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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07037459
Registration number
NCT07037459
Ethics application status
Date submitted
16/06/2025
Date registered
25/06/2025
Date last updated
11/09/2025
Titles & IDs
Public title
Maridebart Cafraglutide in Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity
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Scientific title
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)
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Secondary ID [1]
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20230227
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Universal Trial Number (UTN)
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Trial acronym
MARITIME-HF
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Preserved Ejection Fraction
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Heart Failure With Mildly Reduced Ejection Fraction
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Obesity
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Condition category
Condition code
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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Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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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 or HF Events
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Assessment method [1]
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Heart Failure events include: hospitalization for HF or urgent HF visits.
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Timepoint [1]
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Up to approximately 35 months
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Secondary outcome [1]
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Change From Baseline in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS) for Participants with Baseline KCCQ-CSS Score = 80
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Assessment method [1]
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The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
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Timepoint [1]
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Baseline and Week 48
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Secondary outcome [2]
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Change from Baseline in the KCCQ Total Symptom Score (TSS) for Participants with Baseline KCCQ-CSS Score = 80
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Assessment method [2]
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The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
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Timepoint [2]
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Baseline and Week 48
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Secondary outcome [3]
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Total Number of HF Events Including First and Recurrent HF Events
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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 Occurrence of a Composite Endpoint Consisting of: Myocardial Infarction (MI), Ischemic Stroke, CV Death (Major Adverse Cardiac Events), or HF Events
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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 First Event of a Composite Nephropathy Endpoint
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Assessment method [5]
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The composite nephropathy endpoint consists of: persistent macroalbuminuria, persistent = 40% reduction in estimated glomerular filtration rate (eGFR), onset of persistent eGFR \< 15 mL/min/1.73 m\^2, initiation of chronic renal replacement therapy (dialysis or transplantation), CV or renal death.
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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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Change in eGFR Slope (Total)
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Assessment method [6]
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Timepoint [6]
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Baseline up to approximately 35 months
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Secondary outcome [7]
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Change in eGFR Slope (Chronic)
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Assessment method [7]
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Timepoint [7]
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From 4 months up to approximately 35 months
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Secondary outcome [8]
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Time to Onset of Type 2 Diabetes Mellitus (T2DM) in Participants with Prediabetes
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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 the First HF Event
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Assessment method [9]
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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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Change from Baseline in the Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
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Assessment method [10]
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Timepoint [10]
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Baseline and Week 72
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Secondary outcome [11]
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Change from Baseline in the Waist Circumference (cm)
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Assessment method [11]
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Timepoint [11]
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Baseline and Week 72
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Secondary outcome [12]
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Change from Baseline in the Urine Albumin-to-creatinine Ratio (uACR)
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Assessment method [12]
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Timepoint [12]
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Baseline and Week 72
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Secondary outcome [13]
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Change from Baseline in the Hemoglobin A1c (HbA1c [%, mmol/mol]) in Participants with T2DM
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Assessment method [13]
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Timepoint [13]
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Baseline and Week 72
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Secondary outcome [14]
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Percent Change from Baseline in the High-sensitivity C Reactive Protein (hs-CRP)
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Assessment method [14]
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0
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Timepoint [14]
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Baseline and Week 72
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Secondary outcome [15]
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Percent Change from Baseline in the Body Weight (kg)
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Assessment method [15]
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Timepoint [15]
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Baseline and Week 72
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Secondary outcome [16]
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Percent Change from Baseline in Total Cholesterol
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Assessment method [16]
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Timepoint [16]
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Baseline and Week 72
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Secondary outcome [17]
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Percent Change from Baseline in Non-high-density Lipoprotein Cholesterol (non-HDL-C)
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Assessment method [17]
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0
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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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Percent Change from Baseline in Low-density Lipoprotein Cholesterol (LDL-C), HDL-C, Triglycerides (TG), Very Low-density Lipoprotein Cholesterol (VLDL-C)
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Assessment method [18]
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0
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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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Total All-cause Hospitalizations (First and Recurrent Time to Event)
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Assessment method [19]
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Timepoint [19]
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Up to approximately 35 months
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Secondary outcome [20]
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Number of Participants Achieving = 5-point Change in KCCQ-CSS Score from Baseline for Participants with Baseline KCCQ-CSS Score = 80
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Assessment method [20]
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The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
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Timepoint [20]
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Baseline and Week 48
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Secondary outcome [21]
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Number of Participants Achieving = 10-point Change in KCCQ-CSS Score from Baseline for Participants with Baseline KCCQ-CSS Score = 80
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Assessment method [21]
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The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
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Timepoint [21]
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Baseline and Week 48
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Secondary outcome [22]
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Number of Participants Achieving an Anchor-based Change in KCCQ-CSS Score From Baseline for Participants with Baseline KCCQ-CSS Score = 80
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Assessment method [22]
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The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Change (PGI-C) can be used as anchors to estimate within-patient change in the KCCQ-CSS score.
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Timepoint [22]
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Baseline and Week 48
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Secondary outcome [23]
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Number of Participants Achieving = 5-point Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score = 80
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Assessment method [23]
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The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
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Timepoint [23]
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0
Baseline and Week 48
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Secondary outcome [24]
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Number of Participants Achieving = 10-point Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score = 80
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Assessment method [24]
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0
The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life.
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Timepoint [24]
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0
Baseline and Week 48
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Secondary outcome [25]
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Number of Participants Achieving an Anchor-based Change in KCCQ-TSS Score from Baseline for Participants with Baseline KCCQ-CSS Score = 80
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Assessment method [25]
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0
The KCCQ is a 23-item disease-specific measure for participants with HF, measuring the participant's perception of their health status. The KCCQ-TSS assesses symptom frequency and burden, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The KCCQ-CSS assesses symptoms and physical limitations, ranging from 0 to 100, with higher scores indicating better functioning and quality of life. The PGI-S and PGI-C can be used as anchors to estimate within-patient change in the KCCQ-CSS score.
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Timepoint [25]
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Baseline and Week 48
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Secondary outcome [26]
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Time to All-cause Death
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Assessment method [26]
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0
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Timepoint [26]
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Up to approximately 35 months
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Secondary outcome [27]
0
0
Time to CV Death
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Assessment method [27]
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0
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Timepoint [27]
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Up to Approximately 35 Months
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Secondary outcome [28]
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Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events
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Assessment method [28]
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0
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Timepoint [28]
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Up to approximately 35 months
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Secondary outcome [29]
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Plasma Concentration of Maridebart Cafraglutide
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Assessment method [29]
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Timepoint [29]
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Week 72
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Secondary outcome [30]
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Change from Baseline in N-terminal Pro B Type Natriuretic Peptide (NT-proBNP)
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Assessment method [30]
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0
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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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Time to New Onset of Atrial Fibrillation (AF) or Atrial Flutter (AFL) in Participants Without a History of AF or AFL at Baseline
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Assessment method [31]
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Timepoint [31]
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Baseline and up to approximately 35 months
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Eligibility
Key inclusion criteria
* Age = 18 years.
* BMI = 30 kg/m^2.
* HF diagnosed for at least 30 days before screening with New York Heart Association (NYHA) Class II-IV.
* Managed with HF standard of care therapies.
* Left ventricular ejection fraction (LVEF) of > 40%.
* Elevated NT-proBNP.
* Participants must have at least one of the following:
1. Structural heart disease OR
2. Documented hospitalization with a primary diagnosis of decompensated HF within 12 months before randomization OR
3. Evidence of elevated filling pressures within 12 months before randomization.
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Minimum age
18
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
* History of any of the following within 60 days before screening: Type I (spontaneous) MI, valvular replacement or repair, coronary revascularization, coronary artery bypass graft surgery or other major cardiovascular surgery, stroke.
* HF due to: hypertrophic cardiomyopathy, infiltrative cardiomyopathy, active myocarditis, constrictive pericarditis, cardiac tamponade, arrhythmogenic right ventricular or left ventricular cardiomyopathy/dysplasia, or uncorrected primary valvular heart disease, or clinically significant congenital heart disease.
* Any lifetime history of LVEF = 40%.
* Currently hospitalized with acute decompensated HF or hospitalization with a primary diagnosis of decompensated HF within 30 days before screening.
* Type 1 diabetes mellitus, 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:
1. HbA1c > 10.0%
2. Uncontrolled diabetes requiring immediate therapy
3. History of diabetic ketoacidosis or hyperosmolar state/coma
4. One or more episodes of severe hypoglycemia within 6 months before screening and/or history of hypoglycemia unawareness
5. History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
* SBP = 180 mmHg , or on three or more blood pressure-lowering drugs with a SBP > 160 mmHg.
* History of chronic pancreatitis or acute pancreatitis in the 180 days before screening.
* Family (or personal) history of medullary thyroid carcinoma or MEN-2.
* eGFR < 20 mL/min/1.73 m^2 (CKD-EPI creatinine (Cr)-cystatin C equation) or receiving dialysis at screening.
* Calcitonin = 50 ng/L (pg/mL) at screening.
* Acute or chronic hepatitis.
* Any of the following psychiatric history:
1. History of unstable major depressive disorder or other severe psychiatric disorder within 2 years before screening
2. Lifetime history of suicide attempt
3. History of non-suicidal self-injury within 5 years before screening.
* History of any other condition that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the study.
* 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.
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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
25/06/2025
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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
5056
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Sydney Cardiometabolic Centre - Liverpool
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Recruitment hospital [2]
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Advara HeartCare Wesley - Auchenflower
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Recruitment hospital [3]
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Core Research Group Pty Ltd - Milton
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Recruitment hospital [4]
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Dr Heart Pty Ltd - Woolloongabba
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Recruitment postcode(s) [1]
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2170 - Liverpool
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Recruitment postcode(s) [2]
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4066 - Auchenflower
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Recruitment postcode(s) [3]
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4064 - Milton
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
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Alabama
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Country [2]
0
0
United States of America
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State/province [2]
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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
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Idaho
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Illinois
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Indiana
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Kansas
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Kentucky
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Louisiana
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Maryland
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Michigan
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Country [14]
0
0
United States of America
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State/province [14]
0
0
Minnesota
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Country [15]
0
0
United States of America
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State/province [15]
0
0
Nebraska
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Country [16]
0
0
United States of America
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State/province [16]
0
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New York
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Country [17]
0
0
United States of America
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State/province [17]
0
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Pennsylvania
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Country [18]
0
0
United States of America
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State/province [18]
0
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South Dakota
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Country [19]
0
0
United States of America
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State/province [19]
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Tennessee
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Country [20]
0
0
United States of America
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Texas
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Country [21]
0
0
United States of America
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State/province [21]
0
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Virginia
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Country [22]
0
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Canada
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State/province [22]
0
0
Manitoba
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Country [23]
0
0
Canada
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State/province [23]
0
0
Ontario
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Country [24]
0
0
Japan
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State/province [24]
0
0
Hokkaido
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Country [25]
0
0
Japan
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State/province [25]
0
0
Kagawa-ken
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Country [26]
0
0
Japan
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State/province [26]
0
0
Kanagawa
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Country [27]
0
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Japan
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State/province [27]
0
0
Kumamoto
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Country [28]
0
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Japan
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State/province [28]
0
0
Oita Prefecture
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Country [29]
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Japan
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State/province [29]
0
0
Shizuoka
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Country [30]
0
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Japan
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State/province [30]
0
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Tokyo
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Country [31]
0
0
Japan
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State/province [31]
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Tottori
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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
This study will examine if maridebart cafraglutide as an adjunct to standard of care will lead to a reduction in heart failure (HF) events such as HF hospitalizations and urgent HF visits, cardiovascular (CV) deaths and improvement in HF symptoms in participants with HF with preserved ejection fraction (HFpEF) and HF with mildly reduced ejection fraction (HFmrEF) who are obese. This is a phase 3, global, multicenter, 2-part study with a double-blind period and an open-label extension (OLE). The study is event-driven, and Part 1 will conclude when approximately 850 primary endpoint events have occurred.
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Trial website
https://clinicaltrials.gov/study/NCT07037459
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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
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Amgen
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Country
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0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
Amgen Call Center
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Address
0
0
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Country
0
0
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Phone
0
0
866-572-6436
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Fax
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0
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Email
0
0
[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?
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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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: http://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/NCT07037459
Download to PDF