NCT05929066CompletedPhase 3
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial (TRIUMPH-1)
Source: ClinicalTrials.gov · Last updated 21 Aug 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of retatrutide in participants who have obesity or overweight (J1I-MC-GZBJ master protocol) including subsets of participants who have knee osteoarthritis (OA) (J1I-MC-GOA1) or who have obstructive sleep apnea (OSA) (J1I-MC-GSA1). This study will last about 89 weeks and will include up to 24 visits. Addendum (2) is optional and available to approximately 500 participants to continue treatment with retatrutide for up to an additional 24 weeks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 2335 (actual)
- First submitted
- 26 Jun 2023
- Start date
- 10 Jul 2023
- Primary completion date
- 6 Apr 2026
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity, Type 2 diabetes
- NCT number
- NCT05929066
- EU CT number
- 2023-503657-35-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 2335
- From 10 Jul 2023 to the primary completion date, 6 Apr 2026
- 133 sites in 12 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.
- Have had steroid joint injections within 90 days of screening.
- 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.
- GZBJ Addenda (2) exclusion criteria
Other illness
- Have diabetes mellitus.
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have joint disease other than osteoarthritis.
- GSA1 exclusion criteria
Other
- Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days.
- Have had pancreatitis.
- GOA1 exclusion criteria
- Have had other joint injections and procedures within 6 months of screening.
- Have had study intervention discontinuation.
- Have had permanent dose reduction.
Who the study is looking for
- Have body mass index (BMI) ≥30.0 kilograms per square meter (kg/m²), or ≥27.0 kg/m² with at least one of the following:
- hypertension
- dyslipidemia
- obstructive sleep apnea, or
- cardiovascular disease
- History of at least one unsuccessful dietary effort to reduce body weight
- GOA1 Inclusion Criteria:
- Have index knee pain for \>12 weeks prior to screening, and presence of index knee pain for \>15 days over the previous month
- Have knee X-ray with moderate radiographic changes (Kellgren-Lawrence Grade 2 or 3) per central reading at screening
- Currently meets American College of Rheumatology (ACR) Criteria (clinical and radiological) for OA.
- GSA1 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.
- GZBJ Addenda (2) inclusion criteria:
- Have completed the final treatment visit of GZBJ Week 80.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (133)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fusion Clinical Research Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Nightingale Research Coordinator of this site? Confirm its status | Adelaide | Australia | Unknown status |
| Emeritus Research Coordinator of this site? Confirm its status | Botany | Australia | Unknown status |
| Emeritus Research Coordinator of this site? Confirm its status | Camberwell | Australia | Unknown status |
| Barwon Health Coordinator of this site? Confirm its status | Geelong | Australia | Unknown status |
| Logan Hospital Coordinator of this site? Confirm its status | Meadowbrook | Australia | Unknown status |
| The AIM Centre / Hunter Diabetes Centre Coordinator of this site? Confirm its status | Merewether | Australia | Unknown status |
| One Clinical Research Coordinator of this site? Confirm its status | Nedlands | Australia | Unknown status |
| CPCLIN 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 |
| CPQuali Pesquisa Clínica Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Aggarwal and Associates Limited Coordinator of this site? Confirm its status | Brampton | Canada | Unknown status |
| Dr. Steven V. Zizzo Medicine Professional Corporation Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Wharton Medical Clinic Coordinator of this site? Confirm its status | Hamilton | Canada | Unknown status |
| Centre de recherche Clinique de Laval Coordinator of this site? Confirm its status | Laval | Canada | Unknown status |
| Clinique de médecine Urbaine du Quartier Latin Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Your Research Network Coordinator of this site? Confirm its status | Niagara Falls | Canada | Unknown status |
| Bluewater Clinical Research Group Inc. Coordinator of this site? Confirm its status | Sarnia | Canada | Unknown status |
| Canadian Phase Onward Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| C.I.C. Mauricie inc. Coordinator of this site? Confirm its status | Trois-Rivières | Canada | Unknown status |
| CHUAC-Complejo Hospitalario Universitario A Coruña Coordinator of this site? Confirm its status | A Coruña | Spain | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval Coordinator of this site? Confirm its status | Ferrol | Spain | Unknown status |
| Hospital Universitario Marqués de Valdecilla Coordinator of this site? Confirm its status | Santander | Spain | Unknown status |
| Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE) Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hospital General Universitario de Valencia Coordinator of this site? Confirm its status | Valencia | Spain | Unknown status |
| Heartlands Hospital Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| Layton Medical Centre Coordinator of this site? Confirm its status | Blackpool | United Kingdom | Unknown status |
| Rowden Surgery Coordinator of this site? Confirm its status | Chippenham | United Kingdom | Unknown status |
| Panthera Biopartners - North London Coordinator of this site? Confirm its status | Enfield | United Kingdom | Unknown status |
| Glasgow Royal Infirmary Coordinator of this site? Confirm its status | Glasgow | United Kingdom | Unknown status |
| Leicester General Hospital Coordinator of this site? Confirm its status | Leicester | United Kingdom | Unknown status |
| Aintree University Hospital NHS Foundation Trust Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
| St Clare Medical Centre Coordinator of this site? Confirm its status | Penzance | United Kingdom | Unknown status |
| Panthera Biopartners - Sheffield Coordinator of this site? Confirm its status | Sheffield | United Kingdom | Unknown status |
| DRC Gyógyszervizsgáló Központ Coordinator of this site? Confirm its status | Balatonfüred | Hungary | Unknown status |
| Óbudai Egészségügyi Centrum Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| ClinDiab Kft. Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Debreceni Egyetem Klinikai Kozpont Coordinator of this site? Confirm its status | Debrecen | Hungary | Unknown status |
| Medifarma-98 Kft. Coordinator of this site? Confirm its status | Nyíregyháza | Hungary | Unknown status |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Coordinator of this site? Confirm its status | Szeged | Hungary | Unknown status |
| Regia Med Kft Coordinator of this site? Confirm its status | Székesfehérvár | Hungary | Unknown status |
| Avron Hospitals Coordinator of this site? Confirm its status | Ahmedabad | India | Unknown status |
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
| Endolife Speciality Hospitals Coordinator of this site? Confirm its status | Guntur | India | Unknown status |
| Karnataka Institute of Medical Sciences Coordinator of this site? Confirm its status | Hubli | India | Unknown status |
| Eternal Heart Care Center and Research Institute Coordinator of this site? Confirm its status | Jaipur | India | Unknown status |
| ILS Hospitals Coordinator of this site? Confirm its status | Kolkata | India | Unknown status |
| Wockhardt Hospital - Mumbai Central Coordinator of this site? Confirm its status | Mumbai | India | Unknown status |
| Deenanath Mangeshkar Hospital & Research Centre Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Lifepoint Multispeciality Hospital Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Chellaram Diabetes Institute Coordinator of this site? Confirm its status | Pune | India | Unknown status |
| Surat Institute of Digestive Sciences Hospitals Coordinator of this site? Confirm its status | Surat | India | Unknown status |
| Indian Institute of Diabetes Coordinator of this site? Confirm its status | Thiruvananthapuram | India | Unknown status |
| Jothydev's Diabetes and Research Center Coordinator of this site? Confirm its status | Trivandrum | India | Unknown status |
| Christian Medical College Vellore Coordinator of this site? Confirm its status | Vellore | India | Unknown status |
| Centro de Atención e Investigación Clínica Coordinator of this site? Confirm its status | Aguascalientes | Mexico | 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 |
| Instituto de Diabetes, Obesidad y Nutricion Coordinator of this site? Confirm its status | Cuernavaca | Mexico | Unknown status |
| Clinica de Investigacion en Reumatologia y Obesidad S. C. Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Unidad de Investigación Clinica y atencion Medica HEPA 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 |
| Private Practice - Dr. Arechavaleta Granell Maria del Rosario Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Kohler and Milstein Research S.A. de C.V. Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Eme Red Hospitalaria Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Centro de Investigacion en Artritis y Osteoporosis SC Coordinator of this site? Confirm its status | Mexicali | Mexico | Unknown status |
| RM Pharma Specialists 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 |
| Unidad Biomedica Avanzada Monterrey Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Hospital Universitario Dr. Jose Eleuterio González Coordinator of this site? Confirm its status | Monterrey | Mexico | Unknown status |
| Arké SMO S.A de C.V Coordinator of this site? Confirm its status | Veracruz | Mexico | Unknown status |
| Uniwersytecki Szpital Kliniczny w Białymstoku Coordinator of this site? Confirm its status | Bialystok | Poland | Unknown status |
| INTERCOR Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Centrum Kliniczno-Badawcze Coordinator of this site? Confirm its status | Elblag | Poland | Unknown status |
| Ambulatorium Sp. z o.o. Coordinator of this site? Confirm its status | Elblag | Poland | Unknown status |
| Centrum Badan Klinicznych PI-House sp. z o.o. Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| NZOZ Salvia CM Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci Coordinator of this site? Confirm its status | Kielce | Poland | Unknown status |
| CenterMed Lublin NZOZ Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Gabinety TERPA Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Centrum Zdrowia Metabolicznego Pawel Bogdanski Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Private Practice - Dr. Robert Witek Coordinator of this site? Confirm its status | Tarnów | Poland | Unknown status |
| MICS Centrum Medyczne Warszawa Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Ponce Medical School Foundation Inc. Coordinator of this site? Confirm its status | Ponce | Puerto Rico | Unknown status |
| SC Minimed SRL Coordinator of this site? Confirm its status | Bacau | Romania | Unknown status |
| C.M.D.T.A. Neomed Coordinator of this site? Confirm its status | Brasov | Romania | Unknown status |
| Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| Diamed Obesity Coordinator of this site? Confirm its status | Galați | Romania | Unknown status |
| Centrul Medical Consultmed Coordinator of this site? Confirm its status | Iași | Romania | Unknown status |
| Gama Diamed Coordinator of this site? Confirm its status | Mangalia | Romania | Unknown status |
| Diabdana Coordinator of this site? Confirm its status | Oradea | Romania | Unknown status |
| Clinica Korall Coordinator of this site? Confirm its status | Satu Mare | Romania | Unknown status |
| Policlinica Astra Sibiu Coordinator of this site? Confirm its status | Sibiu | Romania | Unknown status |
| Cabinet Medical Dr.Geru Coordinator of this site? Confirm its status | Timișoara | Romania | Unknown status |
| NeuroTrials Research Inc Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| University of Colorado Anschutz Medical Campus Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| FutureSearch Trials of Neurology Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Great Lakes Research Group, Inc. Coordinator of this site? Confirm its status | Bay City | United States | Unknown status |
| Northwest Clinical Research Center Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Teradan Clinical trials LLC Coordinator of this site? Confirm its status | Brandon | United States | Unknown status |
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| StudyMetrix Research Coordinator of this site? Confirm its status | City of Saint Peters | United States | Unknown status |
| Altoona Center For Clinical Research Coordinator of this site? Confirm its status | Duncansville | United States | Unknown status |
| Lillestol Research Coordinator of this site? Confirm its status | Fargo | United States | Unknown status |
| Valley Research Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Neuro-Pain Medical Center Coordinator of this site? Confirm its status | Fresno | United States | Unknown status |
| Tribe Clinical Research LLC Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| East-West Medical Research Institute Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| Juno Research Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Brengle Family Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Palm Research Center Tenaya Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Medical Investigations Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Suncoast Research Group Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| New Horizon Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Carteret Medical Group Coordinator of this site? Confirm its status | Morehead City | United States | Unknown status |
| Vanderbilt Health One Hundred Oaks Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
| Advanced Research Institute Coordinator of this site? Confirm its status | Ogden | United States | Unknown status |
| Clinical Neuroscience Solutions Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Central Phoenix Medical Clinic Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Arizona Research Center Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Progressive Medical Research Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Rainier Clinical Research Center Coordinator of this site? Confirm its status | Renton | United States | Unknown status |
| Rochester Clinical Research, LLC Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Artemis Institute for Clinical Research Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Tribe Clinical Research - Spartanburg Coordinator of this site? Confirm its status | Spartanburg | United States | Unknown status |
| Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Clinvest Research, LLC Coordinator of this site? Confirm its status | Springfield | United States | Unknown status |
| Cotton O'Neil Diabetes & Endocrinology Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| MedVadis Research Corporation Coordinator of this site? Confirm its status | Waltham | United States | Unknown status |
| Chase Medical Research, LLC Coordinator of this site? Confirm its status | Waterbury | United States | Unknown status |
| Trial Management Associates - Wilmington - Floral Parkway Coordinator of this site? Confirm its status | Wilmington | United States | Unknown status |
| North Georgia Clinical Research Coordinator of this site? Confirm its status | Woodstock | United States | Unknown status |
Related publications
- Retatrutide Once Weekly for Treatment of Obstructive Sleep Apnea.N Engl J Med · 2026 · PMID 42904878
- Retatrutide, a Triple Hormone Receptor Agonist, for Treatment of Obesity.N Engl J Med · 2026 · PMID 42814954
This page is information, not medical advice. Discuss any trial with your doctor.