Back to resultsA Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee (TRIUMPH-4)
Primary Purpose
Obesity, Overweight, Osteo Arthritis Knee
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Retatrutide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obesity
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Arizona Research CenterRecruiting
- Artemis Institute for Clinical ResearchRecruiting
- Chase Medical Research, LLCRecruiting
- Suncoast Research GroupRecruiting
- North Georgia Clinical ResearchRecruiting
- Northwestern UniversityRecruiting
- MedVadis Research CorporationRecruiting
- Great Lakes Research Group, Inc.Recruiting
- Clinvest Research LLCRecruiting
- Mercy Family ClinicRecruiting
- Clinical Trials of Texas, Inc.Recruiting
- Northwest Clinical Research CenterRecruiting
- Paratus Clinical Research CanberraRecruiting
- Optimus Clinical ResearchRecruiting
- Royal Brisbane and Women's Hospital
- Core Research GroupRecruiting
- Coastal Digestive HealthRecruiting
- Emeritus ResearchRecruiting
- Barwon HealthRecruiting
- C-health ResearchRecruiting
- Viable Clinical ResearchRecruiting
- Wharton Medical Clinic
- Bluewater Clinical Research Group Inc.Recruiting
- Viable Clinical ResearchRecruiting
- Stouffville Medical CentreRecruiting
- Canadian Phase OnwardRecruiting
- Alpha Recherche CliniqueRecruiting
- ALPHA Recherche CliniqueRecruiting
- Consultorio Médico
- IMED Internal Medicine Clin TrialsRecruiting
- Clínica García Flores SCRecruiting
- Unidad Médica para la Salud Integral
- Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
- Kohler and Milstein Research S.A. de C.V.
- Investigacion y Biomedicina de Chihuahua
- CHUAC-Complejo Hospitalario Universitario A CoruñaRecruiting
- Hospital General Universitario de ValenciaRecruiting
- Hospital Quirón MálagaRecruiting
- Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)Recruiting
- Leicester General Hospital
- Panthera Biopartners - North LondonRecruiting
- Panthera Biopartners - SheffieldRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Retatrutide Dose 1
Retatrutide Dose 2
Placebo
Arm Description
Participants will receive retatrutide subcutaneously (SC).
Participants will receive retatrutide SC.
Participants will receive placebo.
Outcomes
Primary Outcome Measures
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Percent Change from Baseline in Body Weight
Secondary Outcome Measures
Change from Baseline in the WOMAC Physical Function Subscale Score
Change from Baseline in Waist Circumference
Percent Change from Baseline in Total Cholesterol
Percent Change from Baseline in Triglycerides
Change from Baseline in Body Mass Index (BMI)
Change from Baseline in Systolic Blood Pressure (SBP)
Change from Baseline in Diastolic Blood Pressure (DBP)
Percent Change from Baseline in Fasting Insulin
Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score
Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05931367
Brief Title
A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
Acronym
TRIUMPH-4
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
February 6, 2026 (Anticipated)
Study Completion Date
March 8, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Osteo Arthritis Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
405 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Retatrutide Dose 1
Arm Type
Experimental
Arm Description
Participants will receive retatrutide subcutaneously (SC).
Arm Title
Retatrutide Dose 2
Arm Type
Experimental
Arm Description
Participants will receive retatrutide SC.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo.
Intervention Type
Drug
Intervention Name(s)
Retatrutide
Other Intervention Name(s)
LY3437943
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Time Frame
Baseline, Week 68
Title
Percent Change from Baseline in Body Weight
Time Frame
Baseline, Week 68
Secondary Outcome Measure Information:
Title
Change from Baseline in the WOMAC Physical Function Subscale Score
Time Frame
Baseline, Week 68
Title
Change from Baseline in Waist Circumference
Time Frame
Baseline, Week 68
Title
Percent Change from Baseline in Total Cholesterol
Time Frame
Baseline, Week 68
Title
Percent Change from Baseline in Triglycerides
Time Frame
Baseline, Week 68
Title
Change from Baseline in Body Mass Index (BMI)
Time Frame
Baseline, Week 68
Title
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame
Baseline, Week 68
Title
Change from Baseline in Diastolic Blood Pressure (DBP)
Time Frame
Baseline, Week 68
Title
Percent Change from Baseline in Fasting Insulin
Time Frame
Baseline, Week 68
Title
Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Time Frame
Baseline, Week 68
Title
Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score
Time Frame
Baseline, Week 68
Title
Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score
Time Frame
Baseline, Week 68
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Phone
1-317-615-4559
Email
ClinicalTrials.gov@lilly.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
602-863-6363
First Name & Middle Initial & Last Name & Degree
Louise A. Taber MD
Facility Name
Artemis Institute for Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Layle
Facility Name
Chase Medical Research, LLC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
203-419-4420
First Name & Middle Initial & Last Name & Degree
Joseph Soufer
Facility Name
Suncoast Research Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
3056316704
First Name & Middle Initial & Last Name & Degree
Mark Eliot Kutner
Facility Name
North Georgia Clinical Research
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
678-494-5735
First Name & Middle Initial & Last Name & Degree
Bram Wieskopf
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
312-503-2315
First Name & Middle Initial & Last Name & Degree
Thomas Schnitzer
Facility Name
MedVadis Research Corporation
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
617-744-1310
First Name & Middle Initial & Last Name & Degree
David DiBenedetto
Facility Name
Great Lakes Research Group, Inc.
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48706
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
989-895-9100
First Name & Middle Initial & Last Name & Degree
Jeffrey A. Potts
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
4178837889
First Name & Middle Initial & Last Name & Degree
David Gregory True
Facility Name
Mercy Family Clinic
City
Dallas
State/Province
Texas
ZIP/Postal Code
75211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ebere Israel Azubuike, MD
Facility Name
Clinical Trials of Texas, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
2109490122
First Name & Middle Initial & Last Name & Degree
Douglas Scott Denham
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
425-453-0404
First Name & Middle Initial & Last Name & Degree
Nazia Rahman
Facility Name
Paratus Clinical Research Canberra
City
Bruce
State/Province
Australian Capital Territory
ZIP/Postal Code
2617
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amber Leah
Facility Name
Optimus Clinical Research
City
Botany
State/Province
New South Wales
ZIP/Postal Code
2019
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Bird
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
61736468111
First Name & Middle Initial & Last Name & Degree
Donald Soutter Alexander McLeod
Facility Name
Core Research Group
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4064
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
61738765688
First Name & Middle Initial & Last Name & Degree
David Martin Colquhoun
Facility Name
Coastal Digestive Health
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
0754080900
First Name & Middle Initial & Last Name & Degree
Hansjoerg Seltenreich
Facility Name
Emeritus Research
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
Phone
0395096166
First Name & Middle Initial & Last Name & Degree
King Chou Cheung
Facility Name
Barwon Health
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon McCarthy
Facility Name
C-health Research
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 4J2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
4037053636
First Name & Middle Initial & Last Name & Degree
Sue Pedersen
Facility Name
Viable Clinical Research
City
Bridgewater
State/Province
Nova Scotia
ZIP/Postal Code
B4V 3N2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel DuToit
Facility Name
Wharton Medical Clinic
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sean Wharton
Facility Name
Bluewater Clinical Research Group Inc.
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
15193446612
First Name & Middle Initial & Last Name & Degree
John Charles O'Mahony
Facility Name
Viable Clinical Research
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1P 2T7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Butt
Facility Name
Stouffville Medical Centre
City
Stouffville
State/Province
Ontario
ZIP/Postal Code
L4A 1H2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
9056403100
First Name & Middle Initial & Last Name & Degree
Douglas Wu
Facility Name
Canadian Phase Onward
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J 0K2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lew Pliamm
Facility Name
Alpha Recherche Clinique
City
Quebec
ZIP/Postal Code
G2J 0C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
4187041112
First Name & Middle Initial & Last Name & Degree
Raphael Poulin-Robitaille
Facility Name
ALPHA Recherche Clinique
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
Phone
4188471112
First Name & Middle Initial & Last Name & Degree
Xavier Mignault
Facility Name
Consultorio Médico
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44210
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
523315237659
First Name & Middle Initial & Last Name & Degree
Armando Rafael Vargas
Facility Name
IMED Internal Medicine Clin Trials
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64060
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
8183470078
First Name & Middle Initial & Last Name & Degree
Jose Angel Garza Ruiz
Facility Name
Clínica García Flores SC
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64610
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
Phone
528183482015
First Name & Middle Initial & Last Name & Degree
Pedro Alberto Garcia
Facility Name
Unidad Médica para la Salud Integral
City
San Nicolás de los Garza
State/Province
Nuevo León
ZIP/Postal Code
66465
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
52818348897
First Name & Middle Initial & Last Name & Degree
Ramiro Guadalupe Banda Elizondo
Facility Name
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares
City
Ciudad Madero
State/Province
Tamaulipas
ZIP/Postal Code
89440
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
52183312600
First Name & Middle Initial & Last Name & Degree
Rafael Margarito Violante Ortiz
Facility Name
Kohler and Milstein Research S.A. de C.V.
City
Mérida
State/Province
Yucatán
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Abraham Simon Campos
Facility Name
Investigacion y Biomedicina de Chihuahua
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
526144373003
First Name & Middle Initial & Last Name & Degree
Cesar Francisco Pacheco-Tena
Facility Name
CHUAC-Complejo Hospitalario Universitario A Coruña
City
A Coruña
State/Province
A Coruña [La Coruña]
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
655624017
First Name & Middle Initial & Last Name & Degree
Alfonso Soto Gonzalez
Facility Name
Hospital General Universitario de Valencia
City
Valencia
State/Province
Valenciana, Comunitat
ZIP/Postal Code
46014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
9631318004
First Name & Middle Initial & Last Name & Degree
Juan Carlos Ferrer Garcia
Facility Name
Hospital Quirón Málaga
City
Málaga
ZIP/Postal Code
29004
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34684054019
First Name & Middle Initial & Last Name & Degree
Jose Manuel Garcia Almeida
Facility Name
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
City
Sevilla
ZIP/Postal Code
41003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
Phone
34954709183
First Name & Middle Initial & Last Name & Degree
Alberto Aliaga Verdugo
Facility Name
Leicester General Hospital
City
Leicester
State/Province
Leicestershire
ZIP/Postal Code
LE5 4PW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
Phone
01162588554
First Name & Middle Initial & Last Name & Degree
Melanie Davies
Facility Name
Panthera Biopartners - North London
City
Enfield
State/Province
London, City Of
ZIP/Postal Code
EN3 4GS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony A Avornyo
Facility Name
Panthera Biopartners - Sheffield
City
Sheffield
ZIP/Postal Code
S2 5FX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivelin Trifonov
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lilly.com/en-US/trial/408355
Description
A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee (TRIUMPH-4)
Learn more about this trial
A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
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