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
- Diseases
- Obesity, Type 2 diabetes
- 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
Sites (99)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro Médico Viamonte Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Consultorio de Investigación Clínica EMO SRL Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Centro de Salud e Investigaciones Médicas Coordinator of this site? Confirm its status | Santa Rosa | Argentina | Unknown status |
| Nightingale Research Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Flinders University Coordinator of this site? Confirm its status | Bedford Park | Australia | Unknown status |
| Emeritus Research Coordinator of this site? Confirm its status | Botany | Australia | Unknown status |
| Box Hill Hospital Coordinator of this site? Confirm its status | Box Hill | Australia | Unknown status |
| Royal Brisbane and Women's Hospital Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Core Research Group Coordinator of this site? Confirm its status | Brisbane | Australia | Unknown status |
| Emeritus Research Coordinator of this site? Confirm its status | Camberwell | Australia | Unknown status |
| Austin Health - Repatriation Hospital Coordinator of this site? Confirm its status | Heidelberg West | Australia | Unknown status |
| Advara HeartCare Joondalup Coordinator of this site? Confirm its status | Joondalup | Australia | Unknown status |
| Woolcock Institute of Medical Research Coordinator of this site? Confirm its status | Macquarie Park | Australia | Unknown status |
| The AIM Centre / Hunter Diabetes Centre Coordinator of this site? Confirm its status | Merewether | Australia | Unknown status |
| Southern Adelaide Diabetes & Endocrine Services Coordinator of this site? Confirm its status | Oaklands Park | Australia | Unknown status |
| BR Trials-Ensaios Clinicos e Consultoria Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CPQuali Pesquisa Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| CEPIC - Centro Paulista de Investigação Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Universitario Principe de Asturias Coordinator of this site? Confirm its status | Alcalá de Henares | Spain | Completed |
| Hospital Universitario Torrecárdenas Coordinator of this site? Confirm its status | Almería | Spain | Completed |
| Hospital Nisa Sevilla Aljarafe Coordinator of this site? Confirm its status | Castilleja De La Cuesta | Spain | Completed |
| Leon University Hospital Coordinator of this site? Confirm its status | Leon | Spain | Completed |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| Hospital Universitario Virgen de la Victoria Coordinator of this site? Confirm its status | Málaga | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Zydus Hospitals & Healthcare Research Pvt. Ltd. Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Avron Hospitals Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| V.S. General Hospital Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| Life Care Hospital and Research Centre Coordinator of this site? Confirm its status | Bangalore | India | Unknown status |
| Madras Diabetes Research Foundation Coordinator of this site? Confirm its status | Chennai | India | Unknown status |
| Sushruta Multispeciality Hospital & Research Centre Coordinator of this site? Confirm its status | Hubli | India | Unknown status |
| Care Hospitals Hyderabad- Banjara Hills Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| Diabetes Research Center Coordinator of this site? Confirm its status | Hyderabad | India | Unknown status |
| CARE CHL-Hospitals Coordinator of this site? Confirm its status | Indore | India | Unknown status |
| Sawai Man Singh Medical College Hospital (SMS Hospital) Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Mysore Medical College Coordinator of this site? Confirm its status | Mysore | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Raipur | India | Unknown status |
| Christian Medical College Vellore Coordinator of this site? Confirm its status | Vellore | India | Unknown status |
| Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Unidad de Investigación Clinica y atencion Medica HEPA Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Private Practice - Dr. Arechavaleta Granell Maria del Rosario Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Diseno y Planeacion en Investigacion Medica Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Centro de Investigacion en Artritis y Osteoporosis SC Coordinator of this site? Confirm its status | Mexicali | Mexico | Unknown status |
| Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Clinica Omega Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| RM Pharma Specialists Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Unidad Biomedica Avanzada Monterrey Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
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| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Sc Cmi Dr. Pletea Noemi S.R.L. Coordinator of this site? Confirm its status | Bacau | Romania | Completed |
| Easydiet S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Nutrilife S.R.L. Coordinator of this site? Confirm its status | Bucharest | Romania | Completed |
| Gama Diamed S.R.L. Coordinator of this site? Confirm its status | Mangalia | Romania | Completed |
| Diabdana S.R.L. Coordinator of this site? Confirm its status | Oradea | Romania | Completed |
| Mediab S.R.L. Coordinator of this site? Confirm its status | Târgu Mureş | Romania | Completed |
| Pinnacle Research Group, LLC Coordinator of this site? Confirm its status | Anniston | United States | Unknown status |
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| Velocity Clinical Research, Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
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This page is information, not medical advice. Discuss any trial with your doctor.