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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06383390




Registration number
NCT06383390
Ethics application status
Date submitted
22/04/2024
Date registered
25/04/2024

Titles & IDs
Public title
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Event-Driven Study to Investigate the Effect of Retatrutide on the Incidence of Major Adverse Cardiovascular Events and Major Adverse Kidney Events in Participants With Body Mass Index =27 kg/m2 and Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease
Secondary ID [1] 0 0
J1I-MC-GZBO
Secondary ID [2] 0 0
18584
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease (ASCVD) 0 0
Chronic Kidney Disease (CKD) 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

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

Experimental: Retatrutide - Participants will receive escalated doses of retatrutide administered subcutaneously (SC) up to a maximum tolerated dose.

Placebo comparator: Placebo - Participants will receive matching placebo administered SC.


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
Time to First Occurrence of Composite Endpoints
Timepoint [1] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Primary outcome [2] 0 0
Time to First Occurrence of Composite Endpoint of End Stage Kidney Disease (ESKD), = 40% Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), CV Death or Renal Death
Timepoint [2] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary outcome [1] 0 0
Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3)
Timepoint [1] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary outcome [2] 0 0
Time to First Occurrence of Composite Endpoint of CV death, or hospitalization or urgent visit due to HF
Timepoint [2] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary outcome [3] 0 0
Time to Occurrence of All-Cause Death
Timepoint [3] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary outcome [4] 0 0
Time to First Occurrence of composite endpoint of = 40% Sustained Decline in eGFR, End-Stage Renal Disease (ESRD), or Renal Death
Timepoint [4] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)
Secondary outcome [5] 0 0
Percentage change from Baseline in Albuminuria urinary albumin/creatinine ratio (UACR) in Participants with UACR =30 mg/g (0.03 mg/mg) at baseline
Timepoint [5] 0 0
Randomization up to Study Completion (Approximate 248 Weeks)

Eligibility
Key inclusion criteria
* Participants may be without type 2 diabetes (T2D), or with T2D if their hemoglobin A1c (HbA1c) is 10% or lower
* Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following:

* Coronary artery disease
* Cerebrovascular disease
* Peripheral arterial disease
* Chronic kidney disease defined as:

* eGFR <45 millilitres/minute/1.73 meter squared (mL/min/1.73m^2) and UACR >30 milligram/gram (mg/g) (0.030 mg/mg)
* eGFR <60 mL/min/1.73 m^2 and UACR >100 mg/g (0.100 mg/mg), or
* eGFR <75 mL/min/1.73 m^2 and UACR >300 mg/g (0.300 mg/mg) (eGFR is calculated by central lab based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine-cystatin c equation as determined by central lab)
* A Body Mass Index of =27.0 kilograms per meter squared (kg/m^2)
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diabetes related:

* Participants have Type 1 Diabetes or any history of diabetic ketoacidosis

CV related:

* Participants have any of the following cardiovascular conditions = 90 days prior to randomization:

* Myocardial infarction
* Acute coronary syndrome
* Stroke, or
* Coronary, peripheral, or carotid artery arterial revascularization procedure.
* Have acute decompensated heart failure requiring hospitalization.
* Have New York Heart Association (NYHA) Classification Class IV heart failure at screening

Kidney related:

* Participants have an eGFR <20 mL/min/1.73 m^2 at screening
* Have UACR >5000 mg/g (5.000 mg/mg) at screening
* Have received any form of dialysis = 90 days from the date of randomization
* Have either undergone a kidney transplant or have a transplant procedure scheduled

Other medical conditions:

* Participants have had or plan to have a surgical treatment for obesity,
* Have a history of chronic or acute pancreatitis
* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome type 2
* Have a known clinically significant gastric emptying abnormality, such as severe gastroparesis or gastric outlet obstruction

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
30/04/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2029
Actual
Sample size
Target
10000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Canberra Hospital - Garran
Recruitment hospital [2] 0 0
Emeritus Research - Botany
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Northern Beaches Clinical Research - Brookvale
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The AIM Centre / Hunter Diabetes Centre - Merewether
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Royal North Shore Hospital - St Leonards
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University of Sydney - Charles Perkins Centre - Sydney
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Royal Brisbane and Women's Hospital - Brisbane
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Logan Hospital - Meadowbrook
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Nightingale Research - Adelaide
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Southern Adelaide Diabetes & Endocrine Services - Oaklands Park
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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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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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2605 - Garran
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2019 - Botany
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2100 - Brookvale
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2291 - Merewether
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2065 - St Leonards
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2006 - Sydney
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4029 - Brisbane
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4131 - Meadowbrook
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5000 - Adelaide
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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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3004 - Melbourne
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6150 - Murdoch
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Mexico
State/province [191] 0 0
Puebla
Country [192] 0 0
Mexico
State/province [192] 0 0
San Luis Potosí
Country [193] 0 0
Netherlands
State/province [193] 0 0
Drenthe
Country [194] 0 0
Netherlands
State/province [194] 0 0
Flevoland
Country [195] 0 0
Netherlands
State/province [195] 0 0
Fryslân
Country [196] 0 0
Netherlands
State/province [196] 0 0
Gelderland
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Netherlands
State/province [197] 0 0
Limburg
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Netherlands
State/province [198] 0 0
Noord-Brabant
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Netherlands
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Noord-Holland
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Netherlands
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Overijssel
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Netherlands
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Utrecht
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Netherlands
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Zuid-Holland
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Netherlands
State/province [203] 0 0
Den Haag
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Netherlands
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Poland
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Dolnoslaskie
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Poland
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Poland
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Poland
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Mazowieckie
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Poland
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Malopolskie
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Poland
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Opolskie
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Poland
State/province [211] 0 0
Podkarpackie
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Podlaskie
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Poland
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Pomorskie
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Poland
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Warminsko-mazurskie
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Poland
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Wielkopolskie
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Poland
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Lódzkie
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Poland
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Slaskie
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Bayamón
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Puerto Rico
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Ponce
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Puerto Rico
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San Juan
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Bra?ov
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Bucure?ti
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Dolj
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Maramure?
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Romania
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Mure?
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Romania
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Timi?
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Ia?i
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Sibiu
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Slovakia
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Trnavský Kraj
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Slovakia
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Žilinský Kraj
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Spain
State/province [237] 0 0
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Spain
State/province [238] 0 0
Almería
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Spain
State/province [239] 0 0
Andalucía
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Spain
State/province [240] 0 0
Asturias, Principado De
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Spain
State/province [241] 0 0
Balears [Baleares]
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Spain
State/province [242] 0 0
Barcelona [Barcelona]
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Spain
State/province [243] 0 0
Cantabria
Country [244] 0 0
Spain
State/province [244] 0 0
Madrid
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Spain
State/province [245] 0 0
Sevilla
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Spain
State/province [246] 0 0
Valenciana, Comunitat
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Spain
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València
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Turkey
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Bursa
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Turkey
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Eskisehir
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kocaeli
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Turkey
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Adana
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Turkey
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Afyonkarahisar
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Corum
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Turkey
State/province [258] 0 0
Edirne
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Turkey
State/province [259] 0 0
Gaziantep
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Turkey
State/province [260] 0 0
Kayseri
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Turkey
State/province [261] 0 0
Konya
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Turkey
State/province [262] 0 0
Kütahya
Country [263] 0 0
Turkey
State/province [263] 0 0
Mersin
Country [264] 0 0
Turkey
State/province [264] 0 0
Sivas
Country [265] 0 0
Ukraine
State/province [265] 0 0
Chernihivska Oblast
Country [266] 0 0
Ukraine
State/province [266] 0 0
Kyivska Oblast
Country [267] 0 0
Ukraine
State/province [267] 0 0
Kyiv
Country [268] 0 0
Ukraine
State/province [268] 0 0
Vinnytska Oblast
Country [269] 0 0
Ukraine
State/province [269] 0 0
Zhytomyrska Oblast
Country [270] 0 0
Ukraine
State/province [270] 0 0
Lviv
Country [271] 0 0
United Kingdom
State/province [271] 0 0
Aberdeen City
Country [272] 0 0
United Kingdom
State/province [272] 0 0
Cornwall
Country [273] 0 0
United Kingdom
State/province [273] 0 0
England
Country [274] 0 0
United Kingdom
State/province [274] 0 0
Kingston Upon Hull
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United Kingdom
State/province [275] 0 0
Somerset
Country [276] 0 0
United Kingdom
State/province [276] 0 0
Suffolk
Country [277] 0 0
United Kingdom
State/province [277] 0 0
Swansea [Abertawe Gb-ata]
Country [278] 0 0
United Kingdom
State/province [278] 0 0
Wirral
Country [279] 0 0
United Kingdom
State/province [279] 0 0
Birmingham
Country [280] 0 0
United Kingdom
State/province [280] 0 0
Coventry

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
ClinicalTrials.gov@lilly.com
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?
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/NCT06383390