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| ID | Type | Description | Link |
|---|---|---|---|
| J1I-MC-GZBP | Other Identifier | Eli Lilly and Company | |
| 2024-511450-49-00 | EU Trial (CTIS) Number |
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The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retatrutide | Experimental | Participants will receive retatrutide administered subcutaneously (SC) |
|
| Tirzepatide | Active Comparator | Participants will receive tirzepatide administered SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retatrutide | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change from Baseline in Body Weight | Baseline, Week 80 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Body Mass Index (BMI) | Baseline, Week 80 | |
| Change from Baseline in Waist Circumference | Baseline, Week 80 | |
| Percent Change from Baseline in Total Cholesterol |
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Inclusion Criteria:
Exclusion Criteria:
Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days before screening.
Have a prior or planned surgical treatment for obesity.
Have a prior or planned endoscopic procedure and/or device-based therapy for obesity.
Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
Have had within the past 90 days before screening:
Have New York Heart Association Functional Classification Class IV congestive heart failure.
Have a history of chronic or acute pancreatitis.
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Advancement Centers of Arizona | Tempe | Arizona | 85283 | United States | ||
| Mary & Dick Allen Diabetes Center |
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| Label | URL |
|---|---|
| A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity (TRIUMPH-5) | View source |
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Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| Tirzepatide | Drug | Administered SC |
|
|
| Baseline, Week 80 |
| Percent Change from Baseline in Triglycerides | Baseline, Week 80 |
| Change from Baseline in Systolic Blood Pressure (SBP) | Baseline, Week 80 |
| Change from Baseline in Diastolic Blood Pressure (DBP) | Baseline, Week 80 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline, Week 80 |
| Percent Change from Baseline in Fasting Insulin | Baseline, Week 80 |
| Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) | Baseline, Week 80 |
| Newport Beach |
| California |
| 92663 |
| United States |
| Artemis Institute for Clinical Research | San Diego | California | 92103 | United States |
| Encompass Clinical Research | Spring Valley | California | 91978 | United States |
| Diablo Clinical Research, Inc. | Walnut Creek | California | 94598 | United States |
| Lynn Institute of Denver | Aurora | Colorado | 80012 | United States |
| Bridgeport Hospital | Bridgeport | Connecticut | 06610 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06519 | United States |
| Encore Medical Research | Hollywood | Florida | 33024 | United States |
| Suncoast Research Group | Miami | Florida | 33135 | United States |
| Onhealth Research Center | Miami | Florida | 33186 | United States |
| Precision Clinical Research | Sunrise | Florida | 33351 | United States |
| Einstein Clinical Research | Vero Beach | Florida | 32960 | United States |
| ClinCept Clinical Research - MH | Columbus | Georgia | 31904 | United States |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | United States |
| Pivotal Research Solutions | Stonecrest | Georgia | 30038 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96814 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| Integrated Clinical Trial Services, Inc. | West Des Moines | Iowa | 50265 | United States |
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| Great Lakes Research Group, Inc. | Bay City | Michigan | 48706 | United States |
| Great Lakes Research Institute | Southfield | Michigan | 48075 | United States |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | United States |
| Las Vegas Endocrinology | Henderson | Nevada | 89074 | United States |
| Albany Medical College, Division of Community Endocrinology | Albany | New York | 12203 | United States |
| New York Gastroenterology Associates | New York | New York | 10075 | United States |
| Westchester Medical Center | Valhalla | New York | 10595 | United States |
| PharmQuest Life Sciences, LLC | Greensboro | North Carolina | 27408 | United States |
| Monroe Biomedical Research | Monroe | North Carolina | 28112 | United States |
| Accellacare - Wilmington | Wilmington | North Carolina | 28401 | United States |
| Lillestol Research | Fargo | North Dakota | 58104 | United States |
| PriMED Clinical Research | Dayton | Ohio | 45429 | United States |
| Tribe Clinical Research, LLC | Greenville | South Carolina | 29607 | United States |
| WR-Clinsearch, LLC | Chattanooga | Tennessee | 37421 | United States |
| Headlands Horizons LLC | Brownsville | Texas | 78526 | United States |
| Next Level Urgent Care | Houston | Texas | 77057 | United States |
| Houston Research Institute | Houston | Texas | 77079 | United States |
| Consano Clinical Research, LLC | Shavano Park | Texas | 78231 | United States |
| Chrysalis Clinical Research | St. George | Utah | 84790 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| DIM Clínica Privada | Ramos Mejía | Buenos Aires | B1704ETD | Argentina |
| Centro Médico Viamonte | Buenos Aires | Buenos Aires F.D. | C1120AAC | Argentina |
| Consultorio de Investigación Clínica EMO SRL | Buenos Aires | Buenos Aires F.D. | C1405BUB | Argentina |
| Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada | Buenos Aires | Buenos Aires F.D. | C1425AGC | Argentina |
| Centro de Investigaciones Metabólicas (CINME) | Buenos Aires | C1056ABI | Argentina |
| Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob | Villingen-Schwenningen | Baden-Wurttemberg | 78048 | Germany |
| Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz | Lingen | Lower Saxony | 49808 | Germany |
| Zentrum fur klinische Forschung - Köln | Cologne | North Rhine-Westphalia | 51069 | Germany |
| InnoDiab Forschung Gmbh | Essen | North Rhine-Westphalia | 45136 | Germany |
| Medizentrum Essen Borbeck | Essen | North Rhine-Westphalia | 45355 | Germany |
| AmBeNet GmbH | Leipzig | Saxony | 04107 | Germany |
| RED-Institut GmbH | Oldenburg in Holstein | Schleswig-Holstein | 23758 | Germany |
| Diabetes Zentrum Wilhelmsburg | Hamburg | 21109 | Germany |
| Diabeteszentrum Hamburg West | Hamburg | 22607 | Germany |
| Centrum Zdrowia Metabolicznego Pawel Bogdanski | Poznan | Greater Poland Voivodeship | 60-589 | Poland |
| Nzoz Neuro-Kard Ilkowski i Partnerzy SPL | Poznan | Greater Poland Voivodeship | 61-853 | Poland |
| Gabinety TERPA | Lublin | Lublin Voivodeship | 20-333 | Poland |
| Ekamed | Lublin | Lublin Voivodeship | 20-718 | Poland |
| Uniwersytecki Szpital Kliniczny w Białymstoku | Bialystok | Podlaskie Voivodeship | 15-276 | Poland |
| Gabinet Leczenia Otylosci i Chorob Dietozaleznych - dr hab. n. med. Lucyna Ostrowska | Bialystok | Podlaskie Voivodeship | 15-281 | Poland |
| Zdrowie Osteo-Medic | Bialystok | Podlaskie Voivodeship | 15-351 | Poland |
| NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny | Bialystok | Podlaskie Voivodeship | 15-435 | Poland |
| NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki | Ruda Śląska | Silesian Voivodeship | 41-709 | Poland |
| Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna | Lodz | Łódź Voivodeship | 90-338 | Poland |
| Ponce Medical School Foundation Inc. | Ponce | 00716 | Puerto Rico |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000729679 | retatrutide |
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |
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