Obesity Clinical Trial
— TRIUMPH-2Official 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.
| Status | Recruiting |
| Enrollment | 1000 |
| Est. completion date | May 31, 2026 |
| Est. primary completion date | May 3, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Centro Médico Viamonte | Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Argentina | Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Ciudad Autonoma de Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Argentina | Consultorio de Investigación Clínica EMO SRL | Ciudad Autonoma de Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Argentina | Centro de Salud e Investigaciones Médicas | Santa Rosa | La Pampa |
| Australia | Nightingale Research | Adelaide | South Australia |
| Australia | Flinders University | Bedford Park | South Australia |
| Australia | Optimus Clinical Research | Botany | New South Wales |
| Australia | Box Hill Hospital | Box Hill | Victoria |
| Australia | Core Research Group | Brisbane | Queensland |
| Australia | Royal Brisbane and Women's Hospital | Brisbane | Queensland |
| Australia | Emeritus Research | Camberwell | Victoria |
| Australia | Austin Health - Repatriation Hospital | Heidelberg West | Victoria |
| Australia | GenesisCare | Joondalup | Western Australia |
| Australia | The AIM Centre / Hunter Diabetes Centre | Merewether | New South Wales |
| Australia | Southern Adelaide Diabetes & Endocrine Services | Oaklands Park | South Australia |
| Australia | Woolcock Institute of Medical Research | Sydney | New South Wales |
| Brazil | BR Trials - Ensaios Clinicos e Consultoria | Sao Paulo | |
| Brazil | CEPIC - Centro Paulista de Investigação Clínica | São Paulo | |
| Brazil | CPQuali Pesquisa Clínica | São Paulo | |
| India | Avron Hospitals | Ahmedabad | Gujarat |
| India | V.S. General Hospital | Ahmedabad | Gujarat |
| India | Zydus Hospitals & Healthcare Research Pvt.Ltd. | Ahmedabad | Gujarat |
| India | Life Care Hospital and Research Centre | Bangalore | Karnataka |
| India | Madras Diabetes Research Foundation | Chennai | Tamil Nadu |
| India | Sushruta Multispeciality Hospital & Research Centre | Hubli | Karnataka |
| India | Care Hospitals Hyderabad- Banjara Hills | Hyderabad | Telangana |
| India | Kumudini Devi Diabetes Research Center | Hyderabad | Telangana |
| India | CARE CHL-Hospitals | Indore | Madhya Pradesh |
| India | Sawai Man Singh Medical College Hospital (SMS Hospital) | Jaipur | Rajasthan |
| India | Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital | Kolkata | West Bengal |
| India | Mysore Medical College | Mysore | Karnataka |
| India | All India Institute of Medical Sciences | Raipur | Chhattisgarh |
| India | Christian Medical College Vellore | Vellore | Tamil Nadu |
| Mexico | Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos | Chihuahua | |
| Mexico | Instituto de Diabetes, Obesidad y Nutricion | Cuernavaca | Morelos |
| Mexico | Diseno y Planeacion en Investigacion Medica | Guadalajara | Jalisco |
| Mexico | Private Practice - Dr. Arechavaleta Granell Maria del Rosario | Guadalajara | Jalisco |
| Mexico | Unidad de Investigación Clínica y Atención Médica HEPA | Guadalajara | Jalisco |
| Mexico | Kohler and Milstein Research S.A. de C.V. | Mérida | Yucatán |
| Mexico | Centro de Investigacion en Artritis y Osteoporosis SC | Mexicali | Baja California |
| Mexico | Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares | Mexico City | Distrito Federal |
| Mexico | Clinica Omega | Mexico City | Distrito Federal |
| Mexico | RM Pharma Specialists | Mexico City | Distrito Federal |
| Mexico | Cardiolink Clin Trials | Monterrey | Nuevo León |
| Mexico | Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey | Nuevo León |
| Mexico | Unidad biomedica avanzada monterrey | Monterrey | Nuevo León |
| Mexico | Arké SMO S.A de C.V | Veracruz | |
| Mexico | FAICIC S. de R.L. de C.V. | Veracruz | |
| Romania | CMI Dr.Pletea Noemi SRL | Bacau | |
| Romania | Centrul Medical NutriLife | Bucharest | Bucure?ti |
| Romania | Geea Medical Easy Diet | Bucharest | Bucure?ti |
| Romania | Gama Diamed | Mangalia | Constan?a |
| Romania | Diabdana | Oradea | Bihor |
| Romania | Centrul Medical Mediab | Târgu-Mure? | Mure? |
| Spain | Centro Periférico de Especialidades Bola Azul | Almeria | Almería |
| Spain | Complejo Asistencial Universitario de León - Hospital de León | León | Castilla Y León |
| Spain | Hospital Universitario Ramón y Cajal | Madrid | Madrid, Comunidad De |
| Spain | Hospital Universitario Virgen de la Victoria | Malaga | Andalucía |
| Spain | H.R.U Málaga - Hospital Civil | Málaga | Andalucía |
| Spain | Hospital Universitario Virgen Del Rocio | Sevilla | |
| Spain | Vithas Hospital Sevilla | Seville | Sevilla |
| Taiwan | Chang Gung Memorial Hospital at Kaohsiung | Kaohsiung Niao Sung Dist | Kaohsiung |
| Taiwan | Chung Shan Medical University Hospital | Taichung City | Taichung |
| Taiwan | Taipei Veterans General Hospital | Taipei City | Taipei |
| United States | Pinnacle Research Group, LLC | Anniston | Alabama |
| United States | NeuroTrials Research Inc | Atlanta | Georgia |
| United States | FutureSearch Trials of Neurology | Austin | Texas |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | Excel Medical Clinical Trials | Boca Raton | Florida |
| United States | Teradan Clinical Trials, LLC | Brandon | Florida |
| United States | Core Healthcare Group | Cerritos | California |
| United States | CTI-CRC | Cincinnati | Ohio |
| United States | Intrepid Research | Cincinnati | Ohio |
| United States | Cullman Clinical Trials | Cullman | Alabama |
| United States | Dallas Diabetes Research Center | Dallas | Texas |
| United States | Lillestol Research | Fargo | North Dakota |
| United States | Fleming Island Center for Clinical Research | Fleming Island | Florida |
| United States | Therafirst Medical Center | Fort Lauderdale | Florida |
| United States | Tribe Clinical Research, LLC | Greenville | South Carolina |
| United States | East-West Medical Research Institute | Honolulu | Hawaii |
| United States | Brengle Family Medicine | Indianapolis | Indiana |
| United States | Las Vegas Medical Research | Las Vegas | Nevada |
| United States | Preferred Research Partners | Little Rock | Arkansas |
| United States | National Research Institute - Wilshire | Los Angeles | California |
| United States | Clinical Site Partners LLC, dba Flourish Research | Miami | Florida |
| United States | Quantum Clinical Trials | Miami Beach | Florida |
| United States | Monroe Biomedical Research | Monroe | North Carolina |
| United States | Carteret Medical Group | Morehead City | North Carolina |
| United States | Trial Management Associates | Myrtle Beach | South Carolina |
| United States | Mid Hudson Medical Research | New Windsor | New York |
| United States | Valley Clinical Trials, Inc. | Northridge | California |
| United States | Renstar Medical Research | Ocala | Florida |
| United States | Advanced Research Institute | Ogden | Utah |
| United States | Office 18 | Pittsburgh | Pennsylvania |
| United States | Clinical Research Center of Florida | Pompano Beach | Florida |
| United States | Centricity Research Rincon Pulmonology | Rincon | Georgia |
| United States | StudyMetrix Research | Saint Peters | Missouri |
| United States | Tribe Clinical Research - Spartanburg | Spartanburg | South Carolina |
| United States | Preferred Primary Care Physicians | Uniontown | Pennsylvania |
| United States | Diablo Clinical Research, Inc. | Walnut Creek | California |
| United States | MedVadis Research Corporation | Waltham | Massachusetts |
| United States | Chase Medical Research, LLC | Waterbury | Connecticut |
| United States | Palm Beach Research Center | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States, Argentina, Australia, Brazil, India, Mexico, Romania, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent Change from Baseline in Body Weight | Baseline, Week 80 | ||
| Primary | Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset | Baseline, Week 80 | ||
| Secondary | Change from Baseline in Body Mass Index (BMI) | Baseline, Week 80 | ||
| Secondary | Change from Baseline in Waist Circumference | Baseline, Week 80 | ||
| Secondary | Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 80 | ||
| Secondary | Change from Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 80 | ||
| Secondary | Percent Change from Baseline in Total Cholesterol | Baseline, Week 80 | ||
| Secondary | Percent Change from Baseline in Triglycerides | Baseline, Week 80 | ||
| Secondary | Change from Baseline in Hemoglobin (A1c) HbA1c % | Baseline, Week 80 | ||
| Secondary | Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score | Baseline, Week 80 | ||
| Secondary | Change from Baseline in Fasting Glucose | Baseline, Week 80 | ||
| Secondary | 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. | Baseline through Week 80 | |
| Secondary | Percent Change from Baseline in Apnea-Hypopnea Index (AHI) for GSA2 Subset | Baseline, Week 80 | ||
| Secondary | 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. | Baseline to Week 80 | |
| Secondary | Percentage of Participants with =50% AHI Reduction from Baseline for GSA2 Subset | Baseline to Week 80 | ||
| Secondary | Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) =10 for GSA2 Subset | Week 80 |
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