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Type 2 DiabetesPhase 3TRIUMPH-2NCT05929079

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

A Phase 3 study testing Retatrutide in people with Type 2 Diabetes and Obesity, run by Eli Lilly and Company at 98 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes, Obesity, Overweight
What is being tested?
Retatrutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,152 participants
Where
98 sitesin 8 countries
Study dates
11 Jul 2023to 16 Jun 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

98 sites in 8 countries.

98 sites in 8 countries

United States40 sites

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207

  • NeuroTrials Research Inc

    Atlanta, Georgia, 30328

  • FutureSearch Trials of Neurology

    Austin, Texas, 78731

  • Northwest Clinical Research Center

    Bellevue, Washington, 98007

  • Excel Medical Clinical Trials

    Boca Raton, Florida, 33434

  • Teradan Clinical Trials, LLC

    Brandon, Florida, 33511

  • Core Healthcare Group

    Cerritos, California, 90703

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Intrepid Research

    Cincinnati, Ohio, 45245

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Cullman Clinical Trials

    Cullman, Alabama, 35055

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Lillestol Research

    Fargo, North Dakota, 58104

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • Therafirst Medical Center

    Fort Lauderdale, Florida, 33308

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Brengle Family Medicine

    Indianapolis, Indiana, 46260

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128

  • Preferred Research Partners

    Little Rock, Arkansas, 72211

  • Velocity Clinical Research, Westlake

    Los Angeles, California, 90057

  • Clinical Site Partners LLC, dba Flourish Research

    Miami, Florida, 33186

  • Quantum Clinical Trials

    Miami Beach, Florida, 33140

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Carteret Medical Group

    Morehead City, North Carolina, 28557

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572

  • Mid Hudson Medical Research

    New Windsor, New York, 12553

  • Valley Clinical Trials, Inc.

    Northridge, California, 91325

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Advanced Research Institute

    Ogden, Utah, 84405

  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

    Pittsburgh, Pennsylvania, 15236

  • Clinical Research Center of Florida

    Pompano Beach, Florida, 33060

  • Centricity Research Rincon Pulmonology

    Rincon, Georgia, 31406

  • Tribe Clinical Research - Spartanburg

    Spartanburg, South Carolina, 29301

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • MedVadis Research Corporation

    Waltham, Massachusetts, 02451

  • Chase Medical Research, LLC

    Waterbury, Connecticut, 06708

  • Palm Beach Research Center

    West Palm Beach, Florida, 33409

  • Clinical Site Partners, LLC dba Flourish Research

    Winter Park, Florida, 32789

Other trials in United States

India14 sites

  • V.S. General Hospital

    Ahmedabad, Gujarat, 380006

  • Avron Hospitals

    Ahmedabad, Gujarat, 380013

  • Zydus Hospitals & Healthcare Research Pvt.Ltd.

    Ahmedabad, Gujarat, 380054

  • Life Care Hospital and Research Centre

    Bangalore, Karnataka, 560092

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • Sushruta Multispeciality Hospital & Research Centre

    Hubli, Karnataka, 580021

  • Care Hospitals Hyderabad- Banjara Hills

    Hyderabad, Telangana, 500034

  • Diabetes Research Center

    Hyderabad, Telangana, 500082

  • CARE CHL-Hospitals

    Indore, Madhya Pradesh, 452008

  • Sawai Man Singh Medical College Hospital (SMS Hospital)

    Jaipur, Rajasthan, 302004

  • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

    Kolkata, West Bengal, 700020

  • Mysore Medical College

    Mysore, Karnataka, 570001

  • All India Institute of Medical Sciences

    Raipur, Chhattisgarh, 492099

  • Christian Medical College Vellore

    Vellore, Tamil Nadu, 632004

Other trials in India

Australia12 sites

  • Nightingale Research

    Adelaide, South Australia, 5000

  • Flinders University

    Bedford Park, South Australia, 5042

  • Emeritus Research

    Botany, New South Wales, 2019

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Core Research Group

    Brisbane, Queensland, 4064

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Austin Health - Repatriation Hospital

    Heidelberg West, Victoria, 3081

  • Advara HeartCare Joondalup

    Joondalup, Western Australia, 6027

  • Woolcock Institute of Medical Research

    Macquarie Park, New South Wales, 2113

  • The AIM Centre / Hunter Diabetes Centre

    Merewether, New South Wales, 2291

  • Southern Adelaide Diabetes & Endocrine Services

    Oaklands Park, South Australia, 5046

Other trials in Australia

Mexico12 sites

  • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

    Chihuahua City, Chihuahua, 31110

  • Diseno y Planeacion en Investigacion Medica

    Guadalajara, Jalisco, 44130

  • Private Practice - Dr. Arechavaleta Granell Maria del Rosario

    Guadalajara, Jalisco, 44670

  • Unidad de Investigación Clínica y Atención Médica HEPA

    Guadalajara, Jalisco, 44670

  • Centro de Investigacion en Artritis y Osteoporosis SC

    Mexicali, Estado de Baja California, 21200

  • RM Pharma Specialists

    Mexico City, Mexico City, 03100

  • Clinica Omega

    Mexico City, Mexico City, 06700

  • Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares

    Mexico City, Mexico City, 11650

  • Cardiolink Clin Trials

    Monterrey, Nuevo León, 64060

  • Unidad biomedica avanzada monterrey

    Monterrey, Nuevo León, 64460

  • FAICIC S. de R.L. de C.V.

    Veracruz, Veracruz, 91900

  • Arké SMO S.A de C.V

    Veracruz, Veracruz, 91910

Other trials in Mexico

Spain7 sites

  • Centro Periférico de Especialidades Bola Azul

    Almería, Almería, 04009

  • Complejo Asistencial Universitario de León - Hospital de León

    León, Castille and León, 24071

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

  • H.R.U Málaga - Hospital Civil

    Málaga, Andalusia, 29009

  • Hospital Universitario Virgen de la Victoria

    Málaga, Andalusia, 29010

  • Hospital Universitario Virgen Del Rocio

    Seville, Sevilla, 41013

  • Vithas Hospital Sevilla

    Seville, Sevilla, 41950

Other trials in Spain

Romania6 sites

  • CMI Dr.Pletea Noemi SRL

    Bacau, Bacău, 600154

  • Geea Medical Easy Diet

    Bucharest, Bucharest, 010627

  • Centrul Medical NutriLife

    Bucharest, Bucharest, 013764

  • Gama Diamed

    Mangalia, Constanța County, 905500

  • Diabdana

    Oradea, Bihor County, 410147

  • Centrul Medical Mediab

    Târgu Mureş, Mureș County, 540142

Other trials in Romania

Argentina4 sites

  • Consultorio de Investigación Clínica EMO SRL

    Buenos Aires, Buenos Aires F.D., 1405

  • Centro Médico Viamonte

    Buenos Aires, Buenos Aires F.D., C1120AAC

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, Buenos Aires F.D., C1425AGC

  • Centro de Salud e Investigaciones Médicas

    Santa Rosa, La Pampa Province, 6300

Other trials in Argentina

Brazil3 sites

  • CPQuali Pesquisa Clínica

    São Paulo, São Paulo, 01228-000

  • BR Trials - Ensaios Clinicos e Consultoria

    São Paulo, São Paulo, 01236030

  • CEPIC - Centro Paulista de Investigação Clínica

    São Paulo, São Paulo, 04266-010

Other trials in Brazil

About this study

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

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.

Being tested
Retatrutide, Placebo
Medical subject headings
Diabetes Mellitus, Type 2, Obesity, Overweight, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RetatrutideDrug

    Also called LY3437943

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT05929079
Study groupRoleWhat they receive
Retatrutide Dose 1ExperimentalParticipants will receive retatrutide subcutaneously (SC).
Receives: Drug: Retatrutide
Retatrutide Dose 2ExperimentalParticipants will receive retatrutide SC.
Receives: Drug: Retatrutide
Retatrutide Dose 3ExperimentalParticipants will receive retatrutide SC.
Receives: Drug: Retatrutide
PlaceboPlacebo comparatorParticipants will receive placebo.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 80

  2. Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset

    Measured: Baseline, Week 80

Secondary outcomes (14)

  1. Change from Baseline in Body Mass Index (BMI)

    Measured: Baseline, Week 80

  2. Change from Baseline in Waist Circumference

    Measured: Baseline, Week 80

  3. Change from Baseline in Systolic Blood Pressure (SBP)

    Measured: Baseline, Week 80

  4. Change from Baseline in Diastolic Blood Pressure (DBP)

    Measured: Baseline, Week 80

  5. Percent Change from Baseline in Total Cholesterol

    Measured: Baseline, Week 80

  6. Percent Change from Baseline in Triglycerides

    Measured: Baseline, Week 80

  7. Change from Baseline in Hemoglobin (A1c) HbA1c %

    Measured: Baseline, Week 80

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

    Measured: Baseline, Week 80

  9. Change from Baseline in Fasting Glucose

    Measured: Baseline, Week 80

  10. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)

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

    Measured: Baseline through Week 80

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

    Measured: 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

    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.

    Measured: Baseline to Week 80

  13. Percentage of Participants with ≥50% AHI Reduction from Baseline for GSA2 Subset

    Measured: 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

    Measured: Week 80

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2023
  2. Study start11 Jul 2023
  3. Primary completion16 Jun 2026
  4. Study completion16 Jun 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05929079
Sponsor's protocol ID
18558
Other IDs
J1I-MC-GZBK, J1I-MC-GSA2, 2023-503658-11-00, 2023
Acronym
TRIUMPH-2
Status last verified
Jul 2026
First submitted
26 Jun 2023
Last updated
30 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Grunstein RR, Somers VK, Azarbarzin A, Malhotra A, Sands SA, Lucey BP, Allen SE, Giblin K, Falcon BL, Park SY, Lou J, Krueger K; TRIUMPH-1-OSA and TRIUMPH-2-OSA Investigators. Retatrutide Once Weekly for Treatment of Obstructive Sleep Apnea. N Engl J Med. 2026 Oct 21. doi: 10.1056/NEJMoa2611477. Online ahead of print.

    PubMed 42904878

  • Bellido V, le Roux CW, Ekinci EI, Bjornstad P, Frias JP, Giblin K, Eyde S, Park SY, Ferro J, Johnson C, Taylor A. Retatrutide in adults with obesity and type 2 diabetes (TRIUMPH-2): a double-blind, parallel-group, randomised, placebo-controlled, phase 3 trial. Lancet. 2026 Sep 29:S0140-6736(26)01861-1. doi: 10.1016/S0140-6736(26)01861-1. Online ahead of print.

    PubMed 42810372

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Retatrutide in people with Type 2 Diabetes and Obesity, run by Eli Lilly and Company at 98 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 98 sites in United States, India, Australia, Mexico, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in Body Weight (time frame: Baseline, Week 80). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05929079, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.

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