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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1243-4358 | Other Identifier | World Health Organization (WHO) | |
| 2019-004452-11 | Registry Identifier | European Medicines Agency (EudraCT) |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semaglutide | Experimental | 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 (semaglutide) | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaglutide | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) | 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. | From baseline (week 0) to end of treatment (week 52) |
| Change in Body Weight | 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. | From baseline (week 0) to end of treatment (week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Six-minute Walking Distance (6MWD) | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eastern Shore Rsrch Inst, LLC | Fairhope | Alabama | 36532 | United States | ||
| National Heart Institute Cal |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37635157 | Background | 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. | |
| 37622681 |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | Semaglutide 2.4 mg | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2023 | Jun 8, 2024 |
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Sponsor staff involved in the clinical trial is masked according to company standard procedures.
|
| Placebo (semaglutide) | Drug | 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. |
|
| From baseline (week 0) to end of treatment (week 52) |
| The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs | 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. | From baseline (week 0) to end of study (week 57) |
| Change in C-Reactive Protein (CRP): Ratio to Baseline | 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. | From baseline (week -2) to end of treatment (week 52) |
| Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No) | 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. | From baseline (week 0) to end of treatment (week 52) |
| Percentage of Participants Achieving 15% Weight Loss (Yes/No) | 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. | From baseline (week 0) to end of treatment (week 52) |
| Percentage of Participants Achieving 20% Weight Loss (Yes/No) | 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. | From baseline (week 0) to end of treatment (week 52) |
| Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No) | 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. | From baseline (week 0) to end of treatment (week 52) |
| Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No) | 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. | From baseline (week 0) to end of treatment (week 52) |
| Change in KCCQ Overall Summary Score (KCCQ-OSS) | 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. | From baseline (week 0) to end of treatment (week 52) |
| Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S) | 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. | From baseline (week 0) to end of treatment (week 52) |
| Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in 6MWD (PGI-S) | 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. | From baseline (week 0) to end of treatment (week 52) |
| Change in Systolic Blood Pressure (SBP) | 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. | From baseline (week -2) to end of treatment (week 52) |
| Change in Waist Circumference | 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. | From baseline (week 0) to end of treatment (visit 52) |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Keck Medical Center of USC - Outpatient Clinic | Los Angeles | California | 90033 | United States |
| Lundquist Inst-Biomed Innovtn | Torrance | California | 90502 | United States |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | United States |
| First Coast Cardiovascular Institute | Jacksonville | Florida | 32257 | United States |
| Baptist Heart Specialists_Jacksonville | Jacksonville | Florida | 32258 | United States |
| CV Res Ctr of S Florida | Miami | Florida | 33173 | United States |
| Endeavor Health Clinical Operations-NCH | Arlington Heights | Illinois | 60005 | United States |
| University of Chicago Medicine | Chicago | Illinois | 60637 | United States |
| Endeavor Health Glenbook Hosp | Evanston | Illinois | 60201 | United States |
| Northwestern University_Chicago_0 | Evanston | Illinois | 60208 | United States |
| Chicago Medical Research LLC | Hazel Crest | Illinois | 60429 | United States |
| Ascension St. Vincent Medical Group | Indianapolis | Indiana | 46260 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| University of Kansas Medical Center_Kansas City | Kansas City | Kansas | 66160 | United States |
| Cotton-O'Neil Heart Center | Topeka | Kansas | 66606 | United States |
| The Research Group of Lexington LLC | Lexington | Kentucky | 40503 | United States |
| Baptist Health Louisville | Louisville | Kentucky | 40207 | United States |
| Baptist Health Madisonville, Inc | Madisonville | Kentucky | 42431 | United States |
| Grace Research, LLC | Bossier City | Louisiana | 71111 | United States |
| Heart Clinic of Hammond | Hammond | Louisiana | 70403 | United States |
| Grace Research, LLC_Shreveport | Shreveport | Louisiana | 71105 | United States |
| Louisiana Heart Center_Slidell | Slidell | Louisiana | 70458 | United States |
| Louisiana Heart Center | Slidell | Louisiana | 70458 | United States |
| Ascension Saint Agnes Heart Ca | Baltimore | Maryland | 21229 | United States |
| John Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202-2689 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | United States |
| Univ of Mississippi Med Ctr | Jackson | Mississippi | 39216 | United States |
| Saint Luke's Hospital of Kansas City | Kansas City | Missouri | 64111 | United States |
| St Louis Heart & Vascular, P.C. | St Louis | Missouri | 63136 | United States |
| Bryan Heart | Lincoln | Nebraska | 68506 | United States |
| CHI Health Clinic Cardiology (CUMC - Bergan Mercy) | Omaha | Nebraska | 68124 | United States |
| St Francis Hospital Lindner Research Center | Greenvale | New York | 11548 | United States |
| NY Presbyt Hosp-W Cornell Med | New York | New York | 10021 | United States |
| Rochester General Hospital | Rochester | New York | 14621 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Lindner Center,Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| Abington Memorial Hospital | Abington | Pennsylvania | 19001 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Hospital of University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Medical Univ of South Carolina_Charleston_0 | Charleston | South Carolina | 29425 | United States |
| Sanford Health_Sioux Falls | Sioux Falls | South Dakota | 57117 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | United States |
| Cardiology Consultants of Danville Inc. | Danville | Virginia | 24541 | United States |
| Virginia Heart | Falls Church | Virginia | 22042 | United States |
| Sentara Health Research Center | Norfolk | Virginia | 23507 | United States |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23298-5058 | United States |
| CEMEDIC | CABA | Buenos Aires | C1440CFD | Argentina |
| Master Centre for Argentina | San Carlos de Bolivar | Buenos Aires | 1334 | Argentina |
| Centro de Investigación y Prevención Cardiovascular | CABA | C1061AAS. | Argentina |
| Centro de Investigación y Prevención Cardiovascular | CABA | C1119ACN | Argentina |
| CEMEDIC | CABA | C1440CFD | Argentina |
| Cardiología Palermo Duplicate | Ciudad Autónoma de Buenos Aire | 1425 | Argentina |
| Cardiología Palermo | Ciudad Autónoma de Buenos Aire | 1425 | Argentina |
| Instituto de Cardiología de Corrientes | Corrientes | W3400AMZ | Argentina |
| Consultorio Integral de Atención al Diabético | Morón | B1708IFF | Argentina |
| Sanatorio Britanico S.A. | Rosario, Santa Fe | S2000CVB | Argentina |
| The Canberra Hospital_Garran | Garran | Australian Capital Territory | 2605 | Australia |
| Concord Repatriation General Hospital - Cardiology Department | Concord | New South Wales | 2139 | Australia |
| Liverpool Hospital | Liverpool | New South Wales | 2170 | Australia |
| Royal Brisbane Hospital | Herston | Queensland | 4029 | Australia |
| Flinders Medical Centre | Bedford Park | South Australia | 5042 | Australia |
| Geelong Cardiology Research Unit | Geelong | Victoria | 3220 | Australia |
| University of Calgary_Calgary | Calgary | Alberta | T2N 4Z6 | Canada |
| Univ of Alberta Hosp Edmonton | Edmonton | Alberta | T6G 2B7 | Canada |
| North Shore Heart Centre | North Vancouver | British Columbia | V7M 2H4 | Canada |
| SMH Cardiology Clinical Trials Inc. | Surrey | British Columbia | V3V 0C6 | Canada |
| St. Boniface Hospital | Winnipeg | Manitoba | R2H 2HA6 | Canada |
| Cambridge Cardiac Care Centre | Cambridge | Ontario | N1R 6V6 | Canada |
| Partnrs Adv Cardio Eval (PACE) | Newmarket | Ontario | L3Y 2P6 | Canada |
| North York Diagn & Cardiac Ctr | North York | Ontario | M6B 3H7 | Canada |
| Oakville Cardiovascular Research LP | Oakville | Ontario | L6K 3W7 | Canada |
| Dr James Cha | Oshawa | Ontario | L1J 2K1 | Canada |
| Heart Health Institute Research, Inc. | Scarborough Village | Ontario | M1B 4Z8 | Canada |
| Dr. Louis Yao | Weston | Ontario | M9N 1W4 | Canada |
| Clinique Sante Cardio MC | Montreal | Quebec | H1T 3Y7 | Canada |
| Unv de Cardiologie et dePneum | Québec | G1V 4G5 | Canada |
| Nemocnice Jihlava Kardiologie | Jihlava | 586 33 | Czechia |
| Nemocnice Jihlava | Jihlava | 586 33 | Czechia |
| Vseobecna fakultni nemocnice a 1 LF UK v Praze | Prague | 128 00 | Czechia |
| Všeobecná fakultní nemocnice v Praze | Prague | 128 00 | Czechia |
| IKEM | Prague | 140 21 | Czechia |
| MEDICON a.s. | Prague | 170 00 | Czechia |
| Poliklinika Holešovice VISIONARY - Medicon Pharm s.r.o. | Prague | 170 00 | Czechia |
| Nemocnice Slany Kardiologie | Slaný | 274 01 | Czechia |
| Nemocnice Tábor a.s. | Tábor | 390 03 | Czechia |
| Herlev og Gentofte Hospital | Hellerup | Capital Region | 2900 | Denmark |
| Aarhus Universitetshospital, Hjertesygdomme | Aarhus N | 8200 | Denmark |
| Kardiologisk Odense & Svendborg | Svendborg | 5700 | Denmark |
| Charité - Campus Virchow-Klinikum - Kardiologie, Angiologie und Intensivmedizin (CRU) | Berlin | 13353 | Germany |
| Cardiologicum Dresden und Pirna - MVZ "Am Felsenkeller" (Dresden) | Dresden | 01277 | Germany |
| Zentrum fuer klinische Studien Suedbrandenburg GmbH | Elsterwerda | 04910 | Germany |
| MVZ CCB Frankfurt und Main-Taunus GbR | Frankfurt | 60389 | Germany |
| Medical Center - University Of Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Universitätsklinikum Freiburg - Medical Center | Freiburg im Breisgau | 79106 | Germany |
| Appel | Kassel | 34121 | Germany |
| B. Braun Ambulantes Herzzentrum Kassel MVZ GmbH | Kassel | 34121 | Germany |
| Universitatsklinikum Würzburg - Zentrum für Herzinsuffizienz | Würzburg | 97078 | Germany |
| Lausmed Kft. | Baja | Bács-Kiskun county | 6500 | Hungary |
| Selye János Kórház | Komárom | Komárom-Esztergom | 2921 | Hungary |
| Szent Margit Rendelőintézet Nonprofit Kft. | Budapest | 1032 | Hungary |
| Semmelweis Egyetem Szent Rókus Klinikai Tömb | Budapest | 1085 | Hungary |
| Gottsegen György Országos Kardiológiai Intézet | Budapest | 1096 | Hungary |
| Semmelweis Egyetem Városmajori Szív- és Érgyógyászat | Budapest | 1122 | Hungary |
| Jahn Ferenc Dél-pesti Kórház és Rendelőintézet | Budapest | 1204 | Hungary |
| Borsod-Abaúj-Zemplén Megyei Központi Kórház | Miskolc | 3526 | Hungary |
| Zala Megyei Szent Rafael Kórház | Zalaegerszeg | 8900 | Hungary |
| Hadassah Ein Karam MC - Cardio Department | Jerusalem | 91120 | Israel |
| Western Galilee MC - Cardiology Department | Nahariya | 22100 | Israel |
| Rabin MC Beilinson - Heart Failure Unit | Petah Tikva | 49100 | Israel |
| Sourasky MC - Cardio Vascular Research Center | Tel Aviv | 6423906 | Israel |
| Sheba MC - Cardiology Clinical Research Unit | Tel Litwinsky | 5265601 | Israel |
| Gelre Ziekenhuizen Apeldoorn | Apeldoorn | 7334 DZ | Netherlands |
| Rode Kruis Ziekenhuis Beverwijk | Beverwijk | 1942 LE | Netherlands |
| UMC Groningen | Groningen | 9713 GZ | Netherlands |
| Saxenburgh Medisch Centrum | Hardenberg | 7772 SE | Netherlands |
| Frisius MC Leeuwarden | Leeuwarden | 8934 AD | Netherlands |
| Bravis Ziekenhuis | Roosendaal | 4708 AE | Netherlands |
| Malopolskie Centrum Sercowo-Naczyniowe | Chrzanów | Lesser Poland Voivodeship | 32-500 | Poland |
| Uniwersytecki Szpital Kliniczny w Bialymstoku K. Kardio | Bialystok | Podlaskie Voivodeship | 15-540 | Poland |
| Ind. Prak. Lek. w dziedz. Kardiologii lek. med. K. Cymerman | Gdynia | Pomeranian Voivodeship | 81-157 | Poland |
| Pro Familia Altera Sp. z o.o. | Katowice | Silesian Voivodeship | 40-648 | Poland |
| I Katedra i Klinika Kardiologii WUM SPCSK | Warsaw | 02-097 | Poland |
| Uniwersytecki Szpital Kliniczny nr 2 Uniwersytetu Medycznego w Łodzi | Lodz | Łódź Voivodeship | 90-549 | Poland |
| Hospital Universitario La Zarzuela | Madrid | 28023 | Spain |
| Complejo Hospitalario Universitario de Santiago | Santiago de Compostela | 15706 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Yeovil District Hospital - Clinical Research Unit | Yeovil | Somerset | BA21 4AT | United Kingdom |
| St. Richards Hospital_Cardiology | Chichester | West Sussex | PO19 6SE | United Kingdom |
| Barnet Hospital - Cardiology Department | Barnet | EN5 3DJ | United Kingdom |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Glasgow Clinical Research Facility | Glasgow | G31 2ER | United Kingdom |
| Glasgow Royal Infirmary | Glasgow | G31 2ER | United Kingdom |
| Queen Elizabeth University Hospital | Glasgow | G51 4TF | United Kingdom |
| Wycombe General Hospital | High Wycombe | HP11 2TT | United Kingdom |
| Aintree University Hospital | Liverpool | L9 7AL | United Kingdom |
| University Hospital Aintree | Liverpool | L9 7AL | United Kingdom |
| Manchester Royal Infirmary | Manchester | M13 9WL | United Kingdom |
| Wythenshawe Hospital_North West Heart Centre | Manchester | M23 9LT | United Kingdom |
| Great Western Hospital | Swindon | SN3 6BB | United Kingdom |
| Musgrove Park Hospital | Taunton | TA1 5DA | United Kingdom |
| St George's Hospital | Tooting | SW17 0QT | United Kingdom |
| Result |
| 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. |
| 39222642 | Derived | 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. |
| 38739118 | Derived | 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. |
| 38599221 | Derived | 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. |
| 37993201 | Derived | 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. |
| 37952180 | Derived | 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. |
| FG001 | Placebo | 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. |
| Full Analysis Set (FAS) |
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| Safety Analysis Set (SAS) |
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| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS) population included all the randomized participants for this trial.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Semaglutide 2.4 mg | 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. |
| BG001 | Placebo | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | From baseline (week 0) to end of treatment (week 52) |
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| Primary | Change in Body Weight | 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. | 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. | Posted | Mean | Standard Deviation | Percentage of body weight | From baseline (week 0) to end of treatment (week 52) |
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| Secondary | Change in Six-minute Walking Distance (6MWD) | 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. | 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. | Posted | Mean | Standard Deviation | Meters | From baseline (week 0) to end of treatment (week 52) |
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| Secondary | The Hierarchical Composite Endpoint: Percentage of Wins of Participant Pairs | 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. | FAS included all the randomized participants for this trial. | Posted | Number | Percentages of wins of participant pairs | From baseline (week 0) to end of study (week 57) |
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| Secondary | Change in C-Reactive Protein (CRP): Ratio to Baseline | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio of C-reactive protein | From baseline (week -2) to end of treatment (week 52) |
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| Secondary | Percentage of Participants Achieving 10 Percent (%) Weight Loss (Yes/No) | 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. | 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. | Posted | Number | Percentage of participants | From baseline (week 0) to end of treatment (week 52) |
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| Secondary | Percentage of Participants Achieving 15% Weight Loss (Yes/No) | 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. | 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. | Posted | Number | Percentage of participants | From baseline (week 0) to end of treatment (week 52) |
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| Secondary | Percentage of Participants Achieving 20% Weight Loss (Yes/No) | 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. | 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. | Posted | Number | Percentage of participants | From baseline (week 0) to end of treatment (week 52) |
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| Secondary | Percentage of Participants Improving 5 Points or More in KCCQ Clinical Summary Score (Yes/No) | 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. | 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. | Posted | Number | Percentage of participants | From baseline (week 0) to end of treatment (week 52) |
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| Secondary | Percentage of Participants Improving 10 Points or More in KCCQ Clinical Summary Score (Yes/No) | 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. | 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. | Posted | Number | Percentage of participants | From baseline (week 0) to end of treatment (week 52) |
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| Secondary | Change in KCCQ Overall Summary Score (KCCQ-OSS) | 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. | 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. | Posted | Mean | Standard Deviation | Score on a scale | From baseline (week 0) to end of treatment (week 52) |
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| Secondary | Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in KCCQ-CSS (PGI-S) | 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. | 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. | Posted | Number | Percentage of Participants | From baseline (week 0) to end of treatment (week 52) |
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| Secondary | Percentage of Participants Achieving Threshold for Clinically Meaningful Within-participants Change in 6MWD (PGI-S) | 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. | 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. | Posted | Number | Percentage of Participants | From baseline (week 0) to end of treatment (week 52) |
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| Secondary | Change in Systolic Blood Pressure (SBP) | 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. | 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. | Posted | Mean | Standard Deviation | millimetre of mercury (mmHg) | From baseline (week -2) to end of treatment (week 52) |
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| Secondary | Change in Waist Circumference | 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. | 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. | Posted | Mean | Standard Deviation | Centimeter | From baseline (week 0) to end of treatment (visit 52) |
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From baseline (week 0) to end of trial (week 57)
All presented adverse events are treatment-emergent adverse events (TEAEs). A TEAEs was defined as an event that had onset during the on-treatment period (date of first trial product administration to date of last trial product administration excluding potential off-treatment time intervals triggered by at least five consecutive missed doses). SAS included all the participants who randomly assigned to trial treatment and who took at least one dose of trial product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
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| EG000 | Semaglutide 2.4 mg | 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. | 3 | 263 | 35 | 263 | 93 | 263 |
| EG001 | Placebo | 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. | 4 | 266 | 71 | 266 | 57 | 266 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Abdominal wall haematoma | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
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| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Amyloidosis | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Aortic valve stenosis | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Arterial injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Cardiac failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Cardiac failure acute | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Carotid artery stenosis | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Cerebral infarction | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 25.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 25.1 | Systematic Assessment |
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| Chondrocalcinosis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Chronic kidney disease | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
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| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Dysarthria | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Ejection fraction decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
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| Embolic stroke | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Endometrial cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| Endometritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Erysipelas | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
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| Haematoma evacuation | Surgical and medical procedures | MedDRA 25.1 | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Head injury | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
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| Hydrocele | Congenital, familial and genetic disorders | MedDRA 25.1 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypoglycaemic unconsciousness | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Medical observation | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Normochromic normocytic anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Osteolysis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiration abnormal | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory acidosis | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Spondylitis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Superficial spreading melanoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Tricuspid valve incompetence | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Uterine polyp | Reproductive system and breast disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2022 | Feb 6, 2025 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000591245 | semaglutide |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
| OG001 | Placebo | 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. |
|
|
|
|
|
|
|
|
|
|
| OG001 | Placebo | 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. |
|
|
| OG001 | Placebo | 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. |
|
|
| OG001 |
| Placebo |
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. |
|
|
| OG001 | Placebo | 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. |
|
|
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.
|
|
|
|
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. |
|
|