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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07037433
Registration number
NCT07037433
Ethics application status
Date submitted
16/06/2025
Date registered
25/06/2025
Date last updated
11/09/2025
Titles & IDs
Public title
Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
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Scientific title
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity
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Secondary ID [1]
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20220196
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Universal Trial Number (UTN)
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Trial acronym
MARITIME-CV
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atherosclerotic Cardiovascular Disease
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Overweight
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Obesity
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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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 - Maridebart Cafraglutide
Treatment: Drugs - Placebo
Experimental: Maridebart Cafraglutide - Participants will receive maridebart cafraglutide subcutaneously (SC).
Placebo comparator: Placebo - Participants will receive placebo SC.
Treatment: Drugs: Maridebart Cafraglutide
Maridebart cafraglutide will be administered SC.
Treatment: Drugs: Placebo
Placebo will be 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 a Composite Endpoint Consisting of: CV Death, Myocardial Infarction (MI), or Ischemic Stroke (3-point Major Adverse Cardiac Events [3-P MACE])
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Assessment method [1]
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Timepoint [1]
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Up to approximately 35 months
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Primary outcome [2]
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Time to First Occurrence of a Composite Endpoint Consisting of: All-cause Death, MI, Ischemic Stroke, Coronary Revascularization, or Heart Failure (HF) Event (5-point MACE)
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Assessment method [2]
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Timepoint [2]
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Up to approximately 35 months
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Secondary outcome [1]
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Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or HF Event
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Assessment method [1]
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Timepoint [1]
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Up to approximately 35 months
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Secondary outcome [2]
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Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke or Coronary Revascularization
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Assessment method [2]
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Timepoint [2]
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Up to approximately 35 months
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Secondary outcome [3]
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Time to First MI
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Assessment method [3]
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Timepoint [3]
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Up to approximately 35 months
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Secondary outcome [4]
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Time to First Ischemic Stroke
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Assessment method [4]
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Timepoint [4]
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Up to approximately 35 months
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Secondary outcome [5]
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Time to CV Death
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Assessment method [5]
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Timepoint [5]
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Up to approximately 35 months
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Secondary outcome [6]
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Time to All-cause Death
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Assessment method [6]
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Timepoint [6]
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Up to approximately 35 months
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Secondary outcome [7]
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Time to First Coronary Revascularization
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Assessment method [7]
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Timepoint [7]
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Up to approximately 35 months
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Secondary outcome [8]
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Time to First HF Event
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Assessment method [8]
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Timepoint [8]
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Up to approximately 35 months
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Secondary outcome [9]
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Time to First HF Event or CV Death
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Assessment method [9]
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0
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Timepoint [9]
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Up to approximately 35 months
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Secondary outcome [10]
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Time to First Unstable Angina Requiring Hospitalization
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Assessment method [10]
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0
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Timepoint [10]
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Up to approximately 35 months
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Secondary outcome [11]
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Time to First Occurrence of MI or CV Death
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Assessment method [11]
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0
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Timepoint [11]
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Up to approximately 35 months
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Secondary outcome [12]
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Time to First Occurrence of MI, Ischemic Stroke or All-cause Death
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Assessment method [12]
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0
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Timepoint [12]
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Up to approximately 35 months
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Secondary outcome [13]
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Total Major Ischemic Events (Time to First and Recurrent MI or Ischemic Stroke)
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Assessment method [13]
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0
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Timepoint [13]
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Up to approximately 35 months
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Secondary outcome [14]
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Total All-cause Hospitalizations (Time to First and Recurrent Event)
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Assessment method [14]
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Timepoint [14]
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Up to approximately 35 months
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Secondary outcome [15]
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Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes at Baseline
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Assessment method [15]
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Timepoint [15]
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Up to approximately 35 months
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Secondary outcome [16]
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Time to Onset of T2DM in Participants without T2DM at Baseline
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Assessment method [16]
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0
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Timepoint [16]
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Up to approximately 35 months
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Secondary outcome [17]
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Change from Baseline in Systolic Blood Pressure (SBP) at Week 72
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Assessment method [17]
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Timepoint [17]
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Baseline and Week 72
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Secondary outcome [18]
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Change from Baseline in Diastolic Blood Pressure (DBP) at Week 72
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Assessment method [18]
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Timepoint [18]
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Baseline and Week 72
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Secondary outcome [19]
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Change from Baseline in Body Mass Index (BMI) at Week 72
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Assessment method [19]
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Timepoint [19]
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Baseline and Week 72
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Secondary outcome [20]
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Change from Baseline in Waist Circumference at Week 72
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Assessment method [20]
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0
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Timepoint [20]
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Baseline and Week 72
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Secondary outcome [21]
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Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72
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Assessment method [21]
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0
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Timepoint [21]
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Baseline and Week 72
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Secondary outcome [22]
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Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
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Assessment method [22]
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Timepoint [22]
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Baseline and Week 72
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Secondary outcome [23]
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Change from Baseline in Fasting Plasma Glucose at Week 72
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Assessment method [23]
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Timepoint [23]
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Baseline and Week 72
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Secondary outcome [24]
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Percent Change from Baseline in High-sensitivity C-reactive protein (hs-CRP) at Week 72
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Assessment method [24]
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Timepoint [24]
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Baseline and Week 72
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Secondary outcome [25]
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Percent Change from Baseline in Body Weight at Week 72
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Assessment method [25]
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Timepoint [25]
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Baseline and Week 72
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Secondary outcome [26]
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Percent Change from Baseline in Total Cholesterol at Week 72
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Assessment method [26]
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Timepoint [26]
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Baseline and Week 72
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Secondary outcome [27]
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Percent Change from Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Week 72
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Assessment method [27]
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Timepoint [27]
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Baseline and Week 72
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Secondary outcome [28]
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Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 72
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Assessment method [28]
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Timepoint [28]
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Baseline and Week 72
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Secondary outcome [29]
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Percent Change from Baseline in Triglycerides (TG) at Week 72
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Assessment method [29]
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Timepoint [29]
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Baseline and Week 72
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Secondary outcome [30]
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Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants with T2DM at Baseline
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Assessment method [30]
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Timepoint [30]
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Baseline and Week 72
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Secondary outcome [31]
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Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants with T2DM at Baseline
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Assessment method [31]
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0
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Timepoint [31]
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Baseline and Week 72
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Secondary outcome [32]
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Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with T2DM at Baseline
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Assessment method [32]
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0
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Timepoint [32]
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Baseline and Week 72
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Secondary outcome [33]
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Number of Participants at Week 72 with HbA1c < 6.5% (48 mmol/mol) in Participants Without T2DM at Baseline
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Assessment method [33]
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0
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Timepoint [33]
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Baseline and Week 72
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Secondary outcome [34]
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Number of Participants at Week 72 with HbA1c < 6.0% (42 mmol/mol) in Participants Without T2DM at Baseline
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Assessment method [34]
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0
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Timepoint [34]
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0
Baseline and Week 72
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Secondary outcome [35]
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Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants Without T2DM at Baseline
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Assessment method [35]
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0
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Timepoint [35]
0
0
Baseline and Week 72
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Secondary outcome [36]
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Number of Participants at Week 72 with HbA1c < 5.7% (39 mmol/mol) in Participants with HbA1c = 5.7% and < 6.5% at Baseline
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Assessment method [36]
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0
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Timepoint [36]
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Baseline and Week 72
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Secondary outcome [37]
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Change from Baseline in Short Form 36 Health Survey Acute Version 2 (SF-36 v2) Physical Function Domain Score at Week 48
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Assessment method [37]
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Timepoint [37]
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Baseline and Week 48
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Secondary outcome [38]
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Time to First Event of a Composite Nephropathy Endpoint
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Assessment method [38]
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Composite endpoint consists of onset of persistent macroalbuminuria, persistent = 40% reduction in estimated glomerular filtration rate (eGFR), onset of persistent eGFR \< 15 mL/min/1.73 m2, initiation of chronic renal replacement therapy (dialysis or transplantation), CV or renal death.
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Timepoint [38]
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Up to approximately 35 months
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Secondary outcome [39]
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Change in eGFR (total slope) for the period from baseline to the final follow up visit
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Assessment method [39]
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Timepoint [39]
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Baseline up to approximately 35 months
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Secondary outcome [40]
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Change in eGFR (chronic slope) for the period from 4 months to the final follow-up visit
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Assessment method [40]
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Timepoint [40]
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From 4 months up to approximately 35 months
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Secondary outcome [41]
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Time to First Occurrence of a Major Adverse Limb Event (MALE) Defined as Acute Limb Ischemia, Urgent Peripheral Revascularization, Major Amputation Due to a Vascular Etiology or Chronic Limb-threatening Ischemia Requiring Revascularization
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Assessment method [41]
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Timepoint [41]
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Up to approximately 35 months
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Secondary outcome [42]
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Total Arterial (Coronary, Cerebrovascular, and Peripheral) Revascularization Procedures (Time to First and Recurrent Event)
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Assessment method [42]
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Timepoint [42]
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Up to approximately 35 months
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Secondary outcome [43]
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Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, MALE, or Arterial Revascularization
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Assessment method [43]
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0
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Timepoint [43]
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Up to approximately 35 months
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Secondary outcome [44]
0
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Time to First Occurrence of a Composite Endpoint Consisting of: CV Death, MI, Ischemic Stroke, or Acute Limb Ischemia
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Assessment method [44]
0
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Timepoint [44]
0
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Up to approximately 35 months
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Secondary outcome [45]
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Time to First Occurrence of a Composite Endpoint Consisting of CV Death, MI, Ischemic Stroke, Acute Limb Ischemia, or Urgent Arterial Revascularization Procedure (Coronary, Cerebrovascular or Peripheral)
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Assessment method [45]
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0
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Timepoint [45]
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Up to approximately 35 months
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Secondary outcome [46]
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Number of Participants with Treatment-emergent Adverse Events
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Assessment method [46]
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Timepoint [46]
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Up to approximately 35 months
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Secondary outcome [47]
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Number of Participants with Serious Adverse Events
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Assessment method [47]
0
0
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Timepoint [47]
0
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Up to approximately 35 months
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Secondary outcome [48]
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Plasma Concentration of Maridebart Cafraglutide at Week 72
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Assessment method [48]
0
0
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Timepoint [48]
0
0
Week 72
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Eligibility
Key inclusion criteria
Inclusion Criteria
* Age = 45 years at screening.
* BMI of = 27 kg/m2 at screening.
* History of Atherosclerotic Cardiovascular Disease (ASCVD) as evidenced by at least one of the following:
* Prior MI.
* Prior ischemic stroke (may include ischemic stroke with hemorrhagic transformation).
* Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) < 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.
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Minimum age
45
Years
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Maximum age
99
Years
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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
Exclusion Criteria
* History of any of the following within 60 days before screening: MI, hospitalization for unstable angina, coronary artery revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke, or transient ischemic attack (TIA).
* New York Heart Association (NYHA) class IV HF at screening or hospitalization for HF within 60 days before screening.
* Type 1 DM, or any type of diabetes with the exception of T2DM or history of gestational diabetes.
* For participants with a prior diagnosis of T2DM at screening:
* HbA1c > 10.0% (86 mmol/mol) at screening.
* History of diabetic ketoacidosis or hyperosmolar state/coma within 12 months before screening.
* One or more episodes of severe hypoglycemia within 6 months before screening and/or history of hypoglycemia unawareness.
* History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
* Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the study.
* History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening.
* Family (first-degree relative[s]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2).
* Calcitonin = 50 ng/L (pg/mL) at screening.
* Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) > 3.0 x the upper limit of normal (ULN), or total bilirubin (TBL) > 1.8 x ULN (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL).
* History of malignancy within the last 5 years before screening (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ).
* Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.
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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
25/07/2025
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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
29/09/2030
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Actual
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Sample size
Target
12800
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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0
Barwon Health Geelong Hospital - Geelong
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Recruitment hospital [2]
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0
Advara HeartCare Joondalup - Joondalup
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Recruitment postcode(s) [1]
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0
3220 - Geelong
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Recruitment postcode(s) [2]
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0
6027 - Joondalup
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Delaware
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Florida
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Georgia
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Idaho
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Illinois
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Indiana
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Iowa
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Kansas
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Kentucky
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Louisiana
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Maryland
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Massachusetts
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Country [16]
0
0
United States of America
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State/province [16]
0
0
Minnesota
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Country [17]
0
0
United States of America
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State/province [17]
0
0
Missouri
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Nebraska
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Nevada
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Country [20]
0
0
United States of America
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State/province [20]
0
0
New York
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Country [21]
0
0
United States of America
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State/province [21]
0
0
North Carolina
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Country [22]
0
0
United States of America
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State/province [22]
0
0
Ohio
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Country [23]
0
0
United States of America
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State/province [23]
0
0
Oklahoma
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Country [24]
0
0
United States of America
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State/province [24]
0
0
Pennsylvania
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Country [25]
0
0
United States of America
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State/province [25]
0
0
Rhode Island
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Country [26]
0
0
United States of America
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State/province [26]
0
0
South Dakota
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Country [27]
0
0
United States of America
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State/province [27]
0
0
Tennessee
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Country [28]
0
0
United States of America
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State/province [28]
0
0
Texas
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Country [29]
0
0
United States of America
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State/province [29]
0
0
Utah
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Country [30]
0
0
United States of America
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State/province [30]
0
0
Washington
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Country [31]
0
0
United States of America
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State/province [31]
0
0
West Virginia
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Country [32]
0
0
United States of America
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State/province [32]
0
0
Wisconsin
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Country [33]
0
0
Japan
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State/province [33]
0
0
Hokkaido
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Country [34]
0
0
Japan
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State/province [34]
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0
Kagawa-ken
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Country [35]
0
0
Japan
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State/province [35]
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0
Oita Prefecture
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Country [36]
0
0
Japan
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State/province [36]
0
0
Shizuoka
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Country [37]
0
0
Japan
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State/province [37]
0
0
Tokyo
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Country [38]
0
0
Japan
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State/province [38]
0
0
Tottori
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Country [39]
0
0
Japan
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State/province [39]
0
0
Yamaguchi
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Country [40]
0
0
Puerto Rico
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State/province [40]
0
0
Ponce
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.
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Trial website
https://clinicaltrials.gov/study/NCT07037433
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
MD
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Address
0
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Amgen
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Amgen Call Center
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866-572-6436
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[email protected]
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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?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
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Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
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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://www.amgen.com/datasharing
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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/NCT07037433
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