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A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

27. august 2026 opdateret af: Novo Nordisk A/S

A Clinical Study to Compare Efficacy and Safety of Two Different Doses of CagriSema and Semaglutide in Participants With Obesity With or Without Type 2 Diabetes

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

2500

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

      • Buenos Aires, Argentina, C1425AGC
        • Rekruttering
        • Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
      • Buenos Aires, Argentina, C1119ACU
        • Rekruttering
        • Kynet Recoleta
      • Buenos Aires, Argentina, C1015
        • Rekruttering
        • OMI- Organización Médica de Investigación
      • Buenos Aires, Argentina, C1419
        • Rekruttering
        • Hospital Sirio Libanês
      • CABA, Argentina, C1060ABA
        • Ikke rekrutterer endnu
        • CEDIC Centro de Investigación Clínica
      • CABA, Argentina, C1061AAS.
        • Rekruttering
        • CIPREC Arenales
      • CABA, Argentina, C1120AAC
        • Rekruttering
        • Centro Medico Viamonte SRL
      • Ciudad de Buenos Aires, Argentina, C1204AAD
        • Rekruttering
        • Instituto Centenario
      • Santa Fe, Argentina, S3000FSO
        • Rekruttering
        • CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
      • Santiago del Estero, Argentina, G4200
        • Rekruttering
        • Sanatorio Norte
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1440CFD
        • Rekruttering
        • CEMEDIC
      • Capital Federal, Buenos Aires, Argentina, C1056ABI
        • Rekruttering
        • Centro de Investigaciones Metabólicas
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1424CIQ
        • Rekruttering
        • CICEMO- Consultorio (Av Directorio)
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1427
        • Rekruttering
        • Centro Medico Arsema
    • Tucumán Province
      • San Miguel de Tucumán, Tucumán Province, Argentina, T4000DPX
        • Rekruttering
        • Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio
    • New South Wales
      • Campbelltown, New South Wales, Australien, 2560
        • Rekruttering
        • Sydney Clinical Trials
      • Gosford, New South Wales, Australien, 2250
        • Rekruttering
        • Gosford Renal Research
      • Liverpool, New South Wales, Australien, 2170
        • Rekruttering
        • Sydney Cardiometabolic Centre
      • Merewether, New South Wales, Australien, 2291
        • Rekruttering
        • Hunter Diabetes Centre
    • Queensland
      • Birtinya, Queensland, Australien, 4575
        • Rekruttering
        • University of Sunshine Coast - Vitality Village
      • South Brisbane, Queensland, Australien, 4101
        • Rekruttering
        • University of Sunshine Coast - South Brisbane
    • Victoria
      • Camberwell, Victoria, Australien, 3124
        • Rekruttering
        • Emeritus Research Melbourne
      • Alken, Belgien, 3570
        • Rekruttering
        • Anima Research Center
      • Brussels, Belgien, 1200
        • Ikke rekrutterer endnu
        • Cliniques universitaires Saint-Luc
      • Kluisbergen, Belgien, 9690
        • Rekruttering
        • KORMONT
      • La Louvière, Belgien, 7100
        • Rekruttering
        • CHU Tivoli
      • Mechelen, Belgien, 2800
        • Rekruttering
        • Meclinas
      • Roeselare, Belgien, 8800
        • Rekruttering
        • AZ Delta - Roeselare
      • Zwalm, Belgien, 9630
        • Rekruttering
        • KORMONT
      • Burgas, Bulgarien, 8000
        • Rekruttering
        • MC For Life EOOD
      • Kazanlak, Bulgarien, 6100
        • Rekruttering
        • MC Kazanlak EOOD
      • Kyustendil, Bulgarien, 2500
        • Rekruttering
        • Medical center Medi City 21 OOD
      • Pleven, Bulgarien, 5800
        • Rekruttering
        • OCSOMCE - Dr. Albena Dinkova EOOD
      • Plovdiv, Bulgarien, 4000
        • Rekruttering
        • AIPSMCEMDID - Dr. Georgi Levterov EOOD
      • Plovdiv, Bulgarien, 4002
        • Rekruttering
        • DCC Sveti Georgi EOOD
      • Sofia, Bulgarien, 1618
        • Rekruttering
        • MC Diamedical - 2013 OOD, Sofia
      • Sofia, Bulgarien, 1463
        • Rekruttering
        • Hipocrat 9 - Dr. Rumyana Boykova - Draganova - AISPEMD EOOD
      • Sofia, Bulgarien, 1618
        • Rekruttering
        • DCC XX - Sofia EOOD, Endocrinology
      • Sofia, Bulgarien, 1618
        • Rekruttering
        • Medical Centre Medical Arts Medico-dental centre
      • Sofia, Bulgarien, 1712
        • Rekruttering
        • DCC XXV Sofia EOOD, Endocrinology Consulting room
      • Stara Zagora, Bulgarien, 6003
        • Rekruttering
        • UMHAT Prof. Dr. Stoyan Kirkovich AD
      • Varna, Bulgarien, 9010
        • Rekruttering
        • AIPSMC Dr. Evelina Zlatanova EOOD
      • Veliko Tarnovo, Bulgarien, 5005
        • Rekruttering
        • MC Nevromedics EOOD, Internal Diseases
      • Québec, Canada, G2J 0C4
        • Rekruttering
        • Alpha Recherche Clinique - Lebourgneuf
      • Québec, Canada, G1V 4T3
        • Rekruttering
        • Diex Recherche Québec
    • Alberta
      • Calgary, Alberta, Canada, T2V 4J2
        • Rekruttering
        • C-Health Partners
    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 5A8
        • Rekruttering
        • Kelowna Health and Memory Centre Ltd.
      • Kelowna, British Columbia, Canada, V1Y4N7
        • Rekruttering
        • Medical Arts Health Research Group_Kelowna
      • Surrey, British Columbia, Canada, V3Z 2N6
        • Rekruttering
        • Ocean West Research Clinic
      • Surrey, British Columbia, Canada, V4A 0C1
        • Rekruttering
        • Hilltop Medical Clinic
      • Victoria, British Columbia, Canada, V8V 4A1
        • Rekruttering
        • Dr. M.B. Jones Inc
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1G 1A7
        • Rekruttering
        • G.A. Research Associates Ltd.
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H1V7
        • Rekruttering
        • Nova Scotia Hlth Halifax
      • Sydney, Nova Scotia, Canada, B1M 0A1
        • Rekruttering
        • Care Access Cape Breton
    • Ontario
      • Brampton, Ontario, Canada, L6S 0C6
        • Rekruttering
        • Centricity Research Brampton Endocrinology
      • Guelph, Ontario, Canada, N1G 0B4
        • Ikke rekrutterer endnu
        • Apex Trials
      • Hamilton, Ontario, Canada, L8L 5G4
        • Rekruttering
        • Premier Clinical Trial Research Network (PCTRN)
      • Hamilton, Ontario, Canada, L8L 5G4
        • Rekruttering
        • Hamilton Medical Research Group
      • Hamilton, Ontario, Canada, L8L 5G8
        • Rekruttering
        • Wharton Medical Clinic Clinical Trials (Hamilton)
      • London, Ontario, Canada, N5W 6A2
        • Rekruttering
        • Milestone Research
      • Sarnia, Ontario, Canada, N7T 4X3
        • Rekruttering
        • Bluewater Clin Res Group Inc
      • Toronto, Ontario, Canada, M6G 1M2
        • Rekruttering
        • Diabetes Heart Research Centre
    • Quebec
      • Montreal, Quebec, Canada, H4N 2W2
        • Rekruttering
        • Centre Medical Acadie
      • Pointe-Claire, Quebec, Canada, H9R 4S3
        • Rekruttering
        • Centricity Res Pointe-Claire
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • Aktiv, ikke rekrutterende
        • Uni of Alabama at Birmingham
      • Pelham, Alabama, Forenede Stater, 35124
        • Aktiv, ikke rekrutterende
        • Cahaba Research
    • Arizona
      • Gilbert, Arizona, Forenede Stater, 85296
        • Aktiv, ikke rekrutterende
        • Elligo Health Research Inc
      • Phoenix, Arizona, Forenede Stater, 85006
        • Aktiv, ikke rekrutterende
        • Velocity Clinical Research-Phoenix
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Aktiv, ikke rekrutterende
        • Arkansas Clinical Research
      • Little Rock, Arkansas, Forenede Stater, 72211
        • Aktiv, ikke rekrutterende
        • Woodland Int. Research Group
    • California
      • Escondido, California, Forenede Stater, 92025
        • Aktiv, ikke rekrutterende
        • Neighborhood Healthcare
      • Escondido, California, Forenede Stater, 92025
        • Aktiv, ikke rekrutterende
        • Headlands Research California, LLC
      • La Mesa, California, Forenede Stater, 91942
        • Aktiv, ikke rekrutterende
        • Diabetes & Endocrine Specialists - La Mesa
      • Lincoln, California, Forenede Stater, 95648
        • Aktiv, ikke rekrutterende
        • Clinical Trials Research_Sacramento
      • Loma Linda, California, Forenede Stater, 92354
        • Aktiv, ikke rekrutterende
        • Loma Linda University Faculty Medical Clinics
      • Los Alamitos, California, Forenede Stater, 90720
        • Aktiv, ikke rekrutterende
        • Pacific Clinical Studies
      • Northridge, California, Forenede Stater, 91325
        • Aktiv, ikke rekrutterende
        • Valley Clinical Trials
      • Palm Springs, California, Forenede Stater, 92262
        • Aktiv, ikke rekrutterende
        • Desert Oasis Healthcare
      • San Diego, California, Forenede Stater, 92111
        • Aktiv, ikke rekrutterende
        • Linda Vista Health Care Ctr
      • Van Nuys, California, Forenede Stater, 91405
        • Aktiv, ikke rekrutterende
        • Velocity Clin Res - Van Nuys
      • Walnut Creek, California, Forenede Stater, 94598
        • Aktiv, ikke rekrutterende
        • Flourish Research - CA
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Afsluttet
        • University Of Colorado Hospital
    • Florida
      • Clearwater, Florida, Forenede Stater, 33761
        • Aktiv, ikke rekrutterende
        • TBMR & Alcanza
      • Fleming Island, Florida, Forenede Stater, 32003
        • Aktiv, ikke rekrutterende
        • Northeast Research Institute
      • Jacksonville, Florida, Forenede Stater, 32204
        • Aktiv, ikke rekrutterende
        • Northeast Research Institute
      • Jacksonville, Florida, Forenede Stater, 32205
        • Aktiv, ikke rekrutterende
        • Westside Center for Clinical Research
      • Miami, Florida, Forenede Stater, 33165
        • Aktiv, ikke rekrutterende
        • New Horizon Research Center
      • Miami, Florida, Forenede Stater, 33155
        • Aktiv, ikke rekrutterende
        • BioClinical Research Alliance
      • Miramar, Florida, Forenede Stater, 33027
        • Aktiv, ikke rekrutterende
        • South Broward Research LLC
      • Ocoee, Florida, Forenede Stater, 34761
        • Aktiv, ikke rekrutterende
        • West Orange Endocrinology
      • Oviedo, Florida, Forenede Stater, 32765
        • Aktiv, ikke rekrutterende
        • Oviedo Medical Research, LLC
      • Pembroke Pines, Florida, Forenede Stater, 33024
        • Aktiv, ikke rekrutterende
        • Clinical Trial Services Corp
    • Georgia
      • Conyers, Georgia, Forenede Stater, 30094
        • Aktiv, ikke rekrutterende
        • Hope Clin Res & Wellness
      • Gainesville, Georgia, Forenede Stater, 30501
        • Aktiv, ikke rekrutterende
        • Center for Adv Res & Education
      • Roswell, Georgia, Forenede Stater, 30076
        • Aktiv, ikke rekrutterende
        • Endocrine Research Solutions, Inc
      • Woodstock, Georgia, Forenede Stater, 30189-4255
        • Aktiv, ikke rekrutterende
        • North Georgia Clinical Research
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83646
        • Aktiv, ikke rekrutterende
        • Solaris Clinical Research
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60607
        • Aktiv, ikke rekrutterende
        • Cedar-Crosse Research Center
      • Gillespie, Illinois, Forenede Stater, 62033
        • Aktiv, ikke rekrutterende
        • Macoupin Fam Practice Ctr, LLP
      • Gurnee, Illinois, Forenede Stater, 60031
        • Aktiv, ikke rekrutterende
        • Clinical Investigation Spec Gurnee
      • Skokie, Illinois, Forenede Stater, 60077
        • Aktiv, ikke rekrutterende
        • Evanston Premier Hlthcr Res
      • Skokie, Illinois, Forenede Stater, 60077
        • Aktiv, ikke rekrutterende
        • Endeavor Health
    • Iowa
      • West Des Moines, Iowa, Forenede Stater, 50266
        • Aktiv, ikke rekrutterende
        • Iowa Diabetes Research
    • Kansas
      • Newton, Kansas, Forenede Stater, 67114
        • Aktiv, ikke rekrutterende
        • Alliance for Multispecialty Research
      • Topeka, Kansas, Forenede Stater, 66606
        • Aktiv, ikke rekrutterende
        • Cotton O'Neil Diab & Endo Ctr
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40503
        • Aktiv, ikke rekrutterende
        • The Research Group of Lexington LLC
    • Maryland
      • Rockville, Maryland, Forenede Stater, 20852
        • Ikke rekrutterer endnu
        • Endo and Metabolic Consultants
    • Michigan
      • Buckley, Michigan, Forenede Stater, 49620
        • Aktiv, ikke rekrutterende
        • Northern Pines Hlth Ctr, PC
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55416
        • Ikke rekrutterer endnu
        • International Diabetes Center
      • Richfield, Minnesota, Forenede Stater, 55423
        • Aktiv, ikke rekrutterende
        • AES Minneapolis DRS
    • Mississippi
      • Belzoni, Mississippi, Forenede Stater, 39038
        • Aktiv, ikke rekrutterende
        • Belzoni Clinical Research
    • Missouri
      • Chesterfield, Missouri, Forenede Stater, 63005
        • Aktiv, ikke rekrutterende
        • Clinical Research Professionals
      • St Louis, Missouri, Forenede Stater, 63128
        • Aktiv, ikke rekrutterende
        • Amicis Centers of Clinical Research
    • New York
      • West Seneca, New York, Forenede Stater, 14224
        • Aktiv, ikke rekrutterende
        • Southgate Medical Group, LLP
    • North Carolina
      • Greensboro, North Carolina, Forenede Stater, 27408
        • Aktiv, ikke rekrutterende
        • PharmQuest Life Sciences LLC
      • Greenville, North Carolina, Forenede Stater, 27834
        • Aktiv, ikke rekrutterende
        • Physician's East Endocrinology
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Aktiv, ikke rekrutterende
        • Carteret Medical Group
      • Morehead City, North Carolina, Forenede Stater, 28557
        • Aktiv, ikke rekrutterende
        • Centricity Rsrch MHCity Multi
      • Statesville, North Carolina, Forenede Stater, 28625
        • Aktiv, ikke rekrutterende
        • Piedmont Healthcare/Research
      • Wilmington, North Carolina, Forenede Stater, 28401
        • Aktiv, ikke rekrutterende
        • Accellacare Wilmington
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58104
        • Aktiv, ikke rekrutterende
        • Lillestol Research LLC
      • Fargo, North Dakota, Forenede Stater, 58104
        • Ikke rekrutterer endnu
        • Plains Clinical Research Center, LLC
    • Ohio
      • Maumee, Ohio, Forenede Stater, 43537
        • Aktiv, ikke rekrutterende
        • Advanced Medical Research
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater, 73072
        • Aktiv, ikke rekrutterende
        • Lynn Institute of Norman
      • Norman, Oklahoma, Forenede Stater, 73069
        • Aktiv, ikke rekrutterende
        • Alliance for Multispecialty Research
    • Pennsylvania
      • Beaver, Pennsylvania, Forenede Stater, 15009
        • Ikke rekrutterer endnu
        • Heritage Valley Medical Group
      • Hatboro, Pennsylvania, Forenede Stater, 19040
        • Aktiv, ikke rekrutterende
        • Hatboro Med Associates
      • Philadelphia, Pennsylvania, Forenede Stater, 19114
        • Aktiv, ikke rekrutterende
        • Northeast Endocrine Metabolic Associates
    • Rhode Island
      • Cumberland, Rhode Island, Forenede Stater, 02864
        • Aktiv, ikke rekrutterende
        • Clinical Res Collaborative
    • South Carolina
      • Gaffney, South Carolina, Forenede Stater, 29340
        • Aktiv, ikke rekrutterende
        • Velocity Clinical Research-Gaffney
      • Spartanburg, South Carolina, Forenede Stater, 29303
        • Aktiv, ikke rekrutterende
        • Spartanburg Medical Research
    • Tennessee
      • Jackson, Tennessee, Forenede Stater, 38305
        • Aktiv, ikke rekrutterende
        • Jackson Clinic
      • Kingsport, Tennessee, Forenede Stater, 37660
        • Aktiv, ikke rekrutterende
        • Holston Medical Group
      • Memphis, Tennessee, Forenede Stater, 38119
        • Aktiv, ikke rekrutterende
        • CNS Healthcare
      • Morristown, Tennessee, Forenede Stater, 37813
        • Aktiv, ikke rekrutterende
        • HealthStar Physicians, PC
      • Nashville, Tennessee, Forenede Stater, 37203
        • Aktiv, ikke rekrutterende
        • Clinical Research Associates
    • Texas
      • Amarillo, Texas, Forenede Stater, 79124
        • Aktiv, ikke rekrutterende
        • Amarillo Med Spec LLP
      • Austin, Texas, Forenede Stater, 78731
        • Aktiv, ikke rekrutterende
        • Texas Diab & Endo, P.A.
      • Austin, Texas, Forenede Stater, 78759
        • Aktiv, ikke rekrutterende
        • Velocity Clinical Research Austin
      • Dallas, Texas, Forenede Stater, 75230
        • Aktiv, ikke rekrutterende
        • Velocity Clin Res, Dallas
      • Dallas, Texas, Forenede Stater, 75231
        • Aktiv, ikke rekrutterende
        • North Texas Endocrine Center
      • Euless, Texas, Forenede Stater, 76040
        • Aktiv, ikke rekrutterende
        • Cedar Health Research
      • Houston, Texas, Forenede Stater, 77079
        • Aktiv, ikke rekrutterende
        • The Endocrine Center
      • Houston, Texas, Forenede Stater, 77040
        • Aktiv, ikke rekrutterende
        • JCCT- Juno NW Houston
      • Katy, Texas, Forenede Stater, 77450
        • Aktiv, ikke rekrutterende
        • Medical Colleagues-Texas LLP
      • Kerrville, Texas, Forenede Stater, 78028
        • Aktiv, ikke rekrutterende
        • Sante Clinical Research
      • Lampasas, Texas, Forenede Stater, 76550
        • Aktiv, ikke rekrutterende
        • Radiance Clinical Research
      • Laredo, Texas, Forenede Stater, 78041
        • Aktiv, ikke rekrutterende
        • Aeres Clinical Research
      • Longview, Texas, Forenede Stater, 75605
        • Aktiv, ikke rekrutterende
        • DCOL Ctr for Clin Res
      • McAllen, Texas, Forenede Stater, 78503
        • Aktiv, ikke rekrutterende
        • RGV Endocrine Center
      • San Antonio, Texas, Forenede Stater, 78229
        • Aktiv, ikke rekrutterende
        • AES San Antonio
      • San Antonio, Texas, Forenede Stater, 78233
        • Aktiv, ikke rekrutterende
        • Northeast Clinical Research of San Antonio
      • San Antonio, Texas, Forenede Stater, 78209
        • Aktiv, ikke rekrutterende
        • Quality Research Inc
      • Shavano Park, Texas, Forenede Stater, 78231
        • Aktiv, ikke rekrutterende
        • Consano Clinical Research, LLC
      • Sugar Land, Texas, Forenede Stater, 77478
        • Aktiv, ikke rekrutterende
        • Mt Olympus Medical Research, LLC
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84109
        • Aktiv, ikke rekrutterende
        • J.Lewis Research Inc
      • Salt Lake City, Utah, Forenede Stater, 84121
        • Aktiv, ikke rekrutterende
        • J.Lewis Research Inc
      • Sandy City, Utah, Forenede Stater, 84093
        • Aktiv, ikke rekrutterende
        • Diabetes & Endo Tx Specialists
      • South Jordan, Utah, Forenede Stater, 84095
        • Aktiv, ikke rekrutterende
        • J.Lewis Research Inc
    • Virginia
      • Newport News, Virginia, Forenede Stater, 23606
        • Aktiv, ikke rekrutterende
        • Health Res of Hampton Roads
      • Newport News, Virginia, Forenede Stater, 23606
        • Aktiv, ikke rekrutterende
        • Tidewater Physicians Multispecialty Group
      • Richmond, Virginia, Forenede Stater, 23294
        • Aktiv, ikke rekrutterende
        • National Clin Res Inc.
    • Wisconsin
      • Green Bay, Wisconsin, Forenede Stater, 54303
        • Ikke rekrutterer endnu
        • Prevea Health
      • Bois-Guillaume, Frankrig, 76230
        • Ikke rekrutterer endnu
        • CHU ROUEN_HOPITAL DE BOIS GUILLAUME_Service de Nutrition
      • Colmar, Frankrig, 68024
        • Ikke rekrutterer endnu
        • CENTRE HOSPITALIER DE COLMAR_Endocrinologie/Diabetologie/Centre Nutritionnel
      • Le Coudray, Frankrig, 28630
        • Aktiv, ikke rekrutterende
        • LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service d'endocrinologie
      • Paris, Frankrig, 75015
        • Ikke rekrutterer endnu
        • HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie
      • Paris, Frankrig, 75013
        • Aktiv, ikke rekrutterende
        • APHP - LA PITIE SALPETRIERE _ Service de Nutrition
      • Pessac, Frankrig, 33600
        • Ikke rekrutterer endnu
        • CHU DE BORDEAUX-HOPITAL HAUT LEVEQUE_Service d'Endocrinologie, Diabétologie et Maladies Métaboliques
      • Pierre-Bénite, Frankrig, 69310
        • Ikke rekrutterer endnu
        • HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition
      • Saint-Herblain, Frankrig, 44800
        • Afsluttet
        • CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition
      • Vénissieux, Frankrig, 69200
        • Aktiv, ikke rekrutterende
        • CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques
      • Alexandroupoli, Grækenland, 68100
        • Ikke rekrutterer endnu
        • University General Hospital Of Alexandroupoli - First Department of Internal Medicine
      • Athens, Grækenland, 115 27
        • Rekruttering
        • Laiko General Hospital Of Athens - 1st department of Internal Medicine
      • Athens, Grækenland, 11528
        • Rekruttering
        • General Hospital Of Athens Alexandra - Clinical Therapeutics
      • Athens, Grækenland, 10676
        • Rekruttering
        • Evangelismos S.A. - Endocrinology department
      • Athens, Grækenland, 11525
        • Rekruttering
        • Athens Medical Center S.A. (Iatriko Psychikou) - Department of Internal Medicine & Metabolic Diseases
      • Lamia, Grækenland, 35100
        • Ikke rekrutterer endnu
        • General Hospital Of Lamia - Internal Medicine Clinic
      • Marousi, Grækenland, 15125
        • Rekruttering
        • Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit
      • Palaió Fáliro, Grækenland, 17562
        • Rekruttering
        • Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center
      • Peristeri, Grækenland, 121 31
        • Rekruttering
        • Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department
      • Thessaloniki, Grækenland, 54635
        • Rekruttering
        • NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
      • Thessaloniki, Grækenland, 57001
        • Rekruttering
        • Thermi Clinic S.A. - Diabetes and Internal Medicine Department
      • Thessaloniki, Grækenland, 546 39
        • Ikke rekrutterer endnu
        • Athens Medical Center S.A., European Interbalkan Medical Center - Department of Internal Medicine
      • Thessaloniki, Grækenland, 54635
        • Rekruttering
        • General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic
      • Arnhem, Holland, 6815 AD
        • Rekruttering
        • Rijnstate Ziekenhuis
      • Eindhoven, Holland, 5623 EJ
        • Ikke rekrutterer endnu
        • Catharina Zkh Eindhoven - Interne geneeskunde
      • Hoofddorp, Holland, 2134 TM
        • Ikke rekrutterer endnu
        • Spaarne Gasthuis Hoofddorp - Interne
      • Hoogeveen, Holland, 7909 AA
        • Rekruttering
        • Bethesda Diabetes Research Center
      • Rotterdam, Holland, 3083 AN
        • Rekruttering
        • Ikazia Ziekenhuis
      • The Hague, Holland, 2565 KV
        • Rekruttering
        • Medisch Centrum Thomsonplein
    • Limburg
      • Born, Limburg, Holland, 6121 XK
        • Rekruttering
        • PreCare Trial & Recruitment
    • North Brabant
      • 's-Hertogenbosch, North Brabant, Holland, 5223 LA
        • Rekruttering
        • Progress Clinical Research Den Bosch
      • Catanzaro, Italien, 88100
        • Rekruttering
        • Azienda Ospedaliero-Universitaria Renato Dulbecco
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italien, 40138
        • Ikke rekrutterer endnu
        • AOU IRCCS Policlinico di Sant'Orsola Malpighi - UOC Endocrinologia e Prevenzione e Cura del Diabete
    • Liguria
      • Genoa, Liguria, Italien, 16132
        • Ikke rekrutterer endnu
        • IRCCS Ospedale Policlinico San Martino - U.O.D. Dietetica e Nutrizione Clinica
    • Lombardy
      • Brescia, Lombardy, Italien, 25123
        • Ikke rekrutterer endnu
        • Spedali Civili Brescia - SSD Endocrinologia
      • Milan, Lombardy, Italien, 20132
        • Rekruttering
        • Ospedale San Raffaele S.r.l. - Unità di Cardio-metabolismo e Trials Clinici
    • Pg
      • Perugia, Pg, Italien, 06129
        • Ikke rekrutterer endnu
        • Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
    • Sicily
      • Messina, Sicily, Italien, 98124
        • Rekruttering
        • D.A.I. Oncologico - U.O.C. di Chirurgia Generale ad indirizzo Oncologico
    • The Marches
      • Ancorna, The Marches, Italien, 60127
        • Rekruttering
        • INRCA Ancona - UOC Clinica Medica e Geriatrica
    • Tuscany
      • Pisa, Tuscany, Italien, 56126
        • Ikke rekrutterer endnu
        • Azienda Ospedaliero Universitaria Pisana
      • Bialystok, Polen, 15-276
        • Rekruttering
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Bialystok, Polen, 15-281
        • Ikke rekrutterer endnu
        • Gabinet Leczenia Otylosci i Chorob Dietozaleznych
      • Bialystok, Polen, 15-481
        • Rekruttering
        • Kresmed Sp. z o. o.
      • Bialystok, Polen, 15-797
        • Rekruttering
        • Renew Clinic Sp. z o.o.
      • Bygdoszcz, Polen, 85-796
        • Rekruttering
        • Gierach-Med
      • Dębica, Polen, 39-200
        • Rekruttering
        • ETG Lublin Sp. z o.o.
      • Katowice, Polen, 40-648
        • Rekruttering
        • Pro Familia Altera Sp. z o.o.
      • Katowice, Polen, 40-748
        • Rekruttering
        • Vita Longa Sp. z o. o.
      • Krakow, Polen, 30-149
        • Rekruttering
        • Małopolskie Centrum Kliniczne
      • Poznan, Polen, 61-251
        • Rekruttering
        • Maciej Wiza Gaja Poradnie Lekarskie
      • Rzeszów, Polen, 35-055
        • Rekruttering
        • Centrum Medyczne Medyk Sp.zo.o. Sp.k.
      • Warsaw, Polen, 02-679
        • Rekruttering
        • Medon Clinical Research Sp. z o.o.
      • Warsaw, Polen, 00-124
        • Rekruttering
        • Gyncentrum Sp. z o. o.
      • Wroclaw, Polen, 52-416
        • Ikke rekrutterer endnu
        • Centrum Medyczne Oporow
      • Wroclaw, Polen, 51-149
        • Ikke rekrutterer endnu
        • Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego
      • Almada, Portugal, 2805-267
        • Rekruttering
        • ULS Almada-Seixal E.P.E. - HGO_Serviço de Endocrinologia
      • Caldas da Rainha, Portugal, 2500-176
        • Rekruttering
        • ULS Do Oeste E.P.E. - Unidade Caldas da Rainha_CAMI - Unidade de Diabetes
      • Figueira da Foz Municipality, Portugal, 3094-001
        • Rekruttering
        • ULS Do Baixo Mondego, E.P.E. - HDFF_Serviço Cardiologia
      • Lisbon, Portugal, 1500-650
        • Rekruttering
        • Hospital da Luz Lisboa, S.A._Serviço de Medicina Interna
      • Senhora Da Hora, Matosinhos, Portugal, 4464-513
        • Rekruttering
        • ULS De Matosinhos, E.P.E - HPH_Serviço de Endocrinologia
      • Vila Nova de Gaia, Portugal, 4400-346
        • Rekruttering
        • Hospital da Luz Arrábida, S.A_Serviço de Endocrinologia
      • Vila do Conde, Portugal, 4480-565
        • Rekruttering
        • Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios Clínicos
    • Riachos
      • Torres Novas, Riachos, Portugal, 2350-325
        • Rekruttering
        • Ucardio Centro Clinico Unidade Cardiovascular
      • Brasov, Rumænien, 500101
        • Ikke rekrutterer endnu
        • Mariodiab Clinic SRL
      • Bucharest, Rumænien, 010507
        • Rekruttering
        • SC Nicodiab SRL
      • Buzău, Rumænien, 120133
        • Rekruttering
        • Mat Cord Biomedica S.R.L.
      • Oradea, Rumænien, 410469
        • Rekruttering
        • Spitalul Clinic Judetean De Urgenta Bihor
      • Piteşti, Rumænien, 110424
        • Rekruttering
        • Sc Sal Med Srl
      • Timișoara, Rumænien, 300723
        • Rekruttering
        • Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
      • Timișoara, Rumænien, 300288
        • Rekruttering
        • Cabinet Medical Dr Geru SRL
    • Bihor County
      • Oradea, Bihor County, Rumænien, 410159
        • Rekruttering
        • Grandmed SRL
    • Dolj
      • Craiova, Dolj, Rumænien, 200515
        • Rekruttering
        • S.C. Top Diabet Srl
    • Maramureş
      • Baia Mare, Maramureş, Rumænien, 430222
        • Rekruttering
        • CMI Dr Pop Lavinia
    • Mureș County
      • Târgu Mureş, Mureș County, Rumænien, 540142
        • Rekruttering
        • Sc Mediab Srl
      • Bojnice, Slovakiet, 97201
        • Aktiv, ikke rekrutterende
        • DIA - CLARUS s.r.o.
      • Bratislava, Slovakiet, 851 01
        • Aktiv, ikke rekrutterende
        • MEDISPEKTRUM s.r.o.
      • Bratislava, Slovakiet, 84108
        • Aktiv, ikke rekrutterende
        • KARDIO-SANUS, spol. s r.o.
      • Bytča, Slovakiet, 014 01
        • Aktiv, ikke rekrutterende
        • Diab - Int, s.r.o.
      • Košice, Slovakiet, 040 01
        • Aktiv, ikke rekrutterende
        • Human-Care, s.r.o.
      • Košice, Slovakiet, 04013
        • Aktiv, ikke rekrutterende
        • Endomed, s.r.o.
      • Martin, Slovakiet, 036 01
        • Aktiv, ikke rekrutterende
        • DIAMARTIN, s. r. o.
      • Spišská Nová Ves, Slovakiet, 05201
        • Aktiv, ikke rekrutterende
        • LUDIA, s. r. o.
      • A Coruña, Spanien, 15006
        • Rekruttering
        • Complejo Hospitalario Universitario A Coruña
      • Antequera, Spanien, 29200
        • Rekruttering
        • Hospital Comarcal de Antequera
      • Barcelona, Spanien, 08035
        • Ikke rekrutterer endnu
        • Hospital Vall d'hebrón
      • Barcelona, Spanien, 08028
        • Rekruttering
        • CAPSBE_CAP Ernest LLuch
      • Centelles (Barcelona), Spanien, 08540
        • Rekruttering
        • Eap Osona Sud Alt Congost S.L.P
      • Girona, Spanien, 17002
        • Rekruttering
        • Clínica Bofill
      • Madrid, Spanien, 28006
        • Rekruttering
        • Hospital Universitario de La Princesa
      • Madrid, Spanien, 28016
        • Ikke rekrutterer endnu
        • Hospital Universitario Sanitas Virgen del Mar
      • Madrid, Spanien, 28942
        • Ikke rekrutterer endnu
        • Hospital Universitario de Fuenlabrada
      • Madrid, Spanien, 28006
        • Afsluttet
        • Hosp. Univ. Ruber Juan Bravo_Endocrinología
      • Manresa, Spanien, 08243
        • Rekruttering
        • Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
      • Málaga, Spanien, 29010
        • Ikke rekrutterer endnu
        • H. Clinico Univ. Virgen de la Victoria
      • Valladolid, Spanien, 47004
        • Rekruttering
        • Hosp. Recoletas Salud Campo Grande_Endoc y Nutric
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, Sydafrika, 6001
        • Rekruttering
        • Phoenix Pharma
    • Free State
      • Bloemfontein, Free State, Sydafrika, 9301
        • Rekruttering
        • Iatros International
      • Bloemfontein, Free State, Sydafrika, 9301
        • Rekruttering
        • Medi-Clinic Bloemfontein
    • Gauteng
      • Johannesburg, Gauteng, Sydafrika, 1818
        • Rekruttering
        • Soweto Clinical Trial Centre
      • Johannesburg, Gauteng, Sydafrika, 1827
        • Rekruttering
        • Hemant Makan
      • Johannesburg, Gauteng, Sydafrika, 2001
        • Rekruttering
        • Newtown Clinical Research
      • Johannesburg, Gauteng, Sydafrika, 2196
        • Rekruttering
        • Sandton Medical Research
      • Johannesburg, Gauteng, Sydafrika, 2013
        • Rekruttering
        • Wits Bara Clinical Trial Site
      • Lenasia, Gauteng, Sydafrika, 1827
        • Aktiv, ikke rekrutterende
        • Lenasia Clinical Trial Centre
      • Pretoria, Gauteng, Sydafrika, 0186
        • Rekruttering
        • Clinical Trial Systems (CTC)
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, Sydafrika, 4450
        • Rekruttering
        • Dr Pillay's Rooms
    • Western Cape
      • Cape Town, Western Cape, Sydafrika, 7500
        • Rekruttering
        • Tread Research (Pty)Ltd
      • Mossel Bay, Western Cape, Sydafrika, 6500
        • Rekruttering
        • Dr Hendrik Snyman's Practice
      • Paarl, Cape Town, Western Cape, Sydafrika, 7646
        • Rekruttering
        • Paarl Research Centre
      • Somerset West, Western Cape, Sydafrika, 7130
        • Rekruttering
        • Clinical Trials Network Helderberg (Pty) Ltd
      • Brno, Tjekkiet, 656 91
        • Rekruttering
        • Fakultni nemocnice u sv. Anny v Brne
      • Dolní Břežany, Tjekkiet, 252 41
        • Rekruttering
        • Centrum zdraví Dolní Břežany, a.s.
      • Liberec, Tjekkiet, 460 01
        • Rekruttering
        • KARDIOLOGIE - LIBEREC s.r.o.
      • Náchod, Tjekkiet, 54701
        • Rekruttering
        • Interní a diabetologická ordinace s.r.o.
      • Plzeň 3, Tjekkiet, 301 00
        • Rekruttering
        • DIALINE s.r.o.
      • Prague, Tjekkiet, 149 00
        • Rekruttering
        • MILAN KVAPIL s.r.o.
      • Prague, Tjekkiet, 150 00
        • Rekruttering
        • EUC Klinika Praha a.s.
      • Prague, Tjekkiet, 160 00
        • Rekruttering
        • FLEDIP s.r.o.
      • Prague, Tjekkiet, 10400
        • Rekruttering
        • ENDOTRIAL s.r.o.
      • Baja, Ungarn, 6500
        • Rekruttering
        • EURÉKA-CENTER Orvosi és Szolgáltató Betéti Társaság
      • Biatorbágy, Ungarn, 2051
        • Rekruttering
        • Biatros Kft.
      • Budapest, Ungarn, 1083
        • Rekruttering
        • Semmelweis Egyetem
      • Budapest, Ungarn, H-1141
        • Rekruttering
        • Cardiogeneral Kft.
      • Békéscsaba, Ungarn, 5600
        • Rekruttering
        • Bekes Varmegyei Kozponti Korhaz
      • Békéscsaba, Ungarn, 5600
        • Rekruttering
        • Trial Pharma Kft.
      • Szolnok, Ungarn, 5000
        • Rekruttering
        • Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
      • Székesfehérvár, Ungarn, 8000
        • Ikke rekrutterer endnu
        • Mentaház Kft.
    • Bekes County
      • Békéscsaba, Bekes County, Ungarn, 5600
        • Rekruttering
        • Dr. Lakatos Ferenc Kardiológus ,Belgyógyász Magán szakrendelés
    • Bács-Kiskun county
      • Baja, Bács-Kiskun county, Ungarn, 6500
        • Rekruttering
        • Lausmed Kft.
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Ungarn, 6725
        • Rekruttering
        • Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
    • Pest County
      • Budapest, Pest County, Ungarn, 1036
        • Rekruttering
        • Óbudai Egészségügyi Centrum
      • Budapest, Pest County, Ungarn, 1213
        • Ikke rekrutterer endnu
        • Szatmári-Med Kft.
    • Szabolcs-Szatmár-Bereg
      • Nyíregyháza, Szabolcs-Szatmár-Bereg, Ungarn, 4400
        • Rekruttering
        • Medifarma-98 Kft.
      • Graz, Østrig, 8036
        • Rekruttering
        • Medical University of Graz
      • Mattersburg, Østrig, 7210
        • Rekruttering
        • Ordination Winhofer-Stöckl
      • Saint Stefan, Østrig, 8511
        • Rekruttering
        • Fließer-Görzer [Ordination]
      • Vienna, Østrig, 1090
        • Rekruttering
        • Universitätsklinikum AKH Wien
      • Vienna, Østrig, 1030
        • Rekruttering
        • Klinik Landstrasse
      • Vienna, Østrig, 1130
        • Rekruttering
        • Klinik Hietzing 3. Med. Abt.
      • Vienna, Østrig, 1180
        • Rekruttering
        • Itariu [Ordination]
      • Vienna, Østrig, 1120
        • Rekruttering
        • Ordination Dr. Günter Sokol

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria :

  • Male or female (sex assigned at birth, inclusive of all gender identities).
  • Age 18 years or above at the time of signing the informed consent.
  • BMI≥ 35.0 kg/m^2.
  • Participants without T2D: No history of T2D and HbA1c < 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c < 10% (< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.

Exclusion Criteria:

  • A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records.
  • Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cagrisema - dose level 1
Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Aktiv komparator: Cagrisema - dose level 2
Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Aktiv komparator: Semaglutide
Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.
Semaglutid vil blive administreret subkutant.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative change in body weight
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured as percentage (%).
From randomisation (week 0) to end of treatment (week 72)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Relative change in body weight
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured as %.
From randomisation (week 0) to end of treatment (week 72)
Change in Body Mass Index (BMI)
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured as kilograms per square metre (kg/m^2).
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve greater than or equal to (≥) 30% weight reduction
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve ≥25% weight reduction
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve greater ≥ 20% weight reduction
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
From randomisation (week 0) to end of treatment (week 72)
Change in waist circumference
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured in centimetre (cm).
From randomisation (week 0) to end of treatment (week 72)
Mean change in body weight
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured in kilograms (kg).
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve a BMI less than (<) 30 kg/m^2
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve BMI <27 kg/m^2
Tidsramme: end of treatment (week 72)
Measured as count of participants.
end of treatment (week 72)
Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2
Tidsramme: At end of treatment (week 72)
Measured as count of participants.
At end of treatment (week 72)
Number of participants who achieve a waist-to-height ratio < 0.53
Tidsramme: At end of treatment (week 72)
Measured as count of participants.
At end of treatment (week 72)
Ratio to baseline : Total cholesterol
Tidsramme: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : High density lipoprotein (HDL) cholesterol
Tidsramme: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Low density lipoprotein (LDL) cholesterol
Tidsramme: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol
Tidsramme: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Triglycerides
Tidsramme: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline: Free fatty acids
Tidsramme: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Ratio to baseline : Non-HDL cholesterol
Tidsramme: From baseline (week 0) to end of treatment (week 72)
Measured in terms of ratio.
From baseline (week 0) to end of treatment (week 72)
Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured as score on a scale. The SF-36v2 acute measures health-related quality of life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10. Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.
From randomisation (week 0) to end of treatment (week 72)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.
From randomisation (week 0) to end of treatment (week 72)
Change in glycated haemoglobin (HbA1c)
Tidsramme: From randomisation (week 0) to end of treatment (week 72)
Measured in %-points.
From randomisation (week 0) to end of treatment (week 72)
Number of participants who achieve HbA1c <6.5%
Tidsramme: At end of treatment (week 72)
Measured as count of participants.
At end of treatment (week 72)
Number of participants who achieve normal HbA1c <5.7%
Tidsramme: At end of treatment (week 72)
Measured as count of participants.
At end of treatment (week 72)
Number of treatment-emergent adverse events (TEAEs)
Tidsramme: From randomisation (week 0) to end of study (week 80)
Measured in number of events.
From randomisation (week 0) to end of study (week 80)
Number of treatment-emergent serious adverse events (TESAEs)
Tidsramme: From randomisation (week 0) to end of study (week 80)
Measured in number of events.
From randomisation (week 0) to end of study (week 80)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Studieleder: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. maj 2026

Primær færdiggørelse (Anslået)

23. februar 2028

Studieafslutning (Anslået)

19. april 2028

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

27. april 2026

Først opslået (Faktiske)

4. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • NN9838-7910
  • 2025 (U.S. NIH-bevilling/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • U1111-1323-0372 (Anden identifikator: World Health Organization)
  • 2025-522488-14 (Anden identifikator: European Medical Agency (EMA))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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