A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight
TRIUMPH-1
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)
5 other identifiers
interventional
2,300
12 countries
134
Brief Summary
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.
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 Jul 2023
Typical duration for phase_3 obesity
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
July 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedApril 18, 2025
April 1, 2025
2.7 years
June 26, 2023
April 17, 2025
Conditions
Outcome Measures
Primary Outcomes (4)
Percent Change From Baseline in Body Weight
Baseline, Week 80
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score for GOA1 Subset
Baseline, Week 80
Change from Baseline in Apnea-Hypopnea Index (AHI) Events Per Hour for GSA1 Subset
Baseline, Week 80
Percent Change from Baseline in Body Weight to
Baseline, Week 104
Secondary Outcomes (14)
Change from Baseline in Body Mass Index (BMI)
Baseline, Week 80
Change from Baseline in Waist Circumference
Baseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)
Baseline, Week 80
Percent Change form Baseline in Fasting Insulin
Baseline, Week 80
Change from Baseline in HbA1c
Baseline, Week 80
- +9 more secondary outcomes
Study Arms (5)
Retatrutide Dose 1
EXPERIMENTALParticipants will receive retatrutide subcutaneously (SC).
Retatrutide Dose 2
EXPERIMENTALParticipants will receive retatrutide SC.
Retatrutide Dose 3
EXPERIMENTALParticipants will receive retatrutide SC.
Placebo
PLACEBO COMPARATORParticipants will receive placebo.
Retatrutide Extension Period
EXPERIMENTALParticipants will receive retatrutide after the placebo-controlled 80 week treatment period for an additional 24 weeks.
Interventions
Administered SC
Eligibility Criteria
You may qualify if:
- 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 of at least one unsuccessful dietary effort to reduce body weight
- 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.
- 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.
- Have completed the final treatment visit of GZBJ Week 80.
You may not qualify if:
- 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 diabetes mellitus.
- Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had pancreatitis.
- Have had steroid joint injections within 90 days of screening.
- Have had other joint injections and procedures within 6 months of screening.
- Have joint disease other than osteoarthritis.
- 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.
- Have had study intervention discontinuation.
- Have had permanent dose reduction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (134)
Central Phoenix Medical Clinic
Phoenix, Arizona, 85020, United States
Arizona Research Center
Phoenix, Arizona, 85053, United States
Medical Investigations
Little Rock, Arkansas, 72211, United States
Neuro-Pain Medical Center
Fresno, California, 93710, United States
Valley Research
Fresno, California, 93720, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Teradan Clinical Trials, LLC
Brandon, Florida, 33511, United States
Suncoast Research Group
Miami, Florida, 33135, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Clinical Neuroscience Solutions
Orlando, Florida, 32801, United States
Progressive Medical Research
Port Orange, Florida, 32127, United States
NeuroTrials Research Inc
Atlanta, Georgia, 30328, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Northwestern University
Chicago, Illinois, 60611, United States
Central Illinois Diabetes and Clinical Research a Division of Prairie Education and Research Cooperative
Springfield, Illinois, 62711, United States
Brengle Family Medicine
Indianapolis, Indiana, 46260, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Palm Research Center Tenaya
Las Vegas, Nevada, 89128, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, 28403, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, 16635, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Tribe Clinical Research - Spartanburg
Spartanburg, South Carolina, 29301, United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 37204, United States
FutureSearch Trials of Neurology
Austin, Texas, 78731, United States
Juno Research
Houston, Texas, 77040, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Emeritus Research
Botany, New South Wales, 2019, Australia
The AIM Centre / Hunter Diabetes Centre
Merewether, New South Wales, 2291, Australia
Logan Hospital
Meadowbrook, Queensland, 4131, Australia
Fusion Clinical Research
Adelaide, South Australia, 5000, Australia
Nightingale Research
Adelaide, South Aust, 5000, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Barwon Health
Geelong, Victoria, 3220, Australia
One Clinical Research
Nedlands, Western Australia, 6009, Australia
CPCLIN
São Paulo, São Paulo, 01228-200, Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000, Brazil
CEPIC - Centro Paulista de Investigação Clínica
São Paulo, 04266-010, Brazil
Aggarwal and Associates Limited
Brampton, Ontario, L6T 0G1, Canada
Dr. Steven V. Zizzo Medicine Professional Corporation
Hamilton, Ontario, L8J 0B6, Canada
Wharton Medical Clinic
Hamilton, Ontario, L8L 5G8, Canada
Your Research Network
Niagara Falls, Ontario, L2H 1H5, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3, Canada
Canadian Phase Onward
Toronto, Ontario, M3J 0K2, Canada
Centre de Recherche Clinique de Laval
Laval, Quebec, H7T 2P5, Canada
Clinique de médecine Urbaine du Quartier Latin
Montreal, Quebec, H2L 4E9, Canada
C.I.C. Mauricie inc.
Trois-Rivières, Quebec, G8T 7A1, Canada
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, 6725, Hungary
Regia Med Kft
Székesfehérvár, Fejér, 8000, Hungary
Medifarma 98 Kft
Nyíregyháza, Nyíregyháza, 4400, Hungary
DRC Gyógyszervizsgáló Központ
Balatonfüred, Veszprém megye, 8230, Hungary
Óbudai Egészségügyi Centrum
Budapest, 1036, Hungary
ClinDiab Kft.
Budapest, 1089, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, 4031, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032, Hungary
Endolife Speciality Hospitals
Guntur, Andhra Pradesh, 522001, India
Avron Hospitals
Ahmedabad, Gujarat, 380013, India
Surat Institute of Digestive Sciences Hospitals
Surat, Gujarat, 395002, India
Karnataka Institute of Medical Sciences
Hubli, Karnataka, 580021, India
Indian Institute of Diabetes
Thiruvananthapuram, Kerala, 695031, India
Jothydev's Diabetes and Research Center
Trivandrum, Kerala, 695032, India
Wockhardt Hospital - Mumbai Central
Mumbai, Maharashtra, 400011, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, 411004, India
Chellaram Diabetes Institute
Pune, Maharashtra, 411021, India
Lifepoint Multispeciality Hospital
Pune, Maharashtra, 411057, India
All India Institute of Medical Sciences
Bhubaneswar, Odisha, 751019, India
Eternal Heart Care Center and Research Institute
Jaipur, Rajasthan, 302020, India
Christian Medical College Vellore
Vellore, Tamil Nadu, 632004, India
ILS Hospitals
Kolkata, West Benga, 700064, India
Centro de Investigacion en Artritis y Osteoporosis SC
Mexicali, Estado de Baja California, 21200, Mexico
Diseno y Planeacion en Investigacion Medica
Guadalajara, Jalisco, 44130, Mexico
Clinica de Investigacion en Reumatologia y Obesidad S. C.
Guadalajara, Jalisco, 44650, Mexico
Private Practice - Dr. Arechavaleta Granell Maria del Rosario
Guadalajara, Jalisco, 44670, Mexico
Unidad de Investigación Clínica y Atención Médica HEPA
Guadalajara, Jalisco, 44670, Mexico
RM Pharma Specialists
Mexico City, Mexico City, 03100, Mexico
Clinica Omega
Mexico City, Mexico City, 06700, Mexico
Instituto de Diabetes, Obesidad y Nutricion
Cuernavaca, Morelos, 62250, Mexico
Unidad biomedica avanzada monterrey
Monterrey, Nuevo León, 64460, Mexico
Hospital Universitario Dr. Jose Eleuterio Gonzalez
Monterrey, Nuevo León, 66460, Mexico
EME RED Hospitalaria
Mérida, Yucatán, 97000, Mexico
Kohler and Milstein Research S.A. de C.V.
Mérida, Yucatán, 97070, Mexico
Centro de Atención e Investigación Clínica
Aguascalientes, 20119, Mexico
Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
Chihuahua City, 31110, Mexico
Arké SMO S.A de C.V
Veracruz, 91910, Mexico
Centrum Zdrowia Metabolicznego Pawel Bogdanski
Poznan, Greater Poland Voivodeship, 60-589, Poland
INTERCOR
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-605, Poland
Private Practice - Dr. Robert Witek
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
CenterMed Lublin NZOZ
Lublin, Lublin Voivodeship, 20-044, Poland
Gabinety TERPA
Lublin, Lublin Voivodeship, 20-333, Poland
MICS Centrum Medyczne Warszawa
Warsaw, Masovian Voivodeship, 00-874, Poland
Uniwersytecki Szpital Kliniczny w Białymstoku
Bialystok, Podlaskie Voivodeship, 15-276, Poland
Centrum Badan Klinicznych PI-House sp. z o.o.
Gdansk, Pomeranian Voivodeship, 80-546, Poland
NZOZ Salvia CM
Katowice, Silesian Voivodeship, 40-772, Poland
Ambulatorium Sp. z o.o.
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Centrum Kliniczno-Badawcze
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Specjalistyczna Praktyka Lekarska Diabetologia, Leczenie Cukrzycy i Otylosci
Kielce, Świętokrzyskie Voivodeship, 25-355, Poland
Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
Diabdana
Oradea, Bihor County, 410147, Romania
C.M.D.T.A. Neomed
Brasov, Brașov County, 500283, Romania
Hightech Medical Services SRL-Centrul pentru Studiul Metabolismului
Bucharest, București, 011053, Romania
Gama Diamed
Mangalia, Constanța County, 905500, Romania
Cabinet Medical Dr.Geru
Timișoara, Timiș County, 300288, Romania
SC Minimed SRL
Bacau, 600274, Romania
Diamed Obesity
Galați, 800291, Romania
Centrul Medical Consultmed
Iași, 700547, Romania
Clinica Korall
Satu Mare, 440055, Romania
Policlinica Astra Sibiu
Sibiu, 550371, Romania
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, A Coruña [La Coruña], 15006, Spain
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
Ferrol, A Coruña [La Coruña], 15405, Spain
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], 08035, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital General Universitario de Valencia
Valencia, Valenciana, Comunitat, 46014, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003, Spain
Rowden Surgery
Chippenham, England, SN15 2SB, United Kingdom
Layton Medical Centre
Blackpool, Lancashire, FY3 7EN, United Kingdom
Leicester General Hospital
Leicester, Leicestershire, LE5 4PW, United Kingdom
Panthera Biopartners - North London
Enfield, London, City of, EN3 4GS, United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, G31 2ER, United Kingdom
Heartlands Hospital
Birmingham, B9 5SS, United Kingdom
Aintree University Hospital NHS Foundation Trust
Liverpool, L9 7AL, United Kingdom
St Clare Medical Centre
Penzance, TR18 3DX, United Kingdom
Panthera Biopartners - Sheffield
Sheffield, S2 5FX, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition 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
June 26, 2023
First Posted
July 3, 2023
Study Start
July 10, 2023
Primary Completion
April 1, 2026
Study Completion
May 1, 2026
Last Updated
April 18, 2025
Record last verified: 2025-04
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 European Union (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.