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

April 7, 2026 updated by: Eli Lilly and Company

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1120AAC
        • Centro Médico Viamonte
      • Buenos Aires, Buenos Aires F.D., Argentina, C1425AGC
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
      • Buenos Aires, Buenos Aires F.D., Argentina, 1405
        • Consultorio de Investigacion Clinica EMO SRL
    • La Pampa Province
      • Santa Rosa, La Pampa Province, Argentina, 6300
        • Centro de Salud e Investigaciones Médicas
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research
      • Macquarie Park, New South Wales, Australia, 2113
        • Woolcock Institute of Medical Research
      • Merewether, New South Wales, Australia, 2291
        • The AIM Centre / Hunter Diabetes Centre
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Brisbane, Queensland, Australia, 4064
        • Core Research Group
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Nightingale Research
      • Bedford Park, South Australia, Australia, 5042
        • Flinders University
      • Oaklands Park, South Australia, Australia, 5046
        • Southern Adelaide Diabetes & Endocrine Services
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
      • Heidelberg West, Victoria, Australia, 3081
        • Austin Health - Repatriation Hospital
    • Western Australia
      • Joondalup, Western Australia, Australia, 6027
        • Advara HeartCare Joondalup
  • Brazil
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica
      • São Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigação Clínica
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01236030
        • BR Trials - Ensaios Clinicos e Consultoria
  • India
    • Chhattisgarh
      • Raipur, Chhattisgarh, India, 492099
        • All India Institute of Medical Sciences
    • Gujarat
      • Ahmedabad, Gujarat, India, 380006
        • V.S. General Hospital
      • Ahmedabad, Gujarat, India, 380013
        • Avron Hospitals
      • Ahmedabad, Gujarat, India, 380054
        • Zydus Hospitals & Healthcare Research Pvt.Ltd.
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Life Care Hospital and Research Centre
      • Hubli, Karnataka, India, 580021
        • Sushruta Multispeciality Hospital & Research Centre
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452008
        • CARE CHL-Hospitals
    • Rajasthan
      • Jaipur, Rajasthan, India, 302004
        • Sawai Man Singh Medical College Hospital (SMS Hospital)
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Madras Diabetes Research Foundation
      • Vellore, Tamil Nadu, India, 632004
        • Christian Medical College Vellore
    • Telangana
      • Hyderabad, Telangana, India, 500034
        • Care Hospitals Hyderabad- Banjara Hills
      • Hyderabad, Telangana, India, 500082
        • Diabetes Research Center
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
  • Mexico
      • Chihuahua City, Mexico, 31110
        • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
      • Veracruz, Mexico, 91900
        • FAICIC S. de R.L. de C.V.
      • Veracruz, Mexico, 91910
        • Arké SMO S.A de C.V
    • Estado de Baja California
      • Mexicali, Estado de Baja California, Mexico, 21200
        • Centro de Investigacion en Artritis y Osteoporosis SC
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44130
        • Diseno y Planeacion en Investigacion Medica
      • Guadalajara, Jalisco, Mexico, 44670
        • Unidad de Investigación Clínica y Atención Médica HEPA
      • Guadalajara, Jalisco, Mexico, 44670
        • Private Practice - Dr. Arechavaleta Granell Maria del Rosario
    • Mexico City
      • Mexico City, Mexico City, Mexico, 11650
        • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
      • Mexico City, Mexico City, Mexico, 03100
        • RM Pharma Specialists
      • Mexico City, Mexico City, Mexico, 06700
        • Clinica Omega
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Unidad Biomedica Avanzada Monterrey
      • Monterrey, Nuevo León, Mexico, 64060
        • Cardiolink Clin Trials
  • Romania
      • Bacau, Romania, 600154
        • CMI Dr.Pletea Noemi SRL
    • Bihor County
      • Oradea, Bihor County, Romania, 410147
        • Diabdana
    • București
      • Bucharest, București, Romania, 010627
        • Geea Medical Easy Diet
      • Bucharest, București, Romania, 013764
        • Centrul Medical NutriLife
    • Constanța County
      • Mangalia, Constanța County, Romania, 905500
        • Gama Diamed
    • Mureș County
      • Târgu Mureş, Mureș County, Romania, 540142
        • Centrul Medical Mediab
  • Spain
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocío
    • Almería
      • Almería, Almería, Spain, 04009
        • Centro Periférico de Especialidades Bola Azul
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Málaga, Andalusia, Spain, 29009
        • H.R.U Málaga - Hospital Civil
    • Castille and León
      • León, Castille and León, Spain, 24071
        • Complejo Asistencial Universitario de León - Hospital de León
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramón y Cajal
    • Sevilla
      • Seville, Sevilla, Spain, 41950
        • Vithas Hospital Sevilla
  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Pinnacle Research Group, LLC
      • Cullman, Alabama, United States, 35055
        • Cullman Clinical Trials
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners
    • California
      • Cerritos, California, United States, 90703
        • Core Healthcare Group
      • Los Angeles, California, United States, 90057
        • Velocity Clinical Research, Westlake
      • Northridge, California, United States, 91325
        • Valley Clinical Trials, Inc.
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research, Inc.
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
        • Chase Medical Research, LLC
    • Florida
      • Boca Raton, Florida, United States, 33434
        • Excel Medical Clinical Trials
      • Brandon, Florida, United States, 33511
        • Teradan Clinical Trials, LLC
      • Fleming Island, Florida, United States, 32003
        • Fleming Island Center for Clinical Research
      • Fort Lauderdale, Florida, United States, 33308
        • Therafirst Medical Center
      • Miami, Florida, United States, 33186
        • Clinical Site Partners LLC, dba Flourish Research
      • Miami Beach, Florida, United States, 33140
        • Quantum Clinical Trials
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Pompano Beach, Florida, United States, 33060
        • Clinical Research Center Of Florida
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners, LLC dba Flourish Research
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • NeuroTrials Research Inc
      • Rincon, Georgia, United States, 31406
        • Centricity Research Rincon Pulmonology
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Brengle Family Medicine
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • MedVadis Research Corporation
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Medical Research
    • New York
      • New Windsor, New York, United States, 12553
        • Mid Hudson Medical Research
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Monroe Biomedical Research
      • Morehead City, North Carolina, United States, 28557
        • Carteret Medical Group
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • CTI Clinical Research Center
      • Cincinnati, Ohio, United States, 45245
        • Intrepid Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15236
        • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
      • Uniontown, Pennsylvania, United States, 15401
        • Preferred Primary Care Physicians
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Tribe Clinical Research, LLC
      • Myrtle Beach, South Carolina, United States, 29572
        • Trial Management Associates
      • Spartanburg, South Carolina, United States, 29301
        • Tribe Clinical Research - Spartanburg
    • Texas
      • Austin, Texas, United States, 78731
        • FutureSearch Trials of Neurology
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
    • Utah
      • Ogden, Utah, United States, 84405
        • Advanced Research Institute
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo.
Drug: Placebo
Administered SC
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent Change from Baseline in Body Weight
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Time Frame: Baseline, Week 80
Baseline, Week 80

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Body Mass Index (BMI)
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Waist Circumference
Time Frame: Baseline, Week 80
Baseline, Week 80
Percent Change from Baseline in Total Cholesterol
Time Frame: Baseline, Week 80
Baseline, Week 80
Percent Change from Baseline in Triglycerides
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Hemoglobin (A1c) HbA1c %
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Time Frame: Baseline, Week 80
Baseline, Week 80
Change from Baseline in Fasting Glucose
Time Frame: Baseline, Week 80
Baseline, Week 80
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)
Time Frame: Baseline through Week 80
AUC is presented as a single average measure of AUC across the study duration.
Baseline through Week 80
Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset
Time Frame: Baseline, Week 80
Baseline, Week 80
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
Time Frame: 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.
Baseline to Week 80
Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset
Time Frame: Baseline to Week 80
Baseline to Week 80
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) ≤10 for GSA2 Subset
Time Frame: Week 80
Week 80

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2023

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 26, 2023

First Submitted That Met QC Criteria

June 26, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18558
  • J1I-MC-GZBK (Other Identifier: Master Protocol Eli Lilly and Company)
  • J1I-MC-GSA2 (Other Identifier: ISA Eli Lilly and Company)
  • 2023-503658-11-00 (Other Identifier: EU Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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