A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor
REIMAGINE 2
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
3 other identifiers
interventional
2,734
30 countries
390
Brief Summary
The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Sep 2023
Typical duration for phase_3 type-2-diabetes-mellitus
390 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2023
CompletedStudy Start
First participant enrolled
September 27, 2023
CompletedFirst Posted
Study publicly available on registry
October 4, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2026
CompletedJanuary 22, 2026
January 1, 2026
2.1 years
September 26, 2023
January 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c)
Measured in percentage-points.
From baseline (week 0) to end of treatment (week 68)
Secondary Outcomes (37)
CagriSema versus cagrilintide: Change in HbA1c
From baseline (week 0) to end of treatment (week 68)
CagriSema versus cagrilintide: Relative change in body weight
From baseline (week 0) to end of treatment (week 68)
CagriSema (dose 1) versus semaglutide (dose 2): Change in HbA1c
From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Relative change in body weight
From baseline (week 0) to end of treatment (week 68)
Cagrilintide versus placebo: Change in HbA1c
From baseline (week 0) to end of treatment (week 68)
- +32 more secondary outcomes
Study Arms (7)
CagriSema Dose 1
EXPERIMENTALParticipants will receive once-weekly subcutaneous (s.c) injections of cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.
CagriSema Dose 2
EXPERIMENTALParticipants will receive once-weekly s.c injections of cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.
Semaglutide Dose 1
ACTIVE COMPARATORParticipants will receive once-weekly s.c injection of semaglutide dose 1 for 68 weeks.
Semaglutide Dose 2
ACTIVE COMPARATORParticipants will receive once-weekly s.c injection of semaglutide dose 2 for 68 weeks.
Cagrilintide Dose 1
ACTIVE COMPARATORParticipants will receive once-weekly s.c injection of cagrilintide dose 1 for 68 weeks.
Placebo Dose 1
PLACEBO COMPARATORParticipants will receive once-weekly s.c injection of placebo matched to cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.
Placebo Dose 2
PLACEBO COMPARATORParticipants will receive once-weekly s.c injection of placebo matched to cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.
Interventions
Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose 1 and dose 2 of cagrilintide is reached.
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose 1 and dose 2 of semaglutide is reached.
Participants will receive placebo matched to cagrilintide subcutaneously.
Participants will receive placebo matched to semaglutide subcutaneously.
Eligibility Criteria
You may qualify if:
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.
- Stable daily dose(s) greater than or equal to 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.
- Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
- Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
You may not qualify if:
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by central laboratory at screening.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (405)
Synexus Clin Res-Birmingham
Birmingham, Alabama, 35211, United States
Univ of Alabama_Birmingham
Birmingham, Alabama, 35294, United States
Cahaba Research
Pelham, Alabama, 35124, United States
Velocity Clinical Research-Phoenix
Phoenix, Arizona, 85006, United States
Synexus Rsch /Cnt Phnx Med C
Phoenix, Arizona, 85020, United States
Arkansas Clinical Research
Little Rock, Arkansas, 72205, United States
Velocity Clinical Res-Banning
Banning, California, 92220, United States
Velocity Clin Res-Chula Vista
Chula Vista, California, 91911, United States
John Muir Physicians Network
Concord, California, 94520, United States
Headlands Research California, LLC
Escondido, California, 92025, United States
Velocity Clin Res Gardena
Gardena, California, 90247, United States
Velocity Clin Res San Diego
La Mesa, California, 91942, United States
Loma Linda Univ Hlth Cr Endo
Loma Linda, California, 92354, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, 91355, United States
Desert Oasis Hlthcr Med Group
Palm Springs, California, 92262, United States
Velocity Clin Res- San Bern
San Bernardino, California, 92408, United States
Linda Vista Health Care Ctr
San Diego, California, 92111, United States
Velocity Clin Res Santa Ana
Santa Ana, California, 92704, United States
Premier Medical Center, Inc.
Toluca Lake, California, 91602, United States
Velocity Clin Res - Panorama
Van Nuys, California, 91405, United States
Optumcare Clinical Trials,LLC-Golden
Colorado Springs, Colorado, 80906, United States
Northeast Research Institute
Jacksonville, Florida, 32204, United States
Clinical Trial Services Corp
Miami, Florida, 33144, United States
Bioclinical Research Alliance
Miami, Florida, 33155, United States
New Horizon Research Center
Miami, Florida, 33165, United States
South Broward Research LLC
Miramar, Florida, 33027, United States
West Orange Endocrinology
Ocoee, Florida, 34761, United States
Optimal Research Sites
Orange City, Florida, 32763, United States
Advent Health-Res Inst
Orlando, Florida, 32804, United States
AdventHealth Diab Inst
Orlando, Florida, 32804, United States
Synexus Clin Res - Orlando
Orlando, Florida, 32806, United States
Oviedo Medical Research, LLC
Oviedo, Florida, 32765, United States
Hope Clin Res & Wellness
Conyers, Georgia, 30094, United States
East Coast Institute for Res
Macon, Georgia, 31210, United States
Urban Family Practice Assoc
Marietta, Georgia, 30067, United States
Endocrine Research Solutions, Inc.
Roswell, Georgia, 30076, United States
Endocrine Research Solutions
Roswell, Georgia, 30076, United States
Pacific Diabetes & Endo Ctr
Honolulu, Hawaii, 96813, United States
St. Luke's Health System
Boise, Idaho, 83702, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Cedar-Crosse Research Center
Chicago, Illinois, 60607, United States
Clinical Invest Special_Gurnee
Gurnee, Illinois, 60031, United States
Endeavor Health
Skokie, Illinois, 60077, United States
Evanston Premier Hlthcr Res
Skokie, Illinois, 60077, United States
Iowa Diabetes & Endo Res Ctr
West Des Moines, Iowa, 50266, United States
Alliance for Multispec Res
Newton, Kansas, 67114, United States
Cotton-O'Neil Diab & Endo Ctr
Topeka, Kansas, 66606, United States
Velocity Clin Res Lafayette
Lafayette, Louisiana, 70508, United States
BTC of New Bedford, LLC
New Bedford, Massachusetts, 02740, United States
Velocity Clin Res Gulfport
Gulfport, Mississippi, 39503, United States
Diabetes & Endo Specialists Inc
Chesterfield, Missouri, 63017, United States
Premier Research Inc.
Trenton, New Jersey, 08611, United States
Velocity Clin Res Albuquerque
Albuquerque, New Mexico, 87107, United States
AMC Community Endocrinology
Albany, New York, 12203, United States
Velocity Clin Res Syracuse
East Syracuse, New York, 13057, United States
Southgate Medical Group, LLP
West Seneca, New York, 14224, United States
Great Lakes Medical Research
Westfield, New York, 14787, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408, United States
Carteret Medical Group
Morehead City, North Carolina, 28557, United States
Piedmont Healthcare/Research
Statesville, North Carolina, 28625, United States
Accellacare
Wilmington, North Carolina, 28401, United States
Radiant Research Inc. - Akron
Akron, Ohio, 44311, United States
Centricity Research
Columbus, Ohio, 43213, United States
Alliance for Multispec Res
Norman, Oklahoma, 73069, United States
Clinical Res Collaborative
Cumberland, Rhode Island, 02864, United States
Velocity Clin Res Providence
East Greenwich, Rhode Island, 02818, United States
AnMed Health IMA
Anderson, South Carolina, 29621, United States
Synexus Clin Res US-Anderson
Anderson, South Carolina, 29621, United States
Velocity Clinical Res-Anderson
Anderson, South Carolina, 29621, United States
Velocity Clin Res Gaffney
Gaffney, South Carolina, 29340, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681-1538, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Velocity Clin Res Spartanburg
Spartanburg, South Carolina, 29303, United States
Holston Medical Group Pc
Bristol, Tennessee, 37620-7352, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Clinical Research Associates
Nashville, Tennessee, 37203, United States
Arlington Family Res. Ctr Inc
Arlington, Texas, 76012-4637, United States
Velocity Clin Res Austin
Austin, Texas, 78759, United States
UT Health University of Texas
Bellaire, Texas, 77401, United States
Velocity Clinical Res-Dallas
Dallas, Texas, 75230, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
Synexus Clin Res Dallas
Dallas, Texas, 75234, United States
Cedar Health Research
Dallas, Texas, 75251, United States
JCCT- Juno NW Houston
Houston, Texas, 77040, United States
Synergy Groups Medical
Houston, Texas, 77061, United States
PlanIt Research, PLLC
Houston, Texas, 77079, United States
Medical Colleagues-Texas LLP
Katy, Texas, 77450, United States
Sante Clinical Research
Kerrville, Texas, 78028, United States
Discovery MMS Services, INC
Missouri City, Texas, 77459, United States
AES San Antonio
San Antonio, Texas, 78229, United States
University of Texas San Antonio
San Antonio, Texas, 78229, United States
NE Clin Res of San Antonio
San Antonio, Texas, 78233, United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231, United States
DM Clin Rsrch/Fam Diag Clinic
Tomball, Texas, 77375, United States
Diabetes & Endo Treatment Spec
Sandy City, Utah, 84093, United States
Velocity Clin Res-Salt Lk City
West Jordan, Utah, 84088, United States
TPMG Clinical Research
Newport News, Virginia, 23606, United States
Rainier Clin Res Ctr Inc
Renton, Washington, 98057, United States
St. Vincent Hosp-Prevea Health
Green Bay, Wisconsin, 54303, United States
Mautalen Salud e investigación
CABA, Buenos Aires, C1128 AAF, Argentina
Sanatorio Güemes
CABA, City of Buenos Aires, C1180AAX, Argentina
Instituto de Investigaciones Clínicas Rosario
Rosario, Santa Fe Province, S2000CUD, Argentina
STAT Research
Buenos Aires, C1023AAB, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires, C1425AGC, Argentina
Centro de Investigación y Prevención Cardiovascular
CABA, C1061AAS., Argentina
Charles Perkins Centre
Camperdown, New South Wales, 2050, Australia
Momentum Clinical Research Darlinghurst
Darlinghurst, New South Wales, 2010, Australia
Macquarie University
Macquarie Park, New South Wales, 2109, Australia
Hunter Diabetes Centre
Merewether, New South Wales, 2291, Australia
Logan Hospital
Meadowbrook, Queensland, 4131, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, 5046, Australia
St Vincent's Hospital - Melbourne
Fitzroy, Victoria, 3065, Australia
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004, Australia
Cline Research Center
Curitiba, Paraná, 80030-480, Brazil
CPQuali Pesquisa Clínica Ltda
São Paulo, São Paulo, 01228-000, Brazil
CPCLIN - Centro de Pesquisas Clínicas
São Paulo, São Paulo, 01228-200, Brazil
IPSMC - Dr. Nikolay Kostadinov EOOD
Burgas, 8000, Bulgaria
Dr. Tatyana Metalova - AIPSMCE EOOD
Gotse Delchev, 2900, Bulgaria
ASOMCEID - Individual Practice - Dr. Abdul-Azis EOOD
Kardzhali, 6600, Bulgaria
Medical Center Zdrave Lom EOOD
Lom, 3600, Bulgaria
Medical Centre Razgrad OOD
Razgrad, 7200, Bulgaria
DCC Ascendent OOD
Sofia, 1202, Bulgaria
Medical Center Maraya Med EOOD
Sofia, 1756, Bulgaria
Medical Centre - Clinic Nova EOOD
Varna, 9000, Bulgaria
Medical centre Clinic Nova
Varna, 9000, Bulgaria
UMHAT Sveta Marina EAD
Varna, 9010, Bulgaria
Centricity Research Calgary Endocrinology
Calgary, Alberta, T2H 2G4, Canada
Centricity Research Calgary
Calgary, Alberta, T2H 2G4, Canada
Synergy Wellness Clinic
Sherwood Park, Alberta, T8H 0N2, Canada
Guilford Med Clinic
Surrey, British Columbia, V3R 4H6, Canada
TLC Diabetes and Endocrinology
Surrey, British Columbia, V3T 2V6, Canada
Ocean West Research Clinic
Surrey, British Columbia, V3Z 2N6, Canada
Hilltop Medical Clinic
Surrey, British Columbia, V4A 0C1, Canada
Spectrum Health Clinic
Vancouver, British Columbia, V6Z 2T1, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, E1G 1A7, Canada
Centricity Res. Barrie Endo
Barrie, Ontario, L4N 7L3, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, L6S 0C6, Canada
Centricity Research Vaughn Endocrinology
Concord, Ontario, L4K 4M2, Canada
Medical Trust Clinics, Inc.
Courtice, Ontario, L1E2J5, Canada
Centricity Research Etobicoke Endocrinology
Etobicoke, Ontario, M9R 4E1, Canada
Milestone Research
London, Ontario, N5W 6A2, Canada
Western Univ. Cnt for Studies in Fam Med
London, Ontario, N6G 2M1, Canada
My Endo Diabetes & Endo Cent
Markham, Ontario, L3P 7P2, Canada
Centricity Research Ottawa LMC
Nepean, Ontario, K2J 0V2, Canada
Centricity Research Oshawa
Oshawa, Ontario, L1J 2K9, Canada
Centricity Research Toronto
Toronto, Ontario, M4G 3E8, Canada
Diabetes Heart Research Centre
Toronto, Ontario, M6G 1M2, Canada
Centre Medical Acadie
Montreal, Quebec, H4N 2W2, Canada
Centricity Res Pointe-Claire
Pointe-Claire, Quebec, H9R 4S3, Canada
ALPHA Recherche Clinique
Québec, Quebec, G3K 2P8, Canada
LMC Clin Rsrch Inc. (Montreal)
Saint-Laurent, Quebec, H4T 1Z9, Canada
Q & T Research Sherbrooke Inc.
Sherbrooke, Quebec, J1J 2G2, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, J6X 4P7, Canada
Diex Recherche Victoriaville
Victoriaville, Quebec, G6P 3Z8, Canada
Diex Recherche Quebec Inc.
Québec, G1V 4T3, Canada
Clin des Mal Lipid de Quebec
Québec, G1V 4W2, Canada
Centre de Recherche Saint-Louis
Québec, G1W 4R4, Canada
Beijing Friendship Hospital, Capital Medical University-Endocrinology
Beijing, Beijing Municipality, 100050, China
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, 100853, China
Chongqing University Three Gorges Hospital
Chongqing, Chongqing Municipality, 404000, China
Huaihe Hospital of Henan University-Endocrinology
Kaifeng, Henan, 475000, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, 210011, China
Suzhou Municipal Hospital-Endocrinology
Suzhou, Jiangsu, 215002, China
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, 212001, China
Jinan Central Hospital
Ji'Nan, Shandong, 250000, China
Jinan Central Hospital
Jinan, Shandong, 250000, China
FOSCAL
Floridablanca, Santander Department, 681004, Colombia
Cimedical
Barranquilla, 80001, Colombia
Clinica Imbanco SAS
Cali, 760042, Colombia
IMAT - Oncomedica
Montería, 230001, Colombia
Poliklinika Solmed
Zagreb, City of Zagreb, 10000, Croatia
Poliklinika SLAVONIJA OSIJEK
Osijek, County of Osijek-Baranja, 31000, Croatia
Clinical Hospital Centre Rijeka_Endocrinology
Rijeka, Primorje-Gorski Kotar County, 51 000, Croatia
Specijalna bolnica Thalassotherapia
Opatija, 51 410, Croatia
General Hospital Dr. Josip Bencevic_Diabetic department
Slavonski Brod, 35 000, Croatia
Opca bolnica Varazdin_Endocrinology
Varaždin, 42 000, Croatia
IKEM Centrum Diabetologie
Prague, Czech Republic, 140 21, Czechia
Fakultní nemocnice U sv. Anny v Brně
Brno, 602 00, Czechia
Edumed Broumov
Broumov, 550 01, Czechia
Diahaza s.r.o.
Holešov, 76901, Czechia
DIALINE s.r.o.
Plzeň 3, 301 00, Czechia
Diabet2 s.r.o.
Prague, 110 00, Czechia
MUDr. Michala Pelikanova
Prague, 140 00, Czechia
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus N, 8200, Denmark
Bispebjerg Hospital, IC-Forskning
Copenhagen, 2400, Denmark
Steno Diabetes Center Copenhagen
Herlev, 2730, Denmark
Hillerød Endokrinologisk amb. H0652
Hillerød, 3400, Denmark
Hvidovre Hospital Endokrinologisk forsk. afs. 159
Hvidovre, 2650, Denmark
Steno Diabetes Center Odense
Odense C, 5000, Denmark
Terveystalo Jyväskylä
Jyväskylä, 40100, Finland
Seinäjoen keskussairaala
Seinäjoki, 60220, Finland
Pihlajalinna Koskiklinikka
Tampere, 33100, Finland
Terveystalo Tampere Rautatienkatu
Tampere, 33100, Finland
Turku University Hospital
Turku, 20520, Finland
Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
Berlin, 13597, Germany
Diabetologische Schwerpunktpraxis Daaden
Daaden, 57567, Germany
Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
Dortmund, 44137, Germany
Uniklinik TU Dresden - Med. Klinik III
Dresden, 01307, Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH
Elsterwerda, 04910, Germany
InnoDiab Forschung GmbH
Essen, 45136, Germany
MVZ Diabeteszentrum Dr. Tews GmbH
Gelnhausen, 63571, Germany
Diabetes-Zentrum-Wilhelmsburg GbR
Hamburg, 21109, Germany
Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
Hamburg, 22041, Germany
Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
Lingen, 49808, Germany
Die Praxis am Ludwigsplatz
Ludwigshafen, 67059, Germany
Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck
Lübeck, 23538, Germany
Medicover Neuroendokrinologie MVZ München
München, 81667, Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, 23758, Germany
Praxis für Innere Medizin - Zwenkau
Zwenkau, 04442, Germany
University Hospital of Athens ATTIKON
Athens, Attica, 12462, Greece
General Hospital Of Thessaloniki Papageorgiou
Nea Efkarpia, Thessaloniki, 56429, Greece
Iatriko Psychicou Private Clinic
Athens, 115 25, Greece
"Laiko" General Hospital of Athens
Athens, 11527, Greece
General hospital of Athens 'G.Gennimatas'
Athens, 11527, Greece
Iatriko Athinon (Athens Medical Canter)
Athens, 15125, Greece
Univ Gen Hospital Larisa
Larissa, 41110, Greece
"AHEPA" University Hospital of Thessaloniki
Thessaloniki, 54621, Greece
NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
Thessaloniki, 54635, Greece
"AHEPA" University Hospital of Thessaloniki
Thessaloniki, 54636, Greece
"Ippokrateio" G.H. of Thessaloniki
Thessaloniki, 54642, Greece
Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
Szeged, Csongrád-Csanád, 6725, Hungary
Debreceni Egyetem Belgyógyászati Klinika
Debrecen, Hajdú-Bihar, 4032, Hungary
Óbudai Egészségügyi Centrum
Budapest, Pest County, 1036, Hungary
Bajcsy-Zsilinszky Kórház
Budapest, 1106, Hungary
MH Egészségügyi Központ
Budapest, 1134, Hungary
Kaposi Mór Oktató Kórház
Kaposvár, 7400, Hungary
Kanizsai Dorottya Kórház
Nagykanizsa, 8800, Hungary
Vas Vármegyei Markusovszky Egyetemi Oktatókórház
Szombathely, 9700, Hungary
Zala Megyei Szent Rafael Kórház
Zalaegerszeg, 8900, Hungary
Yalamanchi Hospitals and Research centres pvt ltd
Vijaywada, Andhra Pradesh, 520002, India
Gauhati Medical College and Hospital
Guwahati, Assam, 781032, India
Swasthya Diabetes Care
Ahmedabad, Gujarat, 390013, India
Lifecare Hospital and Research Centre
Bengaluru, Karnataka, 560066, India
K R Hospital
Mysuru, Karnataka, 570001, India
BYL Nair Hospital and T N Medical College Department of endo
Mumbai, Maharashtra, 400008, India
Ashirwad Hospital and Research Centre
Thane, Maharashtra, 421004, India
SMS Medical College & Hospital
Jaipur, Rajasthan, 302004, India
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086, India
KG Hospital
Coimbatore, Tamil Nadu, 641018, India
Gleneagles Hospitals
Hyderabad, Telangana, 500004, India
Dr P V Rao - Diabetes Research Centre
Hyderabad, Telangana, 50082, India
Apollo Multispeciality Hospital, Kolkata
Kolkata, West Bengal, 700054, India
Post Graduate Institute of Medical Education & Research
Chandigarh, 160012, India
Lady Hardinge Medical College
New Delhi, 110001, India
Clalit sick fund Herzeliya
Herzeliya, Israel, 4630945, Israel
Linn clinic - Clalit Health Services
Haifa, 35152, Israel
Linn clinic - Diabetes Unit
Haifa, 35152, Israel
Clalit sick fund Herzlia
Herzliya, 4630945, Israel
Wolfson MC - Diabetes Clinic
Holon, 58100, Israel
Hadassah Ein Karam MC - Diabetes Unit
Jerusalem, 91120, Israel
Kaplan MC - Metabolic Unit
Rehovot, 76100, Israel
Kaplan MC
Rehovot, 76100, Israel
Sheba MC - Endocrinology Clinic
Tel Litwinsky, 52621, Israel
AOU Careggi Firenze
Florence, Fi, 50134, Italy
Istituto Scientifico San Raffaele
Milan, MI, 20132, Italy
AOU Careggi Firenze
Florence, Tuscany, 50134, Italy
Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato
Arezzo, 52100, Italy
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24127, Italy
Azienda Ospedaliero-Universitaria Renato Dulbecco
Catanzaro, 88100, Italy
Università degli studi G. D'Annunzio Chieti Pescara - CAST
Chieti Scalo, 66100, Italy
Azienda Ospedaliera Luigi Sacco
Milan, 20157, Italy
Azienda Ospedaliera Universitaria Federico II di Napoli
Naples, 80131, Italy
AOUP Giaccone Palermo
Palermo, 90127, Italy
Dip. di Medicina Interna Policlinico Universitario Palermo
Palermo, 90127, Italy
Azienda Ospealiero Universitaria Policlinico Umberto I
Roma, 00161, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche
Rome, 00168, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Civile Maggiore Borgo Trento
Verona, 37126, Italy
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, Fukushima, Japan, 963-8851, Japan
Abe Diabetes Clinic_Internal Medicine
Ōita, Oita, Japan, 870 0039, Japan
Akaicho Clinic
Chiba-shi, Chiba, 260-0804, Japan
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113, Japan
Naka Kinen Clinic
Ibaraki, 311-0113, Japan
Minami Akatsuka Clinic
Mito-shi, Ibaraki, 311-4153, Japan
Medical Research Institute KITANO HOSPITAL_Diabetes & Endocrinology
Osaka-shi, Osaka, 530-8480, Japan
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027, Japan
Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031, Japan
Fukuwa Clinic
Tokyo, 104-0031, Japan
Centro de investigación en Artritis y Osteoporosis S.C.
Mexicali, Estado de Baja California, 21200, Mexico
InstitutoJalisciense de Investigación en Diabetes y Obesidad
Guadalajara, Jalisco, 44600, Mexico
Centro de Investigacion Clinica Endocrinologica de Jalisco
Guadalajara, Jalisco, 44670, Mexico
Centro de Estudios de Investigación Metabólicos y Cardio
Ciudad Madero, Tamaulipas, 89440, Mexico
Malopolskie Centrum Sercowo-Naczyniowe
Chrzanów, Lesser Poland Voivodeship, 32-500, Poland
Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
Gorzów Wielkopolski, Lubusz Voivodeship, 66-400, Poland
Prywatna Praktyka Lekarska Anna Chudoba
Żyrardów, Masovian Voivodeship, 96-300, Poland
Instytut Diabetologii Sp. z o.o.
Warsaw, Mazovian Voivodeship, 02-117, Poland
Centrum Medyczne Medyk Sp. z o.o.
Rzeszów, Podkarpackie Voivodeship, 35-055, Poland
Osteo Medic s.c. Artur Racewicz Jerzy Supronik
Bialystok, Podlaskie Voivodeship, 15-351, Poland
NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
Bialystok, Podlaskie Voivodeship, 15-435, Poland
PAKS III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Dąbrowa Górnicza, Silesian Voivodeship, 41-300, Poland
PAKS III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Tychy, Silesian Voivodeship, 43-100, Poland
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz, 85-796, Poland
PAKS III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
Dąbrowa Górnicza, 41-300, Poland
Velocity Nova Sp. z o.o.
Lublin, 20-362, Poland
KO-MED Centra Kliniczne Sp. z o.o.
Puławy, 24-100, Poland
Velocity Nova Sp. z o.o.
Staszów, 28-200, Poland
NBR Polska Tomasz Klodawski
Warsaw, 00-710, Poland
Instytut Diabetologii Sp. z o.o.
Warsaw, 02-117, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, 02-507, Poland
Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskich Klinik Serca
Zgierz, 95-100, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
Lodz, Łódź Voivodeship, 93-513, Poland
Velocity Nova Sp. z o.o.
Staszów, Świętokrzyskie Voivodeship, 28-200, Poland
Cabinet Medical Individual Dr. Ramona Dragut SRL
Piteşti, Argeş, 110283, Romania
Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
Bucharest, Bucurestii, 020475, Romania
Spitalul Clinic Judetean Urgenta Cluj-Napoca
Cluj-Napoca, Cluj, 400006, Romania
Poli Cardinal Med Srl
Reghin, Mureș County, 545300, Romania
Diabmed Dr Popescu Alexandrina SRL
Ploieşti, Prahova, 100179, Romania
CMI Dr. Busegeanu Mihaela Magdalena
Ploieşti, Prahova, 100342, Romania
Cabinet Medical de Diabet, Nutritie si Boli Metabolice-Dr. Zaharie Daniela Gabriela
Zalău, Sălaj County, 450112, Romania
CMI Dr. Pletea Noemi SRL
Bacau, 600154, Romania
Mariodiab Clinic SRL
Brasov, 500101, Romania
Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
Brasov, 500283, Romania
Diabet Med SRL
Bucharest, 050913, Romania
Urodiamed SRL
Craiova, 200349, Romania
S.C Milena Sante SRL
Galati, 800001, Romania
Gama Diamed Srl
Mangalia, 905500, Romania
Bella Praxis S.R.L.
Paşcani, 705200, Romania
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
Novi Sad, Vojvodina, 21000, Serbia
CHC Zvezdara, Clinical department for endocrinology
Belgrade, 11000, Serbia
Endocrinology, Diabetes and Metabolism Diseases Clinic
Belgrade, 11000, Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, 11080, Serbia
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
Kragujevac, 34000, Serbia
Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr
Kragujevac, 34000, Serbia
DIADA, s.r.o.
Bardejov, 08501, Slovakia
Diabetologicka ambulancia DIOLI s.r.o.
Košice, 040 01, Slovakia
DIOLI s.r.o.
Košice, 040 01, Slovakia
MediVet s.r.o.
Malacky, 90101, Slovakia
DIALIPID, s.r.o.
Prešov, 080 01, Slovakia
MUDr. Jan Culak, s.r.o.
Prievidza, 971 01, Slovakia
DIACENTRUM, s.r.o.
Ružomberok, 034 01, Slovakia
MEDI-DIA s.r.o.
Sabinov, 083 01, Slovakia
DEImedi, s. r. o.
Šurany, 942 01, Slovakia
ARETEUS s.r.o.
Trebišov, 075 01, Slovakia
iDia s. r. o.
Žiar nad Hronom, 965 01, Slovakia
Healthcare centre Kocevje
Kočevje, 1330, Slovenia
Healthcare Centre Koper
Koper, 6000, Slovenia
Dermatologija Bartenjev
Ljubljana, 1000, Slovenia
UKC Ljubljana, Endocrinology and Diabetes
Ljubljana, 1000, Slovenia
UKC Maribor - diabetes
Maribor, 2000, Slovenia
Healthcare Centre Nova Gorica
Nova Gorica, 5000, Slovenia
General Hospital Nova Gorica_Diabetes
Šempeter pri Gorici, 5290, Slovenia
Hospital Topolšica
Topolšica, 3326, Slovenia
Phoenix Pharma
Port Elizabeth, Eastern Cape, 6001, South Africa
Newtown Clinical Research
Johannesburg, Gauteng, 2001, South Africa
Sandton Medical Research
Johannesburg, Gauteng, 2196, South Africa
Clinresco Centres (Pty) Ltd
Kempton Park, Gauteng, 1619, South Africa
Clinical Trial Systems (CTC)
Pretoria, Gauteng, 0186, South Africa
Paarl Research Centre
Paarl, Cape Town, Western Cape, 7646, South Africa
The Catholic University of Korea, Bucheon ST. Mary's Hospital
Bucheon-si, Gyeonggi-do, 14647, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Chosun University Hospital
Gwangju, 501-717, South Korea
Kyunghee University Medical Center
Seoul, 02447, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Vall d'Hebron
Barcelona, 08035, Spain
ABS La Roca del Vallés_Endocrinología
La Roca Del Vallés, 08430, Spain
Hospital Universitario de Móstoles
Móstoles, 28935, Spain
Hospital Son Llatzer
Palma de Mallorca, 07198, Spain
Hospital General de Segovia
Segovia, 40002, Spain
Hospital Infanta Luisa
Seville, 41010, Spain
Hospital La Fe - Endocrinología y Nutrición
Valencia, 46026, Spain
CTC EbbePark Linköping
Linköping, 582 13, Sweden
Clemenstorgets Hjärtmottagning
Lund, 222 21, Sweden
Endokrinologkliniken, Lund
Lund, 222 42, Sweden
Forskningsmottagning Internmedicin (tidigare KFE)
Malmo, 205 02, Sweden
CTC GoCo Mölndal
Mölndal, 431 53, Sweden
Örebro UH - Överviktsenheten
Örebro, 701 85, Sweden
Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl
Stockholm, 171 64, Sweden
Changhua Christian Hospital_Metabolic Dept.
Changhua, 500, Taiwan
Taipei Medical University Hospital
Taipei, 110, Taiwan
Cukurova Universitesi Tip Fakultesi
Adana, 01790, Turkey (Türkiye)
Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Endokrinoloji
Adana, 01790, Turkey (Türkiye)
Akdeniz University Tip Fakultesi Hastanesi
Antalya, 07058, Turkey (Türkiye)
Akdeniz Üniversitesi Hastanesi- Endokrinoloji
Antalya, 07058, Turkey (Türkiye)
Eskisehir Osmangazi University School of Medicine
Eskişehir, 26040, Turkey (Türkiye)
Eskişehir Osmangazi Üniversitesi Sağlık, Uygulama ve Araştırma Hastanesi
Eskişehir, 26040, Turkey (Türkiye)
Haseki Eğitim ve Araştırma Hastanesi- Dahiliye
Istanbul, 34098, Turkey (Türkiye)
Haseki Sultangazi
Istanbul, 34098, Turkey (Türkiye)
Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi
Istanbul, 34371, Turkey (Türkiye)
Şişli Hamidiye Etfal Eğitim ve Araştırma Hastanesi- Seyrantepe Yerleşkesi- Endokrinoloji
Istanbul, 34371, Turkey (Türkiye)
Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji
Istanbul, 34390, Turkey (Türkiye)
İstanbul Üniversitesi İstanbul Tıp Fakültesi Hastanesi- Endokrinoloji
Istanbul, 34390, Turkey (Türkiye)
Basaksehir Cam ve Sakura Sehir Hastanesi
Istanbul, 34480, Turkey (Türkiye)
Başakşehir Çam ve Sakura Şehir Hastanesi
Istanbul, 34480, Turkey (Türkiye)
Göztepe Prof. Dr.Süleyman Yalçın Şehir Hastanesi- Dahiliye
Istanbul, 34722, Turkey (Türkiye)
T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
Istanbul, 34722, Turkey (Türkiye)
Recep Tayyip Erdoğan Üni. Eğitim ve Araştırma Hastanesi
Rize, 53020, Turkey (Türkiye)
Recep Tayyip Erdoğan Üniversitesi EAH-Endokrinoloji
Rize, 53020, Turkey (Türkiye)
Tekirdag Namık Kemal UTF
Tekirdağ, 59030, Turkey (Türkiye)
Tekirdağ Namık Kemal Üniversitesi Hastanesi- Dahiliye
Tekirdağ, 59030, Turkey (Türkiye)
Lister Hospital
Stevenage, Hertfordshire, SG1 4AB, United Kingdom
Pickering Medical Practice
Pickering, North Yorkshire, YO18 8BL, United Kingdom
Aberdeen Royal Infirmary - Diabetes
Aberdeen, AB25 2ZP, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, AB25 2ZP, United Kingdom
Oldfield Surgery
Bath, BA2 3HT, United Kingdom
Oakenhurst Medical Practice
Blackburn, BB2 1AX, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Aintree University Hospital
Liverpool, L9 7AL, United Kingdom
Norfolk and Norwich University Hospital Trust
Norwich, NR4 7UY, United Kingdom
Moorgreen Hospital
Southampton, SO30 3JB, United Kingdom
Joint Clinical Research Facility - Swansea
Swansea, SA2 8PP, United Kingdom
Royal Cornwall Hospital (Treliske)
Truro, TR1 3LJ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2023
First Posted
October 4, 2023
Study Start
September 27, 2023
Primary Completion
November 19, 2025
Study Completion
January 6, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com