline in Hemoglobin (A1c) HbA1c % [Baseline, Week 80]

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

    9. Change from Baseline in Fasting Glucose [Baseline, Week 80]

    10. 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.

    11. Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 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 GSA2 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 component.

    13. Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset [Baseline to Week 80]

    14. Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 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 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 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 Type 1 diabetes

    • Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine 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 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 Velocity Clinical Research, Westlake Los Angeles California United States 90057
    2 Valley Clinical Trials, Inc. Northridge California United States 91325
    3 Diablo Clinical Research, Inc. Walnut Creek California United States 94598
    4 Chase Medical Research, LLC Waterbury Connecticut United States 06708
    5 Teradan Clinical Trials, LLC Brandon Florida United States 33511
    6 Renstar Medical Research Ocala Florida United States 34470
    7 Palm Beach Research Center West Palm Beach Florida United States 33409
    8 NeuroTrials Research Inc Atlanta Georgia United States 30328
    9 East-West Medical Research Institute Honolulu Hawaii United States 96814
    10 Brengle Family Medicine Indianapolis Indiana United States 46260
    11 MedVadis Research Corporation Waltham Massachusetts United States 02451
    12 StudyMetrix Research Saint Peters Missouri United States 63303
    13 Las Vegas Medical Research Las Vegas Nevada United States 89113
    14 Carteret Medical Group Morehead City North Carolina United States 28557
    15 Lillestol Research Fargo North Dakota United States 58104
    16 CTI Clinical Research Center Cincinnati Ohio United States 45212
    17 Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18) Pittsburgh Pennsylvania United States 15236
    18 Tribe Clinical Research, LLC Greenville South Carolina United States 29607
    19 Trial Management Associates Myrtle Beach South Carolina United States 29572
    20 Tribe Clinical Research - Spartanburg Spartanburg South Carolina United States 29301
    21 FutureSearch Trials of Neurology Austin Texas United States 78731
    22 Velocity Clinical Research, Dallas Dallas Texas United States 75230
    23 Advanced Research Institute Ogden Utah United States 84405
    24 The AIM Centre / Hunter Diabetes Centre Merewether New South Wales Australia 2291
    25 Woolcock Institute of Medical Research Sydney New South Wales Australia 2037
    26 Royal Brisbane and Women's Hospital Brisbane Queensland Australia 4029
    27 Core Research Group Brisbane Queensland Australia 4064
    28 Nightingale Research Adelaide South Australia Australia 5000
    29 Southern Adelaide Diabetes & Endocrine Services Oaklands Park South Australia Australia 5046
    30 Flinders University Bedford Park South Aust Australia 5042
    31 Box Hill Hospital Box Hill Victoria Australia 3128
    32 Austin Health - Repatriation Hospital Heidelberg West Victoria Australia 3081
    33 Advara HeartCare Joondalup Joondalup Western Australia Australia 6027
    34 Beijing Hospital Beijing Beijing China 100730
    35 The Fourth Hospital of Harbin Medical University Harbin Heilongjiang China 150001
    36 The Second Affiliated Hospital of Zhengzhou University Zhengzhou Henan China 450014
    37 Baotou Central Hospital Baotou Inner Mongolia China 014040
    38 Nanjing First Hospital Nanjing Jiangsu China 210006
    39 The Second Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China 210011
    40 The First Hospital of Jilin University Changchun Jilin China 130021
    41 The First Affiliated Hospital of Xi'an Medical University Xi'an Shaanxi China 710077
    42 Pudong New Area People's Hospital Shanghai Shanghai Shanghai China 201200
    43 West China Hospital of Sichuan University Chengdu Sichuan China 610041
    44 Ningbo First Hospital Ningbo Zhejiang China 315010
    45 All India Institute of Medical Sciences Raipur Chhattisgarh India 492099
    46 V.S. General Hospital Ahmedabad Gujarat India 380006
    47 Avron Hospitals Ahmedabad Gujarat India 380013
    48 Zydus Hospitals & Healthcare Research Pvt.Ltd. Ahmedabad Gujarat India 380054
    49 Life Care Hospital and Research Centre Bangalore Karnataka India 560092
    50 Sushruta Multispeciality Hospital & Research Centre Hubli Karnataka India 580021
    51 Mysore Medical College Mysore Karnataka India 570001
    52 CARE CHL-Hospitals Indore Madhya Pradesh India 452008
    53 Sawai Man Singh Medical College Hospital (SMS Hospital) Jaipur Rajasthan India 302004
    54 Madras Diabetes Research Foundation Chennai Tamil Nadu India 600086
    55 Christian Medical College Vellore Vellore Tamil Nadu India 632004
    56 Care Hospitals Hyderabad- Banjara Hills Hyderabad Telangana India 500034
    57 Kumudini Devi Diabetes Research Center Hyderabad Telangana India 500072
    58 Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital Kolkata West Bengal India 700020
    59 Korea University Ansan Hospital Ansan-si Kyǒnggi-do Korea, Republic of 15355
    60 Hanyang University Guri Hospital Guri-si Kyǒnggi-do Korea, Republic of 11923
    61 Yeungnam Univeristy Medical Center Gyeongsan-si Kyǒngsangbuk-do Korea, Republic of 42415
    62 Severance Hospital, Yonsei University Health System Seoul Seoul-teuk Korea, Republic of 3722
    63 Seoul National University Hospital Seoul Seoul-teuk Korea, Republic of
    64 Ulsan University Hospital Ulsan Ulsan-Kwangyǒkshi Korea, Republic of 44033
    65 Centro de Investigacion en Artritis y Osteoporosis SC Mexicali Baja California Mexico 21200
    66 RM Pharma Specialists Mexico City Distrito Federal Mexico 03100
    67 Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Mexico City Distrito Federal Mexico 11650
    68 Diseno y Planeacion en Investigacion Medica Guadalajara Jalisco Mexico 44130
    69 Private Practice - Dr. Arechavaleta Granell Maria del Rosario Guadalajara Jalisco Mexico 44670
    70 Unidad de Investigación Clínica y Atención Médica HEPA Guadalajara Jalisco Mexico 44670
    71 Cardiolink Clin Trials Monterrey Nuevo León Mexico 64060
    72 Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos Chihuahua Mexico 31110
    73 FAICIC S. de R.L. de C.V. Veracruz Mexico 91900
    74 Arké SMO S.A de C.V Veracruz Mexico 91910
    75 Diabdana Oradea Bihor Romania 410147
    76 Geea Medical Easy Diet Bucharest București Romania 010627
    77 Centrul Medical NutriLife Bucharest București Romania 013761
    78 Gama Diamed Mangalia Constanța Romania 905500
    79 Centrul Medical Mediab Târgu-Mureș Mureș Romania 540142
    80 CMI Dr.Pletea Noemi SRL Bacău Romania 600154
    81 Centro Periférico de Especialidades Bola Azul Almeria Almería Spain 04009
    82 'Hospital Virgen de la Victoria Malaga Andalucía Spain 29010
    83 H.R.U Málaga - Hospital Civil Málaga Andalucía Spain 29009
    84 Complejo Asistencial Universitario de León - Hospital de León León Castilla Y León Spain 24071
    85 Hospital Universitario Principe de Asturias Alcalá de Henares Madrid, Comunidad De Spain 28805
    86 Hospital Universitario Ramón y Cajal Madrid Madrid, Comunidad De Spain 28034
    87 Vithas Hospital Sevilla Seville Sevilla Spain 41950
    88 Hospital Universitario Virgen Del Rocio Sevilla Spain 41013
    89 Chung Shan Medical University Hospital Taichung City Taichung Taiwan 402
    90 Chi Mei Medical Center Tainan City Tainan Taiwan 71004
    91 Taipei Veterans General Hospital Taipei City Taipei Taiwan 112
    92 Chang Gung Memorial Hospital at Kaohsiung Kaohsiung Taiwan 83301

    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:
    NCT05929079
    Other Study ID Numbers:
    • 18558
    • J1I-MC-GZBK
    • J1I-MC-GSA2
    • 2023-503658-11-00
    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
    Diabetes Mellitus
    Obesity
    Diabetes Mellitus, Type 2
    Overweight

    Study Results

    No Results Posted as of Jul 11, 2023