A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
TRIUMPH-2
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
4 other identifiers
interventional
1,000
8 countries
98
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes
Started Jul 2023
Longer than P75 for phase_3 type-2-diabetes
98 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedApril 13, 2026
April 1, 2026
2.8 years
June 26, 2023
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Percent Change from Baseline in Body Weight
Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Baseline, Week 80
Secondary Outcomes (14)
Change from Baseline in Body Mass Index (BMI)
Baseline, Week 80
Change from Baseline in Waist Circumference
Baseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Baseline, Week 80
Change from Baseline in Diastolic Blood Pressure (DBP)
Baseline, Week 80
Percent Change from Baseline in Total Cholesterol
Baseline, Week 80
- +9 more secondary outcomes
Study Arms (4)
Retatrutide Dose 1
EXPERIMENTALParticipants will receive retatrutide subcutaneously (SC).
Retatrutide Dose 2
EXPERIMENTALParticipants will receive retatrutide SC.
Retatrutide Dose 3
EXPERIMENTALParticipants will receive retatrutide SC.
Placebo
PLACEBO COMPARATORParticipants will receive placebo.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (98)
Pinnacle Research Group, LLC
Anniston, Alabama, 36207, United States
Cullman Clinical Trials
Cullman, Alabama, 35055, United States
Preferred Research Partners
Little Rock, Arkansas, 72211, United States
Core Healthcare Group
Cerritos, California, 90703, United States
Velocity Clinical Research, Westlake
Los Angeles, California, 90057, United States
Valley Clinical Trials, Inc.
Northridge, California, 91325, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Excel Medical Clinical Trials
Boca Raton, Florida, 33434, United States
Teradan Clinical Trials, LLC
Brandon, Florida, 33511, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003, United States
Therafirst Medical Center
Fort Lauderdale, Florida, 33308, United States
Clinical Site Partners LLC, dba Flourish Research
Miami, Florida, 33186, United States
Quantum Clinical Trials
Miami Beach, Florida, 33140, United States
Renstar Medical Research
Ocala, Florida, 34470, United States
Clinical Research Center of Florida
Pompano Beach, Florida, 33060, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789, United States
NeuroTrials Research Inc
Atlanta, Georgia, 30328, United States
Centricity Research Rincon Pulmonology
Rincon, Georgia, 31406, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Brengle Family Medicine
Indianapolis, Indiana, 46260, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
Mid Hudson Medical Research
New Windsor, New York, 12553, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Intrepid Research
Cincinnati, Ohio, 45245, United States
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
Pittsburgh, Pennsylvania, 15236, United States
Preferred Primary Care Physicians
Uniontown, Pennsylvania, 15401, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Trial Management Associates
Myrtle Beach, South Carolina, 29572, United States
Tribe Clinical Research - Spartanburg
Spartanburg, South Carolina, 29301, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Consultorio de Investigación Clínica EMO SRL
Buenos Aires, Buenos Aires F.D., 1405, Argentina
Centro Médico Viamonte
Buenos Aires, Buenos Aires F.D., C1120AAC, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Buenos Aires F.D., C1425AGC, Argentina
Centro de Salud e Investigaciones Médicas
Santa Rosa, La Pampa Province, 6300, Argentina
Emeritus Research
Botany, New South Wales, 2019, Australia
Woolcock Institute of Medical Research
Macquarie Park, New South Wales, 2113, Australia
The AIM Centre / Hunter Diabetes Centre
Merewether, New South Wales, 2291, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Core Research Group
Brisbane, Queensland, 4064, Australia
Nightingale Research
Adelaide, South Australia, 5000, Australia
Flinders University
Bedford Park, South Australia, 5042, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, 5046, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Austin Health - Repatriation Hospital
Heidelberg West, Victoria, 3081, Australia
Advara HeartCare Joondalup
Joondalup, Western Australia, 6027, Australia
BR Trials - Ensaios Clinicos e Consultoria
São Paulo, São Paulo, 01236030, Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010, Brazil
All India Institute of Medical Sciences
Raipur, Chhattisgarh, 492099, India
V.S. General Hospital
Ahmedabad, Gujarat, 380006, India
Avron Hospitals
Ahmedabad, Gujarat, 380013, India
Zydus Hospitals & Healthcare Research Pvt.Ltd.
Ahmedabad, Gujarat, 380054, India
Life Care Hospital and Research Centre
Bangalore, Karnataka, 560092, India
Sushruta Multispeciality Hospital & Research Centre
Hubli, Karnataka, 580021, India
Mysore Medical College
Mysore, Karnataka, 570001, India
CARE CHL-Hospitals
Indore, Madhya Pradesh, 452008, India
Sawai Man Singh Medical College Hospital (SMS Hospital)
Jaipur, Rajasthan, 302004, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086, India
Christian Medical College Vellore
Vellore, Tamil Nadu, 632004, India
Care Hospitals Hyderabad- Banjara Hills
Hyderabad, Telangana, 500034, India
Diabetes Research Center
Hyderabad, Telangana, 500082, India
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
Kolkata, West Bengal, 700020, India
Centro de Investigacion en Artritis y Osteoporosis SC
Mexicali, Estado de Baja California, 21200, Mexico
Diseno y Planeacion en Investigacion Medica
Guadalajara, Jalisco, 44130, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, 44670, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA
Guadalajara, Jalisco, 44670, Mexico
RM Pharma Specialists
Mexico City, Mexico City, 03100, Mexico
Clinica Omega
Mexico City, Mexico City, 06700, Mexico
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
Mexico City, Mexico City, 11650, Mexico
Cardiolink Clin Trials
Monterrey, Nuevo León, 64060, Mexico
Unidad biomedica avanzada monterrey
Monterrey, Nuevo León, 64460, Mexico
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
Chihuahua City, 31110, Mexico
FAICIC S. de R.L. de C.V.
Veracruz, 91900, Mexico
Arké SMO S.A de C.V
Veracruz, 91910, Mexico
Diabdana
Oradea, Bihor County, 410147, Romania
Geea Medical Easy Diet
Bucharest, București, 010627, Romania
Centrul Medical NutriLife
Bucharest, București, 013764, Romania
Gama Diamed
Mangalia, Constanța County, 905500, Romania
Centrul Medical Mediab
Târgu Mureş, Mureș County, 540142, Romania
CMI Dr.Pletea Noemi SRL
Bacau, 600154, Romania
Centro Periférico de Especialidades Bola Azul
Almería, Almería, 04009, Spain
H.R.U Málaga - Hospital Civil
Málaga, Andalusia, 29009, Spain
Hospital Universitario Virgen de la Victoria
Málaga, Andalusia, 29010, Spain
Complejo Asistencial Universitario de León - Hospital de León
León, Castille and León, 24071, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Comunidad de, 28034, Spain
Vithas Hospital Sevilla
Seville, Sevilla, 41950, Spain
Hospital Universitario Virgen Del Rocio
Seville, 41013, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- 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 Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2023
First Posted
July 3, 2023
Study Start
July 11, 2023
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- a are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.