A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
TRIUMPH-4
A Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial
3 other identifiers
interventional
445
6 countries
49
Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of retatrutide once-weekly in participants who have obesity or are overweight and have osteoarthritis (OA) of the knee. The study will lasts about 77 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 obesity
Started Aug 2023
Typical duration for phase_3 obesity
49 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
June 27, 2023
CompletedFirst Posted
Study publicly available on registry
July 5, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 14, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 14, 2025
CompletedJanuary 21, 2026
January 1, 2026
2.3 years
June 27, 2023
January 20, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Baseline, Week 68
Percent Change from Baseline in Body Weight
Baseline, Week 68
Secondary Outcomes (11)
Change from Baseline in the WOMAC Physical Function Subscale Score
Baseline, Week 68
Change from Baseline in Waist Circumference
Baseline, Week 68
Percent Change from Baseline in Total Cholesterol
Baseline, Week 68
Percent Change from Baseline in Triglycerides
Baseline, Week 68
Change from Baseline in Body Mass Index (BMI)
Baseline, Week 68
- +6 more secondary outcomes
Study Arms (3)
Retatrutide Dose 1
EXPERIMENTALParticipants will receive retatrutide subcutaneously (SC).
Retatrutide Dose 2
EXPERIMENTALParticipants will receive retatrutide SC.
Placebo
PLACEBO COMPARATORParticipants will receive placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Have a body mass index (BMI) ≥27 kilogram/kg/m² at screening.
- Have a history of at least 1 self-reported unsuccessful dietary effort to lose 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.
You may not qualify if:
- 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.
- Have a self-reported or documented change in body weight \>5 kg (11 pounds) within 90 days prior to screening.
- Have been taking 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Arizona Research Center
Phoenix, Arizona, 85053, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Chase Medical Research, LLC
Waterbury, Connecticut, 06708, United States
Suncoast Research Group
Miami, Florida, 33135, United States
North Georgia Clinical Research
Woodstock, Georgia, 30189, United States
Elite Clinical Trials
Blackfoot, Idaho, 83221, United States
Northwestern University
Chicago, Illinois, 60611, United States
MedVadis Research Corporation
Waltham, Massachusetts, 02451, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, 48706, United States
Clinvest Research LLC
Springfield, Missouri, 65807, United States
Mercy Family Clinic
Dallas, Texas, 75211, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Paratus Clinical Research Canberra
Bruce, Australian Capital Territory, 2617, Australia
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148, Australia
Emeritus Research
Botany, New South Wales, 2019, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Core Research Group
Brisbane, Queensland, 4064, Australia
CDH Research Institute
Maroochydore, Queensland, 4558, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Barwon Health
Geelong, Victoria, 3220, Australia
C-health Research
Calgary, Alberta, T2V 4J2, Canada
Eastern Health - General Hospital
St. John's, Newfoundland and Labrador, A1B 3V6, Canada
Viable Clinical Research
Bridgewater, Nova Scotia, B4V 3N2, Canada
Wharton Medical Clinic
Hamilton, Ontario, L8L 5G8, Canada
Bluewater Clinical Research Group Inc.
Sarnia, Ontario, N7T 4X3, Canada
Viable Clinical Research
Scarborough Village, Ontario, M1P 2T7, Canada
Stouffville Medical Research Institute Inc.
Stouffville, Ontario, L4A 1H2, Canada
Canadian Phase Onward
Toronto, Ontario, M3J 0K2, Canada
Alpha Recherche Clinique
Québec, G2J 0C4, Canada
ALPHA Recherche Clinique
Québec, G3K 2P8, Canada
Consultorio Médico
Guadalajara, Jalisco, 44210, Mexico
IMED Internal Medicine Clin Trials
Monterrey, Nuevo León, 64020, Mexico
Clínica García Flores SC
Monterrey, Nuevo León, 64610, Mexico
Unidad Médica para la Salud Integral
San Nicolás de los Garza, Nuevo León, 66465, Mexico
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
Ciudad Madero, Tamaulipas, 89440, Mexico
Kohler and Milstein Research S.A. de C.V.
Mérida, Yucatán, 97070, Mexico
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000, Mexico
Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval")
Ferrol, A Coruña, 15405, Spain
Hospital Universitario Reina Sofia
Córdoba, Andalusia, 14004, Spain
Hospital Quirón Málaga
Málaga, Andalusia, 29004, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08041, Spain
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28702, Spain
Hospital General Universitario de Valencia
Valencia, Valenciana, 46014, Spain
CHUAC-Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville, 41003, Spain
Leicester General Hospital
Leicester, Leicestershire, LE5 4PW, United Kingdom
Panthera Biopartners - North London
Enfield, London, EN3 4GS, 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 27, 2023
First Posted
July 5, 2023
Study Start
August 1, 2023
Primary Completion
November 14, 2025
Study Completion
November 14, 2025
Last Updated
January 21, 2026
Record last verified: 2026-01
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.