{"protocolSection":{"identificationModule":{"nctId":"NCT04788511","orgStudyIdInfo":{"id":"EX9536-4665"},"secondaryIdInfos":[{"id":"U1111-1243-4358","type":"OTHER","domain":"World Health Organization (WHO)"},{"id":"2019-004452-11","type":"REGISTRY","domain":"European Medicines Agency (EudraCT)"},{"id":"2019","type":"NIH","link":"https://reporter.nih.gov/quickSearch/2019"}],"organization":{"fullName":"Novo Nordisk A/S","class":"INDUSTRY"},"briefTitle":"Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity","officialTitle":"Effect of Semaglutide 2.4 mg Once Weekly on Function and Symptoms in Subjects With Obesity-related Heart Failure With Preserved Ejection Fraction","acronym":"STEP-HFpEF"},"statusModule":{"statusVerifiedDate":"2025-11","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2021-03-16","type":"ACTUAL"},"primaryCompletionDateStruct":{"date":"2023-04-18","type":"ACTUAL"},"completionDateStruct":{"date":"2023-04-18","type":"ACTUAL"},"studyFirstSubmitDate":"2021-03-05","studyFirstSubmitQcDate":"2021-03-05","studyFirstPostDateStruct":{"date":"2021-03-09","type":"ACTUAL"},"resultsFirstSubmitDate":"2024-04-18","resultsFirstSubmitQcDate":"2024-06-08","resultsFirstPostDateStruct":{"date":"2024-06-11","type":"ACTUAL"},"lastUpdateSubmitDate":"2025-11-30","lastUpdatePostDateStruct":{"date":"2025-12-05","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Novo Nordisk A/S","class":"INDUSTRY"}},"oversightModule":{"oversightHasDmc":false,"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"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.\n\nParticipants 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.\n\nDuring the study participants will have talks with the study staff about healthy lifestyle choices including healthy food and physical activity.\n\nThe 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."},"conditionsModule":{"conditions":["Obesity"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE3"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"DOUBLE","maskingDescription":"Sponsor staff involved in the clinical trial is masked according to company standard procedures.","whoMasked":["PARTICIPANT","INVESTIGATOR"]}},"enrollmentInfo":{"count":529,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Semaglutide","type":"EXPERIMENTAL","description":"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.","interventionNames":["Drug: Semaglutide"]},{"label":"Placebo (semaglutide)","type":"PLACEBO_COMPARATOR","description":"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.","interventionNames":["Drug: Placebo (semaglutide)"]}],"interventions":[{"type":"DRUG","name":"Semaglutide","description":"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.\n\nDose gradually escalated from 0.25 mg until target dose. The study will last for approximately 59 weeks.","armGroupLabels":["Semaglutide"]},{"type":"DRUG","name":"Placebo (semaglutide)","description":"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.\n\nThe study will last for approximately 59 weeks.","armGroupLabels":["Placebo (semaglutide)"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"},{"measure":"Change in Body Weight","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"}],"secondaryOutcomes":[{"measure":"Change in Six-minute Walking Distance (6MWD)","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"},{"measure":"The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs","description":"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.","timeFrame":"From baseline (week 0) to end of study (week 57)"},{"measure":"Change in C-Reactive Protein (CRP): Ratio to Baseline","description":"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.","timeFrame":"From baseline (week -2) to end of treatment (week 52)"},{"measure":"Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No)","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"},{"measure":"Percentage of Participants Achieving 15% Weight Loss (Yes/No)","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"},{"measure":"Percentage of Participants Achieving 20% Weight Loss (Yes/No)","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"},{"measure":"Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No)","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"},{"measure":"Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No)","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"},{"measure":"Change in KCCQ Overall Summary Score (KCCQ-OSS)","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"},{"measure":"Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S)","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"},{"measure":"Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in 6MWD (PGI-S)","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (week 52)"},{"measure":"Change in Systolic Blood Pressure (SBP)","description":"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.","timeFrame":"From baseline (week -2) to end of treatment (week 52)"},{"measure":"Change in Waist Circumference","description":"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.","timeFrame":"From baseline (week 0) to end of treatment (visit 52)"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Male or female, age above or equal to 18 years at the time of signing informed consent.\n* Body mass index (BMI) greater than or equal to 30.0 kg/m\\^2\n* New York Heart Association (NYHA) Class II-IV\n* Left ventricular ejection fraction (LVEF) greater than or equal to 45 percentage at screening\n\nExclusion Criteria:\n\n* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records\n* 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","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 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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."},{"pmid":"37622681","type":"RESULT","citation":"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."},{"pmid":"39222642","type":"DERIVED","citation":"Kosiborod MN, Deanfield J, Pratley R, Borlaug BA, Butler J, Davies MJ, Emerson SS, Kahn SE, Kitzman DW, Lingvay I, Mahaffey KW, Petrie MC, Plutzky J, Rasmussen S, Ronnback C, Shah SJ, Verma S, Weeke PE, Lincoff AM; SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM Trial Committees and Investigators. Semaglutide versus placebo in patients with heart failure and mildly reduced or preserved ejection fraction: a pooled analysis of the SELECT, FLOW, STEP-HFpEF, and STEP-HFpEF DM randomised trials. Lancet. 2024 Sep 7;404(10456):949-961. doi: 10.1016/S0140-6736(24)01643-X. Epub 2024 Aug 30."},{"pmid":"38739118","type":"DERIVED","citation":"Shah SJ, Sharma K, Borlaug BA, Butler J, Davies M, Kitzman DW, Petrie MC, Verma S, Patel S, Chinnakondepalli KM, Einfeldt MN, Jensen TJ, Rasmussen S, Asleh R, Ben-Gal T, Kosiborod MN. Semaglutide and diuretic use in obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF-DM trials. Eur Heart J. 2024 Sep 14;45(35):3254-3269. doi: 10.1093/eurheartj/ehae322."},{"pmid":"38599221","type":"DERIVED","citation":"Butler J, Shah SJ, Petrie MC, Borlaug BA, Abildstrom SZ, Davies MJ, Hovingh GK, Kitzman DW, Moller DV, Verma S, Einfeldt MN, Lindegaard ML, Rasmussen S, Abhayaratna W, Ahmed FZ, Ben-Gal T, Chopra V, Ezekowitz JA, 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, Kosiborod MN; STEP-HFpEF Trial Committees and Investigators. Semaglutide versus placebo in people with obesity-related heart failure with preserved ejection fraction: a pooled analysis of the STEP-HFpEF and STEP-HFpEF DM randomised trials. Lancet. 2024 Apr 27;403(10437):1635-1648. doi: 10.1016/S0140-6736(24)00469-0. Epub 2024 Apr 7."},{"pmid":"37993201","type":"DERIVED","citation":"Butler J, Abildstrom SZ, Borlaug BA, Davies MJ, Kitzman DW, Petrie MC, Shah SJ, Verma S, Abhayaratna WP, Chopra V, Ezekowitz JA, Fu M, Ito H, Lelonek M, Nunez J, Perna E, Schou M, Senni M, van der Meer P, von Lewinski D, Wolf D, Altschul RL, Rasmussen S, Kosiborod MN. Semaglutide in Patients With Obesity and Heart Failure Across Mildly Reduced or Preserved Ejection Fraction. J Am Coll Cardiol. 2023 Nov 28;82(22):2087-2096. doi: 10.1016/j.jacc.2023.09.811. Epub 2023 Oct 8."},{"pmid":"37952180","type":"DERIVED","citation":"Kosiborod MN, Verma S, Borlaug BA, Butler J, Davies MJ, Jon Jensen T, Rasmussen S, Erlang Marstrand P, Petrie MC, Shah SJ, Ito H, Schou M, Melenovsky V, Abhayaratna W, Kitzman DW; STEP-HFpEF Trial Committees and Investigators. Effects of Semaglutide on Symptoms, Function, and Quality of Life in Patients With Heart Failure With Preserved Ejection Fraction and Obesity: A Prespecified Analysis of the STEP-HFpEF Trial. Circulation. 2024 Jan 16;149(3):204-216. doi: 10.1161/CIRCULATIONAHA.123.067505. Epub 2023 Nov 12."}]},"ipdSharingStatementModule":{"ipdSharing":"YES","description":"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com","url":"http://novonordisk-trials.com"}},"resultsSection":{"participantFlowModule":{"recruitmentDetails":"The trial was conducted at 83 sites in 13 countries, as follows: Argentina (6), Australia (5), Hungary (8), Czech Republic (5), Poland (6), Spain (3), Netherlands (6), Denmark (3), United States (16), Canada (4), Israel (5), Germany (7) and United Kingdom (9).","groups":[{"id":"FG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (body mass index \\[BMI\\] greater than or equal to (≥) 30.0 kilogram per square meter (kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 milligrams (mg) once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"FG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"263"},{"groupId":"FG001","numSubjects":"266"}]},{"type":"Full Analysis Set (FAS)","achievements":[{"groupId":"FG000","numSubjects":"263"},{"groupId":"FG001","numSubjects":"266"}]},{"type":"Safety Analysis Set (SAS)","achievements":[{"groupId":"FG000","numSubjects":"263"},{"groupId":"FG001","numSubjects":"266"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"256"},{"groupId":"FG001","numSubjects":"254"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"},{"groupId":"FG001","numSubjects":"12"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"1"}]},{"type":"Lost to Follow-up","reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"Death","reasons":[{"groupId":"FG000","numSubjects":"3"},{"groupId":"FG001","numSubjects":"4"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Full analysis set (FAS) population included all the randomized participants for this trial.","groups":[{"id":"BG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"BG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"263"},{"groupId":"BG001","value":"266"},{"groupId":"BG002","value":"529"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"69","spread":"9"},{"groupId":"BG001","value":"68","spread":"10"},{"groupId":"BG002","value":"68","spread":"10"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"149"},{"groupId":"BG001","value":"148"},{"groupId":"BG002","value":"297"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"114"},{"groupId":"BG001","value":"118"},{"groupId":"BG002","value":"232"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"21"},{"groupId":"BG002","value":"36"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"248"},{"groupId":"BG001","value":"245"},{"groupId":"BG002","value":"493"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"8"},{"groupId":"BG001","value":"13"},{"groupId":"BG002","value":"21"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"255"},{"groupId":"BG001","value":"252"},{"groupId":"BG002","value":"507"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"243"},{"groupId":"OG001","value":"237"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.8","spread":"17.9"},{"groupId":"OG001","value":"10.3","spread":"17.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The responses at week 52 were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\\<35.0 kg/m\\^2, BMI\\>=35.0 kg/m\\^2) as factors and baseline KCCQ-CSS as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Estimated Treatment Difference","paramValue":"7.8","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"4.8","ciUpperLimit":"10.9"}]},{"type":"PRIMARY","title":"Change in Body Weight","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Percentage of body weight","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"242"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-13.9","spread":"8.1"},{"groupId":"OG001","value":"-2.5","spread":"5.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"groupDescription":"The responses were analyzed using an analysis of covariance model with randomized treatment and stratification (BMI\\<35.0 kg/m\\^2, BMI\\>=35.0 kg/m\\^2) as factors and baseline body weight (kg) as covariate. The analysis was based on the in-trial period using the FAS population. Missing observations at week 52 were multiple (x1000) imputed from retrieved participants of the same randomized treatment arm.","nonInferiorityType":"SUPERIORITY","pValue":"<0.0001","statisticalMethod":"ANCOVA","paramType":"Estimated Treatment Difference","paramValue":"-10.7","ciPctValue":"95","ciNumSides":"TWO_SIDED","ciLowerLimit":"-11.9","ciUpperLimit":"-9.4"}]},{"type":"SECONDARY","title":"Change in Six-minute Walking Distance (6MWD)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Meters","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"240"},{"groupId":"OG001","value":"225"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"23.5","spread":"59.2"},{"groupId":"OG001","value":"5.8","spread":"62.7"}]}]}]},{"type":"SECONDARY","title":"The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs","description":"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.","populationDescription":"FAS included all the randomized participants for this trial.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentages of wins of participant pairs","timeFrame":"From baseline (week 0) to end of study (week 57)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"263"},{"groupId":"OG001","value":"266"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"60.1"},{"groupId":"OG001","value":"34.9"}]}]}]},{"type":"SECONDARY","title":"Change in C-Reactive Protein (CRP): Ratio to Baseline","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"GEOMETRIC_MEAN","dispersionType":"Geometric Coefficient of Variation","unitOfMeasure":"Ratio of C-reactive protein","timeFrame":"From baseline (week -2) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"241"},{"groupId":"OG001","value":"243"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.55","spread":"121.5"},{"groupId":"OG001","value":"0.92","spread":"105.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"242"}]}],"classes":[{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"34.1"},{"groupId":"OG001","value":"90.5"}]}]},{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"65.9"},{"groupId":"OG001","value":"9.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving 15% Weight Loss (Yes/No)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"242"}]}],"classes":[{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"56.1"},{"groupId":"OG001","value":"97.9"}]}]},{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"43.9"},{"groupId":"OG001","value":"2.1"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving 20% Weight Loss (Yes/No)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"242"}]}],"classes":[{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"76.4"},{"groupId":"OG001","value":"99.6"}]}]},{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"23.6"},{"groupId":"OG001","value":"0.4"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"243"},{"groupId":"OG001","value":"237"}]}],"classes":[{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"24.7"},{"groupId":"OG001","value":"36.3"}]}]},{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"75.3"},{"groupId":"OG001","value":"63.7"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of participants","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"243"},{"groupId":"OG001","value":"237"}]}],"classes":[{"title":"No","categories":[{"measurements":[{"groupId":"OG000","value":"36.6"},{"groupId":"OG001","value":"51.5"}]}]},{"title":"Yes","categories":[{"measurements":[{"groupId":"OG000","value":"63.4"},{"groupId":"OG001","value":"48.5"}]}]}]},{"type":"SECONDARY","title":"Change in KCCQ Overall Summary Score (KCCQ-OSS)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Score on a scale","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"243"},{"groupId":"OG001","value":"237"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"16.8","spread":"18.3"},{"groupId":"OG001","value":"10.9","spread":"17.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"243"},{"groupId":"OG001","value":"237"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"43.2"},{"groupId":"OG001","value":"32.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in 6MWD (PGI-S)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"Percentage of Participants","timeFrame":"From baseline (week 0) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"240"},{"groupId":"OG001","value":"225"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"42.5"},{"groupId":"OG001","value":"28.0"}]}]}]},{"type":"SECONDARY","title":"Change in Systolic Blood Pressure (SBP)","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"millimetre of mercury (mmHg)","timeFrame":"From baseline (week -2) to end of treatment (week 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. The treatment period was 52 weeks."},{"id":"OG001","title":"Placebo","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received placebo once weekly by subcutaneous injection (in the abdomen, thigh or upper arm) for 52 weeks. The dose escalation and maintenance of placebo matched that of semaglutide."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"246"},{"groupId":"OG001","value":"243"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-6.4","spread":"19.0"},{"groupId":"OG001","value":"-1.1","spread":"17.5"}]}]}]},{"type":"SECONDARY","title":"Change in Waist Circumference","description":"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.","populationDescription":"FAS included all the randomized participants for this trial. Here, Overall Number of Participants Analyzed\" signifies those participants who had an observed value at week 52.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"Centimeter","timeFrame":"From baseline (week 0) to end of treatment (visit 52)","groups":[{"id":"OG000","title":"Semaglutide 2.4 mg","description":"Participants with obesity (BMI ≥30.0 kg/m\\^2) related heart failure with preserved ejection fraction received semaglutide 2.4 mg once weekly by subcutaneous injection (in the abdomen, thigh or upper arm). Participants initially received 0.25 mg of semaglutide. The dose was then escalated every fourth week with increments of 0.25 mg for 16 weeks until the target dose of 2.4 mg was reached. 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