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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07165028
Registration number
NCT07165028
Ethics application status
Date submitted
28/08/2025
Date registered
10/09/2025
Date last updated
10/09/2025
Titles & IDs
Public title
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
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Scientific title
A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes
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Secondary ID [1]
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2025-522674-36-00
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Secondary ID [2]
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27610
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metabolic Dysfunction-Associated Steatotic Liver Disease
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Condition category
Condition code
Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
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Metabolic disorders
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Diet and Nutrition
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tirzepatide
Treatment: Drugs - Retatrutide
Treatment: Drugs - Placebo
Experimental: Tirzepatide (TZ01) - Participants will receive tirzepatide subcutaneously (SC)
Placebo comparator: Placebo (TZ01) - Participants will receive placebo SC
Experimental: Retatrutide (RT01) - Participants will receive retatrutide SC
Placebo comparator: Placebo (RT01) - Participants will receive placebo SC
Treatment: Drugs: Tirzepatide
Administered SC
Treatment: Drugs: Retatrutide
Administered SC
Treatment: Drugs: Placebo
Administered SC
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Time to First Occurrence of Any Component of the Composite Endpoint for Major Adverse Liver Outcomes (MALO)
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Assessment method [1]
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Composite endpoint comprised of progression to cirrhosis, development of large esophageal varices, gastric varices or development of varices needing treatment, development of ascites, development of hepatic encephalopathy, evidence of active or recent variceal hemorrhage, increase in model for end-stage liver disease (MELD) from =12 to =15, liver transplantation, all-cause mortality
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Timepoint [1]
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Baseline up to Study Completion (about 224 weeks)
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Secondary outcome [1]
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Change from Baseline in Enhanced Liver Fibrosis (ELF) Score
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Assessment method [1]
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Timepoint [1]
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Baseline, Week 104
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Secondary outcome [2]
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Change from Baseline in Vibration-Controlled Transient Elastography Liver Stiffness Measurement (VCTE LSM)
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Assessment method [2]
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Timepoint [2]
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Baseline, Week 104
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Secondary outcome [3]
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Percent Change from Baseline in Liver Fat Content (LFC)
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Assessment method [3]
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Timepoint [3]
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Baseline, Week 104
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Secondary outcome [4]
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Time to Occurrence of Progression to Cirrhosis
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Assessment method [4]
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Timepoint [4]
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Baseline up to Study Completion (about 224 weeks)
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Secondary outcome [5]
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Change from Baseline in Aspartate Aminotransferase (AST)
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Assessment method [5]
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0
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Timepoint [5]
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Baseline, Study Completion (about 224 weeks)
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Secondary outcome [6]
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Change from Baseline in Alanine Aminotransferase (ALT)
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Assessment method [6]
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Timepoint [6]
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Baseline, Study Completion (about 224 weeks)
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Secondary outcome [7]
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Change from Baseline in Body Weight
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Assessment method [7]
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Timepoint [7]
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Baseline, Study Completion (about 224 weeks)
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Secondary outcome [8]
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Change from Baseline in Non-Alcoholic Steatohepatitis-CHECK Score (NASH-CHECK)
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Assessment method [8]
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Timepoint [8]
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Baseline, Week 104
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Secondary outcome [9]
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Time to First Occurrence of Any Component Event of the Composite Endpoint of Major Adverse Cardiovascular Events (MACE-3)
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Assessment method [9]
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MACE-3 composite endpoint includes nonfatal myocardial infarction, nonfatal stroke, cardiovascular death
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Timepoint [9]
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Baseline up to Study Completion (about 224 weeks)
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Eligibility
Key inclusion criteria
* Have liver fat content =8%
* Have ELF score of =9 and =10.8 at screening
* Have VCTE LSM =10 kilopascal (kPa) and <20 kPa at screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Have any other type of liver disease other than MASLD
* Have a body mass index (BMI) <25 kilogram per square meter (kg/m2)
* Prior decompensated liver disease (history of esophageal/gastric varices, ascites, hepatic encephalopathy)
* Have lost more than 11 pounds within the 3 months prior to screening
* Have a hemoglobin A1c (HbA1c) greater than 10%
* Have type 1 diabetes
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
1/12/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2032
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Actual
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Sample size
Target
4500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Nightingale Research - Adelaide
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Recruitment hospital [2]
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Core Research Group - Brisbane
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Ipswich Hospital - Ipswich
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Recruitment hospital [4]
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Gold Coast University Hospital - Southport
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Recruitment hospital [5]
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Westmead Hospital - Westmead
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5000 - Adelaide
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Recruitment postcode(s) [2]
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4064 - Brisbane
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Recruitment postcode(s) [3]
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4305 - Ipswich
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Recruitment postcode(s) [4]
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4215 - Southport
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Recruitment postcode(s) [5]
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2145 - Westmead
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Recruitment outside Australia
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United States of America
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Arizona
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Lille
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Spain
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Ferrol
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Spain
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Huelva
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Spain
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Madrid
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0
Spain
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Palma
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Spain
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Pontevedra
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Spain
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Santander
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Spain
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Seville
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Spain
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Valencia
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Sweden
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Linköping
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Taiwan
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Taipei
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Ukraine
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Ivano-Frankivsk
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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State/province [141]
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Vinnytsia
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Ukraine
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Zhytomyr
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United Kingdom
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Clifton
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United Kingdom
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Enfield
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The main purpose of the SYNERGY-OUTCOMES study is to find out whether retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in people with high-risk metabolic dysfunction-associated steatotic liver disease (MASLD). The study will enroll adults who have MASLD based on non-invasive tests (NITs), which indicate they are more likely to develop MALO. Participants will be randomly assigned within a Master Protocol to receive either retatrutide (N1T-MC-RT01), tirzepatide (N1T-MC-TZ01) or placebo. The trial plans to enroll about 4,500 adults and will run for approximately 224 weeks. Participants may have up to approximately 25 to 30 clinic visits throughout the study to monitor their health, complete study procedures, and assess liver function and disease progression. Once the study is complete, eligible participants may participate in an optional 2-year extension study, in which all participants will receive either retatrutide or tirzepatide, even if they received placebo in the main study.
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Trial website
https://clinicaltrials.gov/study/NCT07165028
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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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)
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Eli Lilly and Company
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Contact person for public queries
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There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
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Phone
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1-317-615-4559
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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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)
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When will data be available (start and end dates)?
Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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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/NCT07165028
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