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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05931367




Registration number
NCT05931367
Ethics application status
Date submitted
27/06/2023
Date registered
5/07/2023

Titles & IDs
Public title
A Study of Retatrutide (LY3437943) Once Weekly in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
Scientific 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
Secondary ID [1] 0 0
J1I-MC-GZBN
Secondary ID [2] 0 0
18583
Universal Trial Number (UTN)
Trial acronym
TRIUMPH-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Overweight 0 0
Osteo Arthritis Knee 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Retatrutide
Treatment: Drugs - Placebo

Experimental: Retatrutide Dose 1 - Participants will receive retatrutide subcutaneously (SC).

Experimental: Retatrutide Dose 2 - Participants will receive retatrutide SC.

Placebo comparator: Placebo - Participants will receive placebo.


Treatment: Drugs: Retatrutide
Administered SC

Treatment: Drugs: Placebo
Administered SC
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
Timepoint [1] 0 0
Baseline, Week 68
Primary outcome [2] 0 0
Percent Change from Baseline in Body Weight
Timepoint [2] 0 0
Baseline, Week 68
Secondary outcome [1] 0 0
Change from Baseline in the WOMAC Physical Function Subscale Score
Timepoint [1] 0 0
Baseline, Week 68
Secondary outcome [2] 0 0
Change from Baseline in Waist Circumference
Timepoint [2] 0 0
Baseline, Week 68
Secondary outcome [3] 0 0
Percent Change from Baseline in Total Cholesterol
Timepoint [3] 0 0
Baseline, Week 68
Secondary outcome [4] 0 0
Percent Change from Baseline in Triglycerides
Timepoint [4] 0 0
Baseline, Week 68
Secondary outcome [5] 0 0
Change from Baseline in Body Mass Index (BMI)
Timepoint [5] 0 0
Baseline, Week 68
Secondary outcome [6] 0 0
Change from Baseline in Systolic Blood Pressure (SBP)
Timepoint [6] 0 0
Baseline, Week 68
Secondary outcome [7] 0 0
Change from Baseline in Diastolic Blood Pressure (DBP)
Timepoint [7] 0 0
Baseline, Week 68
Secondary outcome [8] 0 0
Percent Change from Baseline in Fasting Insulin
Timepoint [8] 0 0
Baseline, Week 68
Secondary outcome [9] 0 0
Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score
Timepoint [9] 0 0
Baseline, Week 68
Secondary outcome [10] 0 0
Change from Baseline in Average Pain Intensity Numeric Rating Score (API-NRS) Score
Timepoint [10] 0 0
Baseline, Week 68
Secondary outcome [11] 0 0
Change from Baseline in Worst Pain Intensity Numeric Rating Score (WPI-NRS) Score
Timepoint [11] 0 0
Baseline, Week 68

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/03/2026
Actual
Sample size
Target
405
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [3] 0 0
Emeritus Research - Botany
Recruitment hospital [4] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [5] 0 0
Core Research Group - Brisbane
Recruitment hospital [6] 0 0
CDH Research Institute - Maroochydore
Recruitment hospital [7] 0 0
Emeritus Research - Camberwell
Recruitment hospital [8] 0 0
Barwon Health - Geelong
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2019 - Botany
Recruitment postcode(s) [4] 0 0
4029 - Brisbane
Recruitment postcode(s) [5] 0 0
4064 - Brisbane
Recruitment postcode(s) [6] 0 0
4558 - Maroochydore
Recruitment postcode(s) [7] 0 0
3124 - Camberwell
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
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United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Idaho
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
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United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
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Canada
State/province [13] 0 0
Alberta
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Canada
State/province [14] 0 0
Newfoundland and Labrador
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Mexico
State/province [18] 0 0
Jalisco
Country [19] 0 0
Mexico
State/province [19] 0 0
Nuevo León
Country [20] 0 0
Mexico
State/province [20] 0 0
Tamaulipas
Country [21] 0 0
Mexico
State/province [21] 0 0
Yucatán
Country [22] 0 0
Mexico
State/province [22] 0 0
Chihuahua
Country [23] 0 0
Spain
State/province [23] 0 0
A Coruña [La Coruña]
Country [24] 0 0
Spain
State/province [24] 0 0
Andalucía
Country [25] 0 0
Spain
State/province [25] 0 0
Catalunya [Cataluña]
Country [26] 0 0
Spain
State/province [26] 0 0
Madrid, Comunidad De
Country [27] 0 0
Spain
State/province [27] 0 0
Valenciana, Comunitat
Country [28] 0 0
Spain
State/province [28] 0 0
Sevilla
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Leicestershire
Country [30] 0 0
United Kingdom
State/province [30] 0 0
London, City Of
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05931367