A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity
TRIUMPH-5
A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity
3 other identifiers
interventional
800
5 countries
65
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 obesity
Started Nov 2024
65 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 13, 2026
April 1, 2026
2.1 years
October 25, 2024
April 7, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Weight
Baseline, Week 80
Secondary Outcomes (9)
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
Baseline, Week 80
Percent Change from Baseline in Triglycerides
Baseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Baseline, Week 80
- +4 more secondary outcomes
Study Arms (2)
Retatrutide
EXPERIMENTALParticipants will receive retatrutide administered subcutaneously (SC)
Tirzepatide
ACTIVE COMPARATORParticipants will receive tirzepatide administered SC
Interventions
Eligibility Criteria
You may qualify if:
- Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight.
You may not qualify if:
- 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:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- coronary revascularization
- hospitalization for unstable angina, or
- hospitalization due to congestive heart failure.
- Have New York Heart Association Functional Classification Class IV congestive heart failure.
- Have a history of chronic or acute pancreatitis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (65)
Medical Advancement Centers of Arizona
Tempe, Arizona, 85283, United States
Mary & Dick Allen Diabetes Center
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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 Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2024
First Posted
October 28, 2024
Study Start
November 1, 2024
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- 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.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.