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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05882045
Registration number
NCT05882045
Ethics application status
Date submitted
22/05/2023
Date registered
31/05/2023
Date last updated
28/05/2024
Titles & IDs
Public title
A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
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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
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Secondary ID [1]
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0
J1I-MC-GZBM
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Secondary ID [2]
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0
18582
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Universal Trial Number (UTN)
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Trial acronym
TRIUMPH-3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
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Cardiovascular Diseases
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Condition category
Condition code
Diet and Nutrition
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0
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0
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Obesity
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Metabolic and Endocrine
0
0
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0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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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
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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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Percent Change from Baseline in Body Weight
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Assessment method [1]
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Timepoint [1]
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Baseline, Week 80
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Secondary outcome [1]
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Change from Baseline in Body Mass Index (BMI)
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Assessment method [1]
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Timepoint [1]
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Baseline, Week 80
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Secondary outcome [2]
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Change from Baseline in Waist Circumference
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Assessment method [2]
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Timepoint [2]
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Baseline, Week 80
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Secondary outcome [3]
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Percent Change from Baseline in Total Cholesterol
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Assessment method [3]
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Timepoint [3]
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Baseline, Week 80
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Secondary outcome [4]
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Percent Change from Baseline in Triglycerides
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Assessment method [4]
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Timepoint [4]
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Baseline, Week 80
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Secondary outcome [5]
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Change from Baseline in Systolic Blood Pressure (SBP)
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Assessment method [5]
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Timepoint [5]
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Baseline, Week 80
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Secondary outcome [6]
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Change from Baseline in Diastolic Blood Pressure (DBP)
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Assessment method [6]
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Timepoint [6]
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Baseline, Week 80
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Secondary outcome [7]
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Change from Baseline in Hemoglobin A1c (HbA1c)
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Assessment method [7]
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Timepoint [7]
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Baseline, Week 80
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Secondary outcome [8]
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Percent Change from Baseline in Fasting Insulin
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Assessment method [8]
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Timepoint [8]
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Baseline, Week 80
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Secondary outcome [9]
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Change from Baseline in Short Form version 2 (SF-36v2) Acute Form Physical Function Domain Score
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Assessment method [9]
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Timepoint [9]
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Baseline, Week 80
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Secondary outcome [10]
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Pharmacokinetics (PK): Steady State Area Under the Concentration Time Cure (AUC)
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Assessment method [10]
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AUC is presented as a single average measure of AUC across the study duration.
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Timepoint [10]
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Baseline to Week 80
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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.
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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 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.
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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
The people analysing the results/data
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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
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
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Actual
30/05/2023
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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
17/02/2026
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Actual
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Sample size
Target
1800
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,South AustVIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Canberra
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Recruitment hospital [2]
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Optimus Clinical Research - Botany
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Northern Beaches Clinical Research - Brookvale
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Camden Hospital - Camden
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The AIM Centre / Hunter Diabetes Centre - Merewether
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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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Core Research Group - Brisbane
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Coastal Digestive Health - Maroochydore
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Logan Hospital - Meadowbrook
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Fusion Clinical Research - Adelaide
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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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Recruitment postcode(s) [1]
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2605 - Canberra
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Recruitment postcode(s) [2]
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2019 - Botany
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Recruitment postcode(s) [3]
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2100 - Brookvale
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2570 - Camden
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2291 - Merewether
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2006 - Sydney
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4029 - Brisbane
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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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Recruitment postcode(s) [18]
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6009 - Nedlands
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Recruitment outside Australia
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Valenciana, Comunitat
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Madrid
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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 this study is to evaluate the efficacy and safety of retatrutide once
weekly in participants with obesity and established cardiovascular disease (CVD). The study
will last about 113 weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05882045
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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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Address
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Eli Lilly and Company
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Email
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Contact person for public queries
Name
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There may be multiple sites in this clinical trial -877-CTLILLY (1-877-285-4559) or
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Address
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Phone
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1-317-615-4559
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05882045
Download to PDF