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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04788511
Registration number
NCT04788511
Ethics application status
Date submitted
5/03/2021
Date registered
9/03/2021
Titles & IDs
Public title
Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
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Scientific title
Effect of Semaglutide 2.4 mg Once Weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction
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Secondary ID [1]
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U1111-1243-4358
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Secondary ID [2]
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EX9536-4665
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Universal Trial Number (UTN)
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Trial acronym
STEP-HFpEF
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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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0
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Condition category
Condition code
Cardiovascular
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0
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Coronary heart disease
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Cardiovascular
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0
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Other cardiovascular diseases
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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
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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 - Semaglutide
Treatment: Drugs - Placebo (semaglutide)
Experimental: Semaglutide - All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
Placebo comparator: Placebo (semaglutide) - All participants will receive either semaglutide 2.4 mg once weekly or placebo once weekly as add-on to standard of care. During the first 16 weeks, the dose of semaglutide or placebo will be gradually escalated from 0.25 mg once weekly until target dose.
Treatment: Drugs: Semaglutide
Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial.
Dose gradually escalated from 0.25 mg until target dose. The study will last for approximately 59 weeks.
Treatment: Drugs: Placebo (semaglutide)
Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial.
The study will last for approximately 59 weeks.
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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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Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
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Assessment method [1]
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The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [1]
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From baseline (week 0) to end of treatment (week 52)
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Primary outcome [2]
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Change in Body Weight
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Assessment method [2]
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Change in body weight from baseline (week 0) to end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [2]
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From baseline (week 0) to end of treatment (week 52)
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Secondary outcome [1]
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Change in Six-minute Walking Distance (6MWD)
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Assessment method [1]
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Observed mean change from baseline (week 0) in 6 minutes walking distance (6MWD) test to end of treatment (week 52) is presented. The 6MWD is a common test of functional exercise capacity that assesses the distance a participant can walk in 6 minutes. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [1]
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From baseline (week 0) to end of treatment (week 52)
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Secondary outcome [2]
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The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs
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Assessment method [2]
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The hierarchical composite outcome measure from baseline (week 0) to end of study (week 57) consists of the components: time to all-cause death, number of heart failure events requiring hospitalization or urgent heart failure visit, time to first heart failure event requiring hospitalization or urgent heart failure visit, difference at least 15 in KCCQ CSS change from baseline to 52 weeks, difference at least 10 in KCCQ CSS change from baseline to 52 weeks, difference at least 5 in KCCQ CSS change from baseline to 52 weeks and difference at least 30 meters in six-minute walking distance change from baseline to 52 weeks. It was analyzed by the win-ratio approach using all participants pairs across treatment groups. Overall summary of wins in each treatment group is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [2]
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From baseline (week 0) to end of study (week 57)
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Secondary outcome [3]
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Change in C-Reactive Protein (CRP): Ratio to Baseline
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Assessment method [3]
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Change in high sensitivity C-reactive protein measured in ratio of C-reactive protein to baseline (week -2) at end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [3]
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From baseline (week -2) to end of treatment (week 52)
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Secondary outcome [4]
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Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No)
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Assessment method [4]
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Percentage of participants who achieved 10% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 10% weight loss whereas 'No' infers percentage of participants who have not achieved 10% weight loss. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [4]
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From baseline (week 0) to end of treatment (week 52)
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Secondary outcome [5]
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Percentage of Participants Achieving 15% Weight Loss (Yes/No)
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Assessment method [5]
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Percentage of participants who achieved 15% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 15% weight loss whereas 'No' infers percentage of participants who have not achieved 15% weight loss. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [5]
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From baseline (week 0) to end of treatment (week 52)
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Secondary outcome [6]
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Percentage of Participants Achieving 20% Weight Loss (Yes/No)
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Assessment method [6]
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Percentage of participants who achieved 20% weight loss (yes/no) from baseline (week 0) to end of treatment (week 52) is presented. In the reported data, 'Yes' infers percentage of participants who have achieved 20% weight loss whereas 'No' infers percentage of participants who have not achieved 20% weight loss The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [6]
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From baseline (week 0) to end of treatment (week 52)
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Secondary outcome [7]
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Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No)
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Assessment method [7]
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Percentage of participants improving 5 points or more in KCCQ-CSS from baseline to end of treatment is presented. The KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms(frequency, severity, and recent change), physical limitation, quality of life, and social limitation. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. In the reported data, 'Yes' infers percentage of participants who have improved 5 points or more in score whereas 'No' infers percentage of participants who have not improved 5 points or more in score. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [7]
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From baseline (week 0) to end of treatment (week 52)
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Secondary outcome [8]
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Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No)
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Assessment method [8]
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Percentage of participants improving 10 points or more in KCCQ-CSS from baseline to end of treatment is presented. The KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms(frequency, severity, and recent change), physical limitation, quality of life, and social limitation. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. In reported data, 'Yes' infers percentage of participants who have improved 5 points or more in score whereas 'No' infers percentage of participants who have not improved 10 points or more in score. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [8]
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From baseline (week 0) to end of treatment (week 52)
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Secondary outcome [9]
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Change in KCCQ Overall Summary Score (KCCQ-OSS)
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Assessment method [9]
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The KCCQ is a standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. The overall summary score and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes the symptom and physical limitation domains of the KCCQ while KCCQ-OSS includes the symptom, physical limitation, quality of life, and social limitation domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [9]
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From baseline (week 0) to end of treatment (week 52)
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Secondary outcome [10]
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Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S)
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Assessment method [10]
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The patient global impression of status (PGI-S) for KCCQ was used to rate participants' symptoms of heart failure using 4-category ordinal scale (no symptoms, mild, moderate, severe). KCCQ is standardized 23-item, self-administered instrument that quantifies heart failure symptoms (frequency, severity, and recent change), physical limitation, quality of life, and social limitation. OSS and all domains have been independently demonstrated to be valid, reliable, and responsive to clinical change. KCCQ-CSS includes symptom and physical limitation domains of the KCCQ. Scores are transformed to range of 0-100, in which higher scores reflect better health status. Outcome measure was evaluated based on data from in-trial period. In-trial period was defined as uninterrupted time interval from date of randomization to date of last contact with trial site. The threshold was defined as mean change in KCCQ-CSS in those participants with one-category improvement in PGI-S from baseline to week 52.
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Timepoint [10]
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From baseline (week 0) to end of treatment (week 52)
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Secondary outcome [11]
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Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in 6MWD (PGI-S)
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Assessment method [11]
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Observed mean change from baseline in 6 minutes walking distance (6MWD) test using PGI-S is evaluated for this outcome measure. The 6MWD is a common test of functional exercise capacity that assesses the distance a participant can walk in 6 minutes. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site. The threshold was defined as the mean change in 6MWD in those participants with an one-category improvement in PGI-S from baseline to week 52.
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Timepoint [11]
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From baseline (week 0) to end of treatment (week 52)
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Secondary outcome [12]
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Change in Systolic Blood Pressure (SBP)
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Assessment method [12]
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Observed mean change in systolic blood pressure from baseline (week -2) to end of treatment (week 52) is presented. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [12]
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From baseline (week -2) to end of treatment (week 52)
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Secondary outcome [13]
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Change in Waist Circumference
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Assessment method [13]
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Change waist circumference from baseline (week 0) to end of the treatment (visit 52) presented. Waist circumference is defined as the abdominal circumference located midway between the lower rib margin and the iliac crest. Measurement must be obtained in standing position with a non-stretchable measuring tape and to the nearest cm or inch. The tape should touch the skin but not compress soft tissue and twists in the tape should be avoided. The participant should be asked to breathe normally. The same measuring tape should be used throughout the trial. The outcome measure was evaluated based on the data from in-trial period. In-trial period was defined as the uninterrupted time interval from date of randomization to date of last contact with trial site.
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Timepoint [13]
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From baseline (week 0) to end of treatment (visit 52)
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Eligibility
Key inclusion criteria
* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Body mass index (BMI) greater than or equal to 30.0 kg/m^2
* New York Heart Association (NYHA) Class II-IV
* Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records
* Haemoglobin A1c (HbA1c) greater than or equal to 6.5 percentage (48 mmol/mol) based on latest available value from medical records, no older than 3 months or if unavailable a local measurement at screening
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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
Completed
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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
16/03/2021
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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
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Actual
18/04/2023
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Sample size
Target
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Accrual to date
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Final
529
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA,VIC
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Recruitment hospital [1]
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The Canberra Hospital_Garran - Garran
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Recruitment hospital [2]
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Concord Repatriation General Hospital - Cardiology - Concord
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Recruitment hospital [3]
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Liverpool Hospital - Liverpool
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Recruitment hospital [4]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [5]
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Geelong Cardiology Research Unit - Geelong
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2139 - Concord
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Recruitment postcode(s) [3]
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2170 - Liverpool
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Recruitment postcode(s) [4]
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5042 - Bedford Park
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Recruitment postcode(s) [5]
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3220 - Geelong
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Illinois
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Kansas
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Kentucky
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Louisiana
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Maryland
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Minnesota
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Missouri
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New York
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North Carolina
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Ohio
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Pennsylvania
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Texas
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Argentina
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Buenos Aires
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Argentina
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Caba
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Argentina
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Ciudad Autónoma de Buenos Aire
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Argentina
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Corrientes
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Morón
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Argentina
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Rosario, Santa Fe
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Ontario
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Czechia
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Jihlava
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Czechia
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Praha 2
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Praha 7
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Slany
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Tábor
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Aarhus N
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Svendborg
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Berlin
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Germany
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Dresden
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Germany
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Elsterwerda
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Kassel
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Würzburg
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Bács-Kiskun Vármegye
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Hungary
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Komárom-Esztergom
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Budapest
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Israel
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Jerusalem
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Israel
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Nahariya
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Israel
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Petah-Tikva
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Israel
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Tel Aviv
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Israel
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Tel Hashomer
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Netherlands
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Apeldoorn
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Beverwijk
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Groningen
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Hardenberg
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Roosendaal
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Poland
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Lodzkie
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Malopolskie
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Podlaskie
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Poland
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Gdynia
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Poland
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Warsaw
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Poland
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Slaskie
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Spain
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Madrid
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Spain
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Santiago de Compostela
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Spain
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Valencia
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United Kingdom
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Bristol
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United Kingdom
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Dundee
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United Kingdom
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Glasgow
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Country [66]
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United Kingdom
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State/province [66]
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High Wycombe
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United Kingdom
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Liverpool
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United Kingdom
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Manchester
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United Kingdom
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Swindon
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United Kingdom
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West Sussex
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novo Nordisk A/S
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Ethics approval
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Summary
Brief summary
This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study. This is to compare the effect on heart failure symptoms and on body weight in people taking semaglutide (a new medicine) to people taking "dummy" medicine. Participants will either get semaglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm. During the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity. The study will last for approximately 59 weeks. Participants will have 11 clinic visits and 1 phone call with the study doctor. Women: Women cannot take part if they are pregnant, breast-feeding or plan to become pregnant during the study period.
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Trial website
https://clinicaltrials.gov/study/NCT04788511
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Trial related presentations / publications
Borlaug BA, Kitzman DW, Davies MJ, Rasmussen S, Barros E, Butler J, Einfeldt MN, Hovingh GK, Moller DV, Petrie MC, Shah SJ, Verma S, Abhayaratna W, Ahmed FZ, Chopra V, Ezekowitz J, Fu M, Ito H, Lelonek M, Melenovsky V, Nunez J, Perna E, Schou M, Senni M, van der Meer P, Von Lewinski D, Wolf D, Kosiborod MN. Semaglutide in HFpEF across obesity class and by body weight reduction: a prespecified analysis of the STEP-HFpEF trial. Nat Med. 2023 Sep;29(9):2358-2365. doi: 10.1038/s41591-023-02526-x. Epub 2023 Aug 27. Kosiborod MN, Abildstrom SZ, Borlaug BA, Butler J, Rasmussen S, Davies M, Hovingh GK, Kitzman DW, Lindegaard ML, Moller DV, Shah SJ, Treppendahl MB, Verma S, Abhayaratna W, Ahmed FZ, Chopra V, Ezekowitz J, Fu M, Ito H, Lelonek M, Melenovsky V, Merkely B, Nunez J, Perna E, Schou M, Senni M, Sharma K, Van der Meer P, von Lewinski D, Wolf D, Petrie MC; STEP-HFpEF Trial Committees and Investigators. Semaglutide in Patients with Heart Failure with Preserved Ejection Fraction and Obesity. N Engl J Med. 2023 Sep 21;389(12):1069-1084. doi: 10.1056/NEJMoa2306963. Epub 2023 Aug 25.
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Public notes
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Contacts
Principal investigator
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Clinical Transparency (dept. 1452)
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Novo Nordisk A/S
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Contact person for public queries
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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?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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When will data be available (start and end dates)?
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Available to whom?
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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://novonordisk-trials.com
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/11/NCT04788511/Prot_002.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/11/NCT04788511/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Kosiborod MN, Abildstrom SZ, Borlaug BA, Butler J,...
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Results not provided in
https://clinicaltrials.gov/study/NCT04788511