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)

January 21, 2026 updated by: Novo Nordisk A/S

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

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).

Study Overview

Status

Completed

Conditions

Type 2 Diabetes Mellitus

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2734

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.
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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CagriSema Dose 1 Participants will receive once-weekly subcutaneous (s.c) injections of cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.	Drug: Cagrilintide 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. Drug: Semaglutide 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.
Experimental: CagriSema Dose 2 Participants will receive once-weekly s.c injections of cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.	Drug: Cagrilintide 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. Drug: Semaglutide 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.
Active Comparator: Semaglutide Dose 1 Participants will receive once-weekly s.c injection of semaglutide dose 1 for 68 weeks.	Drug: Semaglutide 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.
Active Comparator: Semaglutide Dose 2 Participants will receive once-weekly s.c injection of semaglutide dose 2 for 68 weeks.	Drug: Semaglutide 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.
Active Comparator: Cagrilintide Dose 1 Participants will receive once-weekly s.c injection of cagrilintide dose 1 for 68 weeks.	Drug: Cagrilintide 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.
Placebo Comparator: Placebo Dose 1 Participants will receive once-weekly s.c injection of placebo matched to cagrilintide dose 1 and semaglutide dose 1 for 68 weeks.	Drug: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. Drug: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.
Placebo Comparator: Placebo Dose 2 Participants will receive once-weekly s.c injection of placebo matched to cagrilintide dose 2 and semaglutide dose 2 for 68 weeks.	Drug: Placebo cagrilintide Participants will receive placebo matched to cagrilintide subcutaneously. Drug: Placebo semaglutide Participants will receive placebo matched to semaglutide subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CagriSema (dose 1) versus semaglutide (dose 1): Change in glycated haemoglobin (HbA1c) Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 27, 2023

Primary Completion (Actual)

November 19, 2025

Study Completion (Actual)

January 6, 2026

Study Registration Dates

First Submitted

September 26, 2023

First Submitted That Met QC Criteria

September 26, 2023

First Posted (Actual)

October 4, 2023

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NN9388-4896
U1111-1283-0427 (Other Identifier: World Health Organization (WHO))
2022-502678-18 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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CagriSema versus cagrilintide: Change in HbA1c Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus cagrilintide: Relative change in body weight Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage.	From baseline (week 0) to end of treatment (week 68)
CagriSema (dose 1) versus semaglutide (dose 2): Change in HbA1c Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Relative change in body weight Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage.	From baseline (week 0) to end of treatment (week 68)
Cagrilintide versus placebo: Change in HbA1c Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
Cagrilintide versus placebo: Relative change in body weight Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Achievement of greater than or equal to (>=) 10 percent (%) weight reduction Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Achievement of >= 15 % weight reduction Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Achievement of >= 20 % weight reduction Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: CGM - Change in time in Tight Target Range (TITR) 3.9-7.8 (mmol/L) (70-140 mg/dL) Time Frame: From baseline (week -3) to end of treatment (week 68)	Measured in percentage-points.	From baseline (week -3) to end of treatment (week 68)
CagriSema versus semaglutide: Change in Systolic Blood Pressure (SBP) Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in millimeters of mercury (mmHg).	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Ratio to baseline in triglycerides Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as ratio of triglycerides.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Ratio to baseline in non-High Density Lipoprotein (HDL) cholesterols Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as ratio of non-HDL cholesterol.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: CGM - Change in Time In Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Time Frame: From baseline (week -3) to end of treatment (week 68)	Measured in percentage-points.	From baseline (week -3) to end of treatment (week 68)
CagriSema versus semaglutide: Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP) Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as ratio of hsCRP.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Change in Fasting Plasma Glucose (FPG) Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in mmol/L.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Achievement of HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]) Time Frame: At end of treatment (week 68)	Measured as count of participants.	At end of treatment (week 68)
CagriSema versus semaglutide: Achievement of HbA1c target values of less than or equal to (≤)6.5% (≤48 mmol/mol) Time Frame: At end of treatment (week 68)	Measured as count of participants.	At end of treatment (week 68)
CagriSema versus semaglutide: CGM - Change in time above range, >10.0 mmol/L (>180 mg/dL) Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: CGM - Change in time above range, >13.9 mmol/L (>250 mg/dL) Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage-points.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: CGM - Within-day glycaemic variability (% coefficient of variation [CV]) Time Frame: At end of treatment (week 68)	Measured in percentage.	At end of treatment (week 68)
CagriSema versus semaglutide: Achievement of ≥ 5 % weight reduction Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as count of participants.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Change in waist circumference Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in centimetre.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Change in Diastolic Blood Pressure (DBP) Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in mmHg.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Ratio to baseline in total cholesterol Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as ratio of total cholesterol.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Ratio to baseline in HDL cholesterol Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as ratio of HDL cholesterol.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Ratio to baseline in low-density lipoprotein (LDL) cholesterol Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as ratio of LDL cholesterol.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Ratio to baseline in very low-density lipoprotein (VLDL) cholesterol Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as ratio of VLDL.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Ratio to baseline in free fatty acids Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured as ratio of free fatty acids.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Change in Short Form (SF)-36v score- Physical component summary score Time Frame: From baseline (week 0) to end of treatment (week 68)	SF-36v2 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 US general population has a mean of 50 and an standard deviation of 10. Physical component summary score range from 6.1 to 79.7, with higher scores indicating better functional health and well-being.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Change in SF-36v2 score- Mental component summary score Time Frame: From baseline (week 0) to end of treatment (week 68)	SF-36v2 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 US general population has a mean of 50 and an standard deviation of 10. Mental component summary score range from -3.8 to 78.7, with higher scores indicating better functional health and well-being.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score Time Frame: From baseline (week 0) to end of treatment (week 68)	DTSQc measures treatment satisfaction and diabetes-specific quality of life (QoL). The measure consists of 8 items yielding 1 global score and 2 single item scores. Total treatment satisfaction scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide: Change in Treatment Related Impact Measure for Diabetes (TRIM-D) score Time Frame: From baseline (week 0) to end of treatment (week 68)	TRIM-D measures impact of diabetes treatment. The measure consists of 28 items yielding 5 domain scores and a total score. The scores were transformed to a 0-100 scale with higher scores indicating a better health state.	From baseline (week 0) to end of treatment (week 68)
CagriSema versus semaglutide, placebo and cagrilintide: Number of treatment emergent adverse events (TEAEs) Time Frame: From baseline (week 0) to end of study (week 75)	Measured as count of events.	From baseline (week 0) to end of study (week 75)
CagriSema versus semaglutide: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) Time Frame: From baseline (week 0) to end of study (week 75)	Measured as count of episodes.	From baseline (week 0) to end of study (week 75)
CagriSema versus semaglutide: Number of severe hypoglycaemic episodes (level 3) Time Frame: From baseline (week 0) to end of study (week 75)	Measured as count of episodes. Hypoglycaemia episodes (level 3) are the episodes associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold.	From baseline (week 0) to end of study (week 75)

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)

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