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NCT05929079CompletedPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1152 (actual)
First submitted
26 Jun 2023
Start date
11 Jul 2023
Primary completion date
16 Jun 2026
Lead sponsor
Eli Lilly and Company
NCT number
NCT05929079
EU CT number
2023-503658-11-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1152
  • From 11 Jul 2023 to the primary completion date, 16 Jun 2026
  • 99 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • Have Type 1 diabetes
  • Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)

Other

  • Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days.
  • Have had pancreatitis
    • GSA2 Exclusion Criteria

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (99)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Centro Médico Viamonte
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Buenos AiresArgentinaUnknown status
Consultorio de Investigación Clínica EMO SRL
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Buenos AiresArgentinaUnknown status
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
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Buenos AiresArgentinaUnknown status
Centro de Salud e Investigaciones Médicas
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Santa RosaArgentinaUnknown status
Nightingale Research
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AdelaideAustraliaUnknown status
Flinders University
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Bedford ParkAustraliaUnknown status
Emeritus Research
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BotanyAustraliaUnknown status
Box Hill Hospital
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Box HillAustraliaUnknown status
Royal Brisbane and Women's Hospital
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BrisbaneAustraliaUnknown status
Core Research Group
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BrisbaneAustraliaUnknown status
Emeritus Research
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CamberwellAustraliaUnknown status
Austin Health - Repatriation Hospital
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Heidelberg WestAustraliaUnknown status
Advara HeartCare Joondalup
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JoondalupAustraliaUnknown status
Woolcock Institute of Medical Research
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Macquarie ParkAustraliaUnknown status
The AIM Centre / Hunter Diabetes Centre
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MerewetherAustraliaUnknown status
Southern Adelaide Diabetes & Endocrine Services
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Oaklands ParkAustraliaUnknown status
BR Trials-Ensaios Clinicos e Consultoria
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São PauloBrazilUnknown status
CPQuali Pesquisa Clínica
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São PauloBrazilUnknown status
CEPIC - Centro Paulista de Investigação Clínica
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São PauloBrazilUnknown status
Hospital Universitario Principe de Asturias
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Alcalá de HenaresSpainCompleted
Hospital Universitario Torrecárdenas
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AlmeríaSpainCompleted
Hospital Nisa Sevilla Aljarafe
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Castilleja De La CuestaSpainCompleted
Leon University Hospital
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LeonSpainCompleted
Hospital Universitario Ramón y Cajal
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MadridSpainCompleted
Hospital Universitario Regional de Málaga
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MálagaSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Zydus Hospitals & Healthcare Research Pvt. Ltd.
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AhmedabadIndiaUnknown status
Avron Hospitals
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AhmedabadIndiaUnknown status
V.S. General Hospital
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AhmedabadIndiaUnknown status
Life Care Hospital and Research Centre
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BangaloreIndiaUnknown status
Madras Diabetes Research Foundation
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ChennaiIndiaUnknown status
Sushruta Multispeciality Hospital & Research Centre
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HubliIndiaUnknown status
Care Hospitals Hyderabad- Banjara Hills
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HyderabadIndiaUnknown status
Diabetes Research Center
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HyderabadIndiaUnknown status
CARE CHL-Hospitals
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IndoreIndiaUnknown status
Sawai Man Singh Medical College Hospital (SMS Hospital)
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JaipurIndiaUnknown status
Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
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KolkataIndiaUnknown status
Mysore Medical College
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MysoreIndiaUnknown status
All India Institute of Medical Sciences
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RaipurIndiaUnknown status
Christian Medical College Vellore
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VelloreIndiaUnknown status
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
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Chihuahua CityMexicoUnknown status
Unidad de Investigación Clinica y atencion Medica HEPA
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GuadalajaraMexicoUnknown status
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
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GuadalajaraMexicoUnknown status
Diseno y Planeacion en Investigacion Medica
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GuadalajaraMexicoUnknown status
Centro de Investigacion en Artritis y Osteoporosis SC
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MexicaliMexicoUnknown status
Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares
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Mexico CityMexicoUnknown status
Clinica Omega
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Mexico CityMexicoUnknown status
RM Pharma Specialists
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Mexico CityMexicoUnknown status
Unidad Biomedica Avanzada Monterrey
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MonterreyMexicoUnknown status
Cardiolink Clin Trials
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MonterreyMexicoUnknown status
FAICIC S. de R.L. de C.V.
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VeracruzMexicoUnknown status
Arké SMO S.A de C.V
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VeracruzMexicoUnknown status
Sc Cmi Dr. Pletea Noemi S.R.L.
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BacauRomaniaCompleted
Easydiet S.R.L.
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BucharestRomaniaCompleted
Nutrilife S.R.L.
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BucharestRomaniaCompleted
Gama Diamed S.R.L.
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MangaliaRomaniaCompleted
Diabdana S.R.L.
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OradeaRomaniaCompleted
Mediab S.R.L.
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Târgu MureşRomaniaCompleted
Pinnacle Research Group, LLC
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AnnistonUnited StatesUnknown status
NeuroTrials Research Inc
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AtlantaUnited StatesUnknown status
FutureSearch Trials of Neurology
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AustinUnited StatesUnknown status
Northwest Clinical Research Center
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BellevueUnited StatesUnknown status
Excel Medical Clinical Trials
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Boca RatonUnited StatesUnknown status
Teradan Clinical trials LLC
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BrandonUnited StatesUnknown status
Core Healthcare Group
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CerritosUnited StatesUnknown status
Intrepid Research
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CincinnatiUnited StatesUnknown status
CTI Clinical Research Center
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CincinnatiUnited StatesUnknown status
StudyMetrix Research
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City of Saint PetersUnited StatesUnknown status
Cullman Clinical Trials
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CullmanUnited StatesUnknown status
Velocity Clinical Research, Dallas
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DallasUnited StatesUnknown status
Lillestol Research
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FargoUnited StatesUnknown status
Fleming Island Center for Clinical Research
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Fleming IslandUnited StatesUnknown status
Therafirst Medical Center
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Fort LauderdaleUnited StatesUnknown status
Tribe Clinical Research LLC
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GreenvilleUnited StatesUnknown status
East-West Medical Research Institute
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HonoluluUnited StatesUnknown status
Brengle Family Medicine
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IndianapolisUnited StatesUnknown status
Las Vegas Medical Research
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Las VegasUnited StatesUnknown status
Preferred Research Partners
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Little RockUnited StatesUnknown status
Velocity Clinical Research, Westlake
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Los AngelesUnited StatesUnknown status
Clinical Site Partners LLC, dba Flourish Research
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MiamiUnited StatesUnknown status
Quantum Clinical Trials
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Miami BeachUnited StatesUnknown status
Monroe Biomedical Research
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MonroeUnited StatesUnknown status
Carteret Medical Group
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Morehead CityUnited StatesUnknown status
Trial Management Associates
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Myrtle BeachUnited StatesUnknown status
Mid Hudson Medical Research
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New WindsorUnited StatesUnknown status
Valley Clinical Trials, Inc.
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NorthridgeUnited StatesUnknown status
Renstar Medical Research
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OcalaUnited StatesUnknown status
Advanced Research Institute
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OgdenUnited StatesUnknown status
Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)
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PittsburghUnited StatesUnknown status
Clinical Research Center of Florida
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Pompano BeachUnited StatesUnknown status
Centricity Research Rincon Pulmonology
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RinconUnited StatesUnknown status
Tribe Clinical Research - Spartanburg
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SpartanburgUnited StatesUnknown status
Preferred Primary Care Physicians
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UniontownUnited StatesUnknown status
Diablo Clinical Research, Inc.
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Walnut CreekUnited StatesUnknown status
MedVadis Research Corporation
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WalthamUnited StatesUnknown status
Chase Medical Research, LLC
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WaterburyUnited StatesUnknown status
Palm Beach Research Center
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West Palm BeachUnited StatesUnknown status
Clinical Site Partners, LLC dba Flourish Research
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Winter ParkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.