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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05882045




Registration number
NCT05882045
Ethics application status
Date submitted
22/05/2023
Date registered
31/05/2023

Titles & IDs
Public title
A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
Scientific title
A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants With Severe Obesity and Established Cardiovascular Disease
Secondary ID [1] 0 0
J1I-MC-GZBM
Secondary ID [2] 0 0
18582
Universal Trial Number (UTN)
Trial acronym
TRIUMPH-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 0 0
Cardiovascular Diseases 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

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
Incidence of all adverse events (AEs)
Timepoint [1] 0 0
Up to 12 weeks after last dose of study treatment
Primary outcome [2] 0 0
Percent Change from Baseline in Body Weight
Timepoint [2] 0 0
Baseline, Week 80
Secondary outcome [1] 0 0
Change from Baseline in Body Mass Index (BMI)
Timepoint [1] 0 0
Baseline, Week 80
Secondary outcome [2] 0 0
Change from Baseline in Waist Circumference
Timepoint [2] 0 0
Baseline, Week 80
Secondary outcome [3] 0 0
Percent Change from Baseline in Total Cholesterol
Timepoint [3] 0 0
Baseline, Week 80
Secondary outcome [4] 0 0
Percent Change from Baseline in Triglycerides
Timepoint [4] 0 0
Baseline, Week 80
Secondary outcome [5] 0 0
Change from Baseline in Systolic Blood Pressure (SBP)
Timepoint [5] 0 0
Baseline, Week 80
Secondary outcome [6] 0 0
Change from Baseline in Diastolic Blood Pressure (DBP)
Timepoint [6] 0 0
Baseline, Week 80
Secondary outcome [7] 0 0
Change from Baseline in Hemoglobin A1c (HbA1c)
Timepoint [7] 0 0
Baseline, Week 80
Secondary outcome [8] 0 0
Percent Change from Baseline in Fasting Insulin
Timepoint [8] 0 0
Baseline, Week 80
Secondary outcome [9] 0 0
Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score
Timepoint [9] 0 0
Baseline, Week 80
Secondary outcome [10] 0 0
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC)
Timepoint [10] 0 0
Baseline to Week 80

Eligibility
Key inclusion criteria
* Have a body mass index (BMI) =35.0 kilogram/square meter (kg/m²).
* Have established cardiovascular (CV) disease with at least 1 of the following:

* prior myocardial infarction
* prior ischemic or hemorrhagic stroke, or
* symptomatic peripheral arterial disease
* Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have had acute myocardial infarction, stroke, coronary revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure within 90 days prior to screening.
* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a prior or planned surgical treatment of obesity.
* Have a change in body weight greater than 5 kg (11 pounds) within 90 days prior to screening.
* Have Type 1 diabetes.
* Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
* Have had pancreatitis.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/02/2026
Actual
Sample size
Target
1800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,South AustVIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Emeritus Research - Botany
Recruitment hospital [3] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [4] 0 0
The AIM Centre / Hunter Diabetes Centre - Merewether
Recruitment hospital [5] 0 0
University of Sydney - Charles Perkins Centre - Sydney
Recruitment hospital [6] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [7] 0 0
Core Research Group - Brisbane
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CDH Research Institute - Maroochydore
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Logan Hospital - Meadowbrook
Recruitment hospital [10] 0 0
Fusion Clinical Research - Adelaide
Recruitment hospital [11] 0 0
Southern Adelaide Diabetes & Endocrine Services - Mount Gambier
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Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
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Nightingale Research - Adelaide
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Box Hill Hospital - Box Hill
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Emeritus Research - Camberwell
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Barwon Health - Geelong
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Austin Health - Repatriation Hospital - Heidelberg West
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One Clinical Research - Nedlands
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Flinders Medical Centre - Bedford Park
Recruitment hospital [20] 0 0
TrialsWest Pty Ltd - Spearwood
Recruitment postcode(s) [1] 0 0
2605 - Canberra
Recruitment postcode(s) [2] 0 0
2019 - Botany
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2100 - Brookvale
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2291 - Merewether
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2006 - Sydney
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4029 - Brisbane
Recruitment postcode(s) [7] 0 0
4064 - Brisbane
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4558 - Maroochydore
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4131 - Meadowbrook
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5000 - Adelaide
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5290 - Mount Gambier
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5046 - Oaklands Park
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3128 - Box Hill
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3124 - Camberwell
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3220 - Geelong
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3081 - Heidelberg West
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6009 - Nedlands
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5042 - Bedford Park
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6163 - Spearwood
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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 -877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
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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/NCT05882045