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)
April 24, 2024 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
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
2700
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 Contact
- Name: Novo Nordisk
- Phone Number: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Study Locations
-
-
-
Buenos Aires, Argentina, C1023AAB
- Recruiting
- STAT Research
-
Buenos Aires, Argentina, C1425AGC
- Recruiting
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
-
Caba, Argentina, C1061AAS.
- Recruiting
- Centro de Investigación y Prevención Cardiovascular
-
-
Buenos Aires
-
Caba, Buenos Aires, Argentina, C1128 AAF
- Recruiting
- Mautalen Salud e Investigación
-
-
City Of Buenos Aires
-
Caba, City Of Buenos Aires, Argentina, C1180AAX
- Recruiting
- Sanatorio Güemes
-
-
Santa Fe
-
Rosario, Santa Fe, Argentina, S2000CUD
- Recruiting
- Instituto de Investigaciones Clinicas Rosario
-
-
-
-
New South Wales
-
Camperdown, New South Wales, Australia, 2050
- Recruiting
- Clinical Research Facility, Charles Perkins Centre
-
Darlinghurst, New South Wales, Australia, 2010
- Recruiting
- Holdsworth House Clinical Research
-
Macquarie Park, New South Wales, Australia, 2109
- Recruiting
- Macquarie University
-
Merewether, New South Wales, Australia, 2291
- Recruiting
- Hunter Diabetes Centre
-
-
Queensland
-
Meadowbrook, Queensland, Australia, 4131
- Recruiting
- Logan Hospital
-
-
South Australia
-
Oaklands Park, South Australia, Australia, 5046
- Recruiting
- Southern Adelaide Diabetes & Endocrine Services
-
-
Victoria
-
Fitzroy, Victoria, Australia, 3065
- Recruiting
- St Vincent's Hospital - Melbourne
-
Melbourne, Victoria, Australia, 3004
- Recruiting
- Baker IDI Heart and Diabetes Institute
-
-
-
-
Parana
-
Curitiba, Parana, Brazil, 80030-480
- Recruiting
- Cline Research Center
-
-
Sao Paulo
-
São Paulo, Sao Paulo, Brazil, 01228-000
- Recruiting
- CPQuali Pesquisa Clínica Ltda
-
São Paulo, Sao Paulo, Brazil, 01228-200
- Recruiting
- CPCLIN - Centro de Pesquisas Clínicas
-
-
-
-
-
Burgas, Bulgaria, 8000
- Recruiting
- "IPSMC - d-r Nikolay Kostadinov" EOOD
-
Gotse Delchev, Bulgaria, 2900
- Recruiting
- "Dr Tatyana Metalova - ambulatory for individual practice for specialised medical care for endocrinology" EOOD
-
Kardzhali, Bulgaria, 6600
- Not yet recruiting
- Ambulatory for specialised outpatient medical care for Endocrinology and Internal diseases - Individual Practice - Dr Abdul-Aziz
-
Lom, Bulgaria, 3600
- Recruiting
- Medical Center Zdrave Lom
-
Razgrad, Bulgaria, 7200
- Recruiting
- Medical centre Razgrad OOD
-
Sofia, Bulgaria, 1202
- Recruiting
- Diagnostic Consulting Center Ascendent
-
Sofia, Bulgaria, 1756
- Recruiting
- "Medical Center Maraya Med" EOOD
-
Varna, Bulgaria, 9010
- Recruiting
- UMHAT Sveta Marina EAD
-
Varna, Bulgaria, 9000
- Recruiting
- Medical centre Clinic Nova
-
-
-
-
-
Quebec, Canada, G1V 4T3
- Recruiting
- Diex Recherche Quebec Inc.
-
Quebec, Canada, G1W 4R4
- Recruiting
- Centre de Recherche Saint-Louis
-
Quebec, Canada, G1V 4W2
- Recruiting
- Clin des Mal Lipid de Quebec
-
-
Alberta
-
Calgary, Alberta, Canada, T2H 2G4
- Recruiting
- Centricity Research Calgary
-
Sherwood Park, Alberta, Canada, T8H 0N2
- Recruiting
- Synergy Wellness Clinic
-
-
British Columbia
-
Surrey, British Columbia, Canada, V3T 2V6
- Not yet recruiting
- TLC Diabetes and Endocrinology
-
Surrey, British Columbia, Canada, V3Z 2N6
- Recruiting
- Ocean West Research Clinic
-
Surrey, British Columbia, Canada, V4A 0C1
- Recruiting
- Hilltop Medical Clinic
-
Surrey, British Columbia, Canada, V3R 4H6
- Recruiting
- Guilford Med Clinic
-
Vancouver, British Columbia, Canada, V6Z 2T1
- Recruiting
- Spectrum Health Clinic
-
-
New Brunswick
-
Moncton, New Brunswick, Canada, E1G 1A7
- Recruiting
- G.A. Research Associates Ltd.
-
-
Ontario
-
Barrie, Ontario, Canada, L4N 7L3
- Recruiting
- Centricity Res. Barrie Endo
-
Brampton, Ontario, Canada, L6S 0C6
- Recruiting
- Centricity Research Brampton
-
Concord, Ontario, Canada, L4K 4M2
- Recruiting
- Centricity Research Vaughn
-
Courtice, Ontario, Canada, L1E2J5
- Recruiting
- Medical Trust Clinics, Inc.
-
Etobicoke, Ontario, Canada, M9R 4E1
- Recruiting
- Centricity Research Etobicoke
-
London, Ontario, Canada, N5W 6A2
- Recruiting
- Milestone Research
-
London, Ontario, Canada, N6G 2M1
- Not yet recruiting
- Western Univ. Cnt for Studies in Fam Med
-
Markham, Ontario, Canada, L3P 7P2
- Withdrawn
- My Endo Diabetes & Endo Cent
-
Nepean, Ontario, Canada, K2J 0V2
- Recruiting
- Centricity Research Ottawa LMC
-
Oshawa, Ontario, Canada, L1J 2K9
- Recruiting
- Centricity Research Oshawa
-
Toronto, Ontario, Canada, M6G 1M2
- Recruiting
- Diabetes Heart Research Centre
-
Toronto, Ontario, Canada, M4G 3E8
- Recruiting
- Centricity Research Toronto
-
-
Quebec
-
Montreal, Quebec, Canada, H4N 2W2
- Recruiting
- Centre Medical Acadie
-
Pointe-Claire, Quebec, Canada, H9R 4S3
- Recruiting
- Centricity Res Pointe-Claire
-
Quebec City, Quebec, Canada, G3K 2P8
- Recruiting
- ALPHA Recherche Clinique
-
Saint-Laurent, Quebec, Canada, H4T 1Z9
- Withdrawn
- LMC Clin Rsrch Inc. (Montreal)
-
Sherbrooke, Quebec, Canada, J1J 2G2
- Withdrawn
- Q & T Research Sherbrooke Inc.
-
Terrebonne, Quebec, Canada, J6X 4P7
- Recruiting
- Ctr de Med Metab de Lanaudiere
-
Victoriaville, Quebec, Canada, G6P 6P6
- Recruiting
- Diex Recherche Victoriaville
-
-
-
-
Beijing
-
Beijing, Beijing, China, 100050
- Recruiting
- Beijing Friendship Hospital, Capital Medical University
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese People's Liberation Army General Hospital
-
-
Chongqing
-
Chongqing, Chongqing, China, 404000
- Recruiting
- Chongqing University Three Gorges Hospital
-
-
Henan
-
Kaifeng, Henan, China, 450000
- Recruiting
- Huaihe Hospital of Henan University
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210011
- Recruiting
- The Second Affiliated Hospital of Nanjing Medical University_Nanjing
-
Suzhou, Jiangsu, China, 215002
- Recruiting
- Suzhou Municipal Hospital
-
Zhenjiang, Jiangsu, China, 212001
- Recruiting
- The Affiliated Hospital of Jiangsu University_Zhenjiang
-
-
Shandong
-
Ji'Nan, Shandong, China, 250000
- Recruiting
- Jinan Central Hospital
-
-
-
-
-
Barranquilla, Colombia, 80001
- Not yet recruiting
- Cimedical
-
Cali, Colombia, 760042
- Not yet recruiting
- Clinica Imbanco SAS
-
Monteria, Colombia, 230001
- Not yet recruiting
- IMAT - Oncomedica
-
-
Santander
-
Floridablanca, Santander, Colombia, 681004
- Not yet recruiting
- FOSCAL
-
-
-
-
-
Opatija, Croatia, 51 410
- Recruiting
- Thalassotherapia Opatija
-
Slavonski Brod, Croatia, 35 000
- Recruiting
- Opca bolnica Dr. Josip Bencevic
-
Varazdin, Croatia, 42 000
- Recruiting
- Opca bolnica Varazdin
-
-
Grad Zagreb
-
Zagreb, Grad Zagreb, Croatia, 10000
- Recruiting
- Poliklinika Solmed
-
-
Osječko - Baranjska Županija
-
Osijek, Osječko - Baranjska Županija, Croatia, 31000
- Recruiting
- Poliklinika SLAVONIJA OSIJEK
-
-
Primorsko - Goranska Županija
-
Rijeka, Primorsko - Goranska Županija, Croatia, 51 000
- Recruiting
- KBC Rijeka, Endokrinologija
-
-
-
-
-
Brno, Czechia, 602 00
- Recruiting
- University Hospital U sv. Anny
-
Broumov, Czechia, 550 01
- Recruiting
- Edumed Broumov
-
Holešov, Czechia, 76901
- Recruiting
- Diahaza s.r.o.
-
Plzeň 3, Czechia, 301 00
- Recruiting
- DIALINE s.r.o.
-
Praha 1, Czechia, 110 00
- Recruiting
- Diabet2 s.r.o.
-
Praha 4, Czechia, 140 00
- Recruiting
- MUDr. Michala Pelikanova
-
-
Czech Republic
-
Praha 4, Czech Republic, Czechia, 140 21
- Recruiting
- IKEM Centrum Diabetologie
-
-
-
-
-
Aarhus N, Denmark, 8200
- Recruiting
- Aarhus Universitetshospital, Steno Diabetes Center Aarhus
-
Herlev, Denmark, 2730
- Recruiting
- Steno Diabetes Center Copenhagen
-
Hillerød, Denmark, 3400
- Recruiting
- Hillerød Endokrinologisk amb. H0652
-
Hvidovre, Denmark, 2650
- Recruiting
- Hvidovre Hospital Endokrinologisk amb. 541
-
København, Denmark, 2400
- Recruiting
- Bispebjerg Hospital, IC-Forskning
-
Odense C, Denmark, 5000
- Not yet recruiting
- Steno Diabetes Center Odense
-
Odense C, Denmark, 5000
- Recruiting
- Steno Diabetes Center Odense
-
-
-
-
-
Jyväskylä, Finland, 40100
- Recruiting
- Terveystalo Jyväskylä
-
Seinäjoki, Finland, 60220
- Recruiting
- Seinäjoen keskussairaala
-
Tampere, Finland, 33100
- Recruiting
- Pihlajalinna Koskiklinikka
-
Tampere, Finland, 33100
- Recruiting
- Terveystalo Tampere Rautatienkatu
-
Turku, Finland, 20520
- Recruiting
- Turku University Hospital
-
-
-
-
-
Berlin, Germany, 13597
- Recruiting
- Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR
-
Daaden, Germany, 57567
- Recruiting
- Diabetologische Schwerpunktpraxis Daaden
-
Dortmund, Germany, 44137
- Recruiting
- Diabeteszentrum-Do Dres. K U. Ch. Busch GbR
-
Dresden, Germany, 01307
- Recruiting
- Medizinische Klinik III Studienzentrum für Stoffwechselerkrankungen der TU Dresden
-
Elsterwerda, Germany, 04910
- Recruiting
- Zentrum fuer klinische Studien Suedbrandenburg GmbH
-
Essen, Germany, 45136
- Recruiting
- InnoDiab Forschung GmbH
-
Gelnhausen, Germany, 63571
- Recruiting
- MVZ Diabeteszentrum Dr. Tews GmbH
-
Hamburg, Germany, 21109
- Recruiting
- Diabetes-Zentrum-Wilhelmsburg GbR
-
Hamburg, Germany, 22041
- Recruiting
- Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR
-
Lingen, Germany, 49808
- Recruiting
- Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz
-
Ludwigshafen, Germany, 67059
- Recruiting
- Die Praxis am Ludwigsplatz
-
Lübeck, Germany, 23562
- Recruiting
- Universitatsklinikum Schleswig-Holstein
-
München, Germany, 81667
- Recruiting
- Medicover Neuroendokrinologie MVZ
-
Oldenburg in Holstein, Germany, 23758
- Recruiting
- RED-Institut für medizinische Forschung und Fortbildung GmbH
-
Zwenkau, Germany, 04442
- Withdrawn
- Praxis für Innere Medizin
-
-
-
-
-
Athens, Greece, GR-15125
- Recruiting
- Iatriko Athinon (Athens Medical Canter)
-
Athens, Greece, 115 25
- Recruiting
- Iatriko Psychicou Private Clinic
-
Athens, Greece, GR-11527
- Recruiting
- "Laiko" General Hospital of Athens
-
Athens, Greece, GR-11527
- Recruiting
- General hospital of Athens 'G.Gennimatas'
-
Haidari-Athens, Greece, GR-12462
- Recruiting
- University Hospital of Athens ATTIKON
-
Larissa, Greece, GR-41110
- Recruiting
- Univ Gen Hospital Larisa, Endocrinology & Metabolic Disease
-
Thessaloniki, Greece, GR-54643
- Recruiting
- EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes
-
Thessaloniki, Greece, GR-54642
- Recruiting
- "Ippokrateio" G.H. of Thessaloniki
-
Thessaloniki, Greece, GR-54621
- Recruiting
- "AHEPA" University Hospital of Thessaloniki
-
Thessaloniki, Greece, 54636
- Recruiting
- "AHEPA" University Hospital of Thessaloniki
-
-
Thessaloniki
-
Nea Efkarpia, Thessaloniki, Greece, 56429
- Recruiting
- General Hospital Of Thessaloniki Papageorgiou
-
-
-
-
-
Budapest, Hungary, 1036
- Recruiting
- Óbudai Egészségügyi Centrum
-
Budapest, Hungary, 1106
- Recruiting
- Bajcsy-Zsilinszky Kórház
-
Budapest, Hungary, 1134
- Recruiting
- MH Egészségügyi Központ
-
Kaposvár, Hungary, 7400
- Recruiting
- Kaposi Mór Oktató Kórház
-
Nagykanizsa, Hungary, 8800
- Withdrawn
- Kanizsai Dorottya Korhaz
-
Szombathely, Hungary, H-9700
- Recruiting
- Markusovszky Egyetemi Oktatókórház
-
Zalaegerszeg, Hungary, 8900
- Recruiting
- Zala Megyei Szent Rafael Kórház
-
-
Csongrád-Csanád
-
Szeged, Csongrád-Csanád, Hungary, H-6725
- Recruiting
- Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
-
-
Hajdu-Bihar
-
Debrecen, Hajdu-Bihar, Hungary, 4032
- Recruiting
- Debreceni Egyetem Belgyógyászati Klinika
-
-
-
-
-
Ahmedabad, India, 390013
- Recruiting
- Swasthya Diabetes Care
-
Chandigarh, India, 160012
- Not yet recruiting
- Post Graduate Institute of Medical Education & Research
-
New Delhi, India, 110001
- Not yet recruiting
- Lady Hardinge Medical College
-
-
Andhra Pradesh
-
Vijaywada, Andhra Pradesh, India, 520002
- Recruiting
- Yalamanchi Hospitals and Research centres pvt ltd
-
-
Assam
-
Guwahati, Assam, India, 781032
- Not yet recruiting
- Gauhati Medical College and Hospital
-
-
Karnataka
-
Bengaluru, Karnataka, India, 560066
- Recruiting
- Lifecare Hospital and Research Centre
-
Mysuru, Karnataka, India, 570001
- Not yet recruiting
- K R Hospital
-
-
Maharashtra
-
Mumbai, Maharashtra, India, 400008
- Not yet recruiting
- BYL Nair Hospital and T N Medical College Department of endo
-
Thane, Maharashtra, India, 421004
- Recruiting
- Ashirwad Hospital and Research Centre
-
-
Rajasthan
-
Jaipur, Rajasthan, India, 302004
- Recruiting
- SMS Hospital
-
-
Tamil Nadu
-
Chennai, Tamil Nadu, India, 600086
- Recruiting
- Madras Diabetes Research Foundation
-
Coimbatore, Tamil Nadu, India, 641018
- Recruiting
- KG Hospital
-
-
Telangana
-
Hyderabad, Telangana, India, 500004
- Not yet recruiting
- Gleneagles Global Hospitals
-
Hyderabad, Telangana, India, 500072
- Recruiting
- Kumudini Devi Diabetes Research Center, Ramdevrao Hospital
-
-
West Bengal
-
Kolkata, West Bengal, India, 700054
- Recruiting
- Apollo Multispeciality Hospital, Kolkata
-
-
-
-
-
Haifa, Israel, 35152
- Recruiting
- Linn clinic - Clalit Health Services
-
Herzlia, Israel, 4630945
- Recruiting
- Clalit sick fund Herzlia
-
Holon, Israel, 58100
- Recruiting
- Diabetes Clinic Wolfson MC
-
Jerusalem, Israel, 91120
- Recruiting
- Diabetes Unit Hadassah Ein Karem MC
-
Rehovot, Israel, 76100
- Recruiting
- Kaplan MC
-
Tel Hashomer, Israel, 52621
- Recruiting
- Endrocrinolgy Clinic - Sheba Medical Center
-
-
-
-
-
Arezzo, Italy, 52100
- Recruiting
- Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato
-
Bergamo, Italy, 24127
- Recruiting
- Azienda Ospedaliera Papa Giovanni XXIII
-
Catanzaro, Italy, 88100
- Recruiting
- Azienda Ospedaliero-Universitaria Renato Dulbecco
-
Chieti Scalo, Italy, 66100
- Recruiting
- Università degli studi G. D'Annunzio Chieti Pescara - CAST
-
Milano, Italy, 20157
- Recruiting
- Azienda Ospedaliera Luigi Sacco
-
Napoli, Italy, 80131
- Recruiting
- Azienda Ospedaliera Universitaria Federico II di Napoli
-
Palermo, Italy, 90127
- Recruiting
- Dip. di Medicina Interna Policlinico Universitario Palermo
-
Palermo, Italy, 90127
- Not yet recruiting
- AOUP Giaccone Palermo
-
Roma, Italy, 00161
- Recruiting
- Azienda Ospealiero Universitaria Policlinico Umberto I
-
Rome, Italy, 00168
- Recruiting
- Policlinico A. Gemelli
-
Verona, Italy, 37126
- Not yet recruiting
- AOU Integrata di Verona - Ospedale Civile Maggiore
-
-
Fi
-
Firenze, Fi, Italy, 50134
- Recruiting
- AOU Careggi Firenze
-
-
MI
-
Milano, MI, Italy, 20132
- Recruiting
- Istituto Scientifico San Raffaele
-
-
-
-
-
Chiba-shi, Chiba, Japan, 260-0804
- Recruiting
- Akaicho Clinic
-
Ibaraki, Japan, 311-0113
- Active, not recruiting
- Naka Kinen Clinic
-
Mito-shi, Ibaraki, Japan, 311-4153
- Recruiting
- Minami Akatsuka Clinic
-
Osaka-shi, Osaka, Japan, 530-8480
- Recruiting
- Medical Research Institute KITANO HOSPITAL, Diabetes & Endocrinology
-
Tokyo, Japan, 104-0031
- Active, not recruiting
- Fukuwa Clinic
-
Tokyo, Japan, 103-0027
- Active, not recruiting
- Tokyo-Eki Center-Building Clinic
-
-
Fukushima, Japan
-
Koriyama-shi, Fukushima, Japan, Japan, 963-8851
- Recruiting
- Seino Internal Medicine Clinic
-
-
Oita, Japan
-
Oita-shi, Oita, Japan, Japan, 870 0039
- Recruiting
- Abe Diabetes Clinic_Internal Medicine
-
-
-
-
-
Daegu, Korea, Republic of, 42415
- Recruiting
- Yeungnam University Medical Center
-
Gwangju, Korea, Republic of, 501-717
- Recruiting
- Chosun university hospital
-
Seoul, Korea, Republic of, 03080
- Recruiting
- Seoul National University Hospital
-
Seoul, Korea, Republic of, 02447
- Recruiting
- Kyunghee University Medical Center
-
Seoul, Korea, Republic of, 02841
- Recruiting
- Korea University Anam Hospital
-
Seoul, Korea, Republic of, 03181
- Recruiting
- Kangbuk Samsung Hospital
-
-
Gyeonggi-do
-
Bucheon-si, Gyeonggi-do, Korea, Republic of, 14647
- Recruiting
- The catholic university of Korea, Bucheon St.Mary's Hospital
-
-
-
-
Baja California
-
Mexicali, Baja California, Mexico, 21200
- Not yet recruiting
- Centro de investigación en Artritis y Osteoporosis S.C.
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico, 44670
- Not yet recruiting
- Centro de Investigacion Clinica Endocrinologica de Jalisco
-
Guadalajara, Jalisco, Mexico, 44600
- Not yet recruiting
- InstitutoJalisciense de Investigación en Diabetes y Obesidad
-
-
Tamaulipas
-
Ciudad Madero, Tamaulipas, Mexico, 89440
- Not yet recruiting
- Centro de Estudios de Investigación Metabólicos y Cardio
-
-
-
-
-
Bydgoszcz, Poland, 85-796
- Not yet recruiting
- Centrum Medyczne Pratia Bydgoszcz
-
Lublin, Poland, 20-362
- Recruiting
- Ko-Med Nova Sp.zo.o. Lublin II
-
Pulawy, Poland, 24-100
- Not yet recruiting
- KO-MED Centra Kliniczne Sp. z o.o.
-
Staszow, Poland, 28-200
- Recruiting
- Ko-Med Nova Sp.zo.o. STASZOW
-
Warszawa, Poland, 02-507
- Not yet recruiting
- Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
-
Warszawa, Poland, 00-710
- Recruiting
- NBR Polska Tomasz Klodawski
-
Zgierz, Poland, 95-100
- Not yet recruiting
- Zgierskie Centrum Kardiologii Med-Pro Polsko-Amerykańskich Klinik Serca
-
-
Lodzkie
-
Lodz, Lodzkie, Poland, 93-513
- Recruiting
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
-
-
Lubuskie
-
Gorzow Wielkopolski, Lubuskie, Poland, 66-400
- Recruiting
- Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
-
-
Malopolskie
-
Chrzanow, Malopolskie, Poland, 32-500
- Recruiting
- Malopolskie Centrum Sercowo-Naczyniowe
-
-
Masovian
-
Żyrardów, Masovian, Poland, 96-300
- Not yet recruiting
- Prywatna Praktyka Lekarska Anna Chudoba
-
-
Mazovian Voivodeship
-
Warszawa, Mazovian Voivodeship, Poland, 02-117
- Recruiting
- Instytut Diabetologii Sp. z o.o.
-
-
Podkarpackie
-
Rzeszow, Podkarpackie, Poland, 35-055
- Recruiting
- Centrum Medyczne Medyk Sp. z o.o.
-
-
Podlaskie
-
Bialystok, Podlaskie, Poland, 15-435
- Recruiting
- NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska
-
Bialystok, Podlaskie, Poland, 15-351
- Recruiting
- Osteo Medic s.c. Artur Racewicz Jerzy Supronik
-
-
Slaskie
-
Dąbrowa-Górnicza, Slaskie, Poland, 41-300
- Recruiting
- PAKS III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
-
Tychy, Slaskie, Poland, 43-100
- Recruiting
- PAKS III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii
-
-
-
-
-
Bacau, Romania, 600154
- Recruiting
- CMI Dr. Pletea Noemi SRL
-
Brasov, Romania, 500283
- Recruiting
- Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed
-
Brasov, Romania, 500101
- Recruiting
- Mariodiab Clinic SRL
-
Bucuresti, Romania, 050913
- Recruiting
- Diabet Med SRL
-
Craiova, Romania, 200349
- Recruiting
- Urodiamed SRL
-
Galati, Romania, 800001
- Recruiting
- S.C Milena Sante SRL
-
Mangalia, Romania, 905500
- Withdrawn
- Gama Diamed Srl
-
Pascani, Romania, 705200
- Recruiting
- Bella Praxis S.R.L.
-
Reghin, Romania, 545300
- Recruiting
- Poli Cardinal Med Srl
-
-
Arges
-
Pitesti, Arges, Romania, 110283
- Withdrawn
- Cabinet Medical Individual Dr. Ramona Dragut SRL
-
-
Bucurestii
-
Bucharest, Bucurestii, Romania, 020475
- Recruiting
- Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
-
-
Cluj
-
Cluj Napoca, Cluj, Romania, 400006
- Recruiting
- Spitalul Clinic Judetean Urgenta Cluj-Napoca
-
-
Prahova
-
Ploiesti, Prahova, Romania, 100179
- Recruiting
- Diabmed Dr Popescu Alexandrina SRL
-
Ploiesti, Prahova, Romania, 100342
- Recruiting
- CMI Dr. Busegeanu Mihaela Magdalena
-
-
Salaj
-
Zalau, Salaj, Romania, 450112
- Recruiting
- Cabinet Medical de Diabet, Nutritie si Boli Metabolice-Dr. Zaharie Daniela Gabriela
-
-
-
-
-
Belgrade, Serbia, 11080
- Recruiting
- Clinical Hospital Center Bezanijska Kosa
-
Belgrade, Serbia, 11000
- Recruiting
- CHC Zvezdara, Clinical department for endocrinology
-
Belgrade, Serbia, 11000
- Recruiting
- Endocrinology, Diabetes and Metabolism Diseases Clinic
-
Belgrade, Serbia, 11000
- Not yet recruiting
- Endocrinology, Diabetes and Metabolism Diseases Clinic
-
Kragujevac, Serbia, 34000
- Recruiting
- Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr
-
Kragujevac, Serbia, 34000
- Recruiting
- Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department
-
-
Vojvodina
-
Novi Sad, Vojvodina, Serbia, 21000
- Recruiting
- Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.
-
-
-
-
-
Bardejov, Slovakia, 08501
- Recruiting
- DIADA s.r.o.
-
Kosice, Slovakia, 040 01
- Not yet recruiting
- Diabetologicka ambulancia DIOLI s.r.o.
-
Kosice, Slovakia, 040 01
- Recruiting
- DIOLI s.r.o.
-
Malacky, Slovakia, 90101
- Recruiting
- MediVet s.r.o.
-
Presov, Slovakia, 080 01
- Recruiting
- DIALIPID, s.r.o.
-
Presov, Slovakia, 080 01
- Not yet recruiting
- DIALIPID, s.r.o.
-
Prievidza, Slovakia, 971 01
- Recruiting
- MUDr. Jan Culak, s.r.o.
-
Ruzomberok, Slovakia, 034 01
- Recruiting
- DIACENTRUM, s.r.o.
-
Ruzomberok, Slovakia, 034 01
- Not yet recruiting
- DIACENTRUM, s.r.o.
-
Sabinov, Slovakia, 083 01
- Not yet recruiting
- MEDI-DIA s.r.o.
-
Sabinov, Slovakia, 083 01
- Recruiting
- MEDI-DIA s.r.o.
-
Surany, Slovakia, 942 01
- Recruiting
- DEImedi, s. r. o.
-
Surany, Slovakia, 942 01
- Not yet recruiting
- DEImedi, s. r. o.
-
Trebisov, Slovakia, 075 01
- Recruiting
- ARETEUS s.r.o.
-
Trebisov, Slovakia, 075 01
- Not yet recruiting
- ARETEUS s.r.o.
-
Ziar nad Hronom, Slovakia, 965 01
- Recruiting
- iDia s. r. o.
-
Ziar nad Hronom, Slovakia, 965 01
- Not yet recruiting
- iDia s. r. o.
-
-
-
-
-
Kocevje, Slovenia, 1330
- Recruiting
- Healthcare centre Kocevje
-
Koper, Slovenia, 6000
- Recruiting
- Healthcare Centre Koper
-
Ljubljana, Slovenia, 1000
- Withdrawn
- UKC Ljubljana, Endocrinology and Diabetes
-
Ljubljana, Slovenia, 1000
- Recruiting
- Dermatologija Bartenjev
-
Maribor, Slovenia, 2000
- Recruiting
- UKC Maribor - diabetes
-
Nova Gorica, Slovenia, 5000
- Recruiting
- Healtcare Centre Nova Gorica
-
Sempeter pri Gorici, Slovenia, 5290
- Not yet recruiting
- General Hospital Nova Gorica_Diabetes
-
Topolšica, Slovenia, 3326
- Recruiting
- Hospital Topolšica
-
-
-
-
Eastern Cape
-
Port Elizabeth, Eastern Cape, South Africa, 6001
- Recruiting
- Phoenix Pharma
-
-
Gauteng
-
Johannesburg, Gauteng, South Africa, 2001
- Recruiting
- Newtown Clinical Research
-
Johannesburg, Gauteng, South Africa, 2196
- Recruiting
- Sandton Medical Research
-
Kempton Park, Gauteng, South Africa, 1619
- Recruiting
- Clinresco Centres (Pty) Ltd
-
Pretoria, Gauteng, South Africa, 0186
- Recruiting
- Clinical Trial Systems (CTC)
-
-
Western Cape
-
Paarl, Western Cape, South Africa, 7646
- Recruiting
- Paarl Research Centre
-
-
-
-
-
Barcelona, Spain, 08035
- Recruiting
- Hospital Vall d'Hebron
-
La Coruña, Spain, 15006
- Recruiting
- Complejo Hospitalario Universitario A Coruña
-
La Roca del Vallés, Spain, 08430
- Recruiting
- ABS La Roca del Vallés
-
Móstoles, Spain, 28935
- Recruiting
- Hospital Universitario de Móstoles
-
Palma de Mallorca, Spain, 07198
- Recruiting
- Hospital Son Llatzer
-
Segovia, Spain, 40002
- Recruiting
- Hospital General de Segovia
-
Sevilla, Spain, 41010
- Recruiting
- Hospital Infanta Luisa
-
Valencia, Spain, 46026
- Recruiting
- Hospital La Fe - Endocrinología y Nutrición
-
-
-
-
-
Linköping, Sweden, 582 13
- Withdrawn
- CTC EbbePark Linköping
-
Lund, Sweden, 222 21
- Recruiting
- Clemenstorgets Hjärtmottagning
-
Lund, Sweden, 221 85
- Withdrawn
- Endokrinologkliniken
-
Malmö, Sweden, 205 02
- Recruiting
- Forskningsmottagning Internmedicin (tidigare KFE)
-
Mölndal, Sweden, 431 53
- Recruiting
- CTC GoCo Mölndal
-
Stockholm, Sweden, 171 76
- Recruiting
- Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl
-
Örebro, Sweden, 701 85
- Recruiting
- Överviktsenheten Örebro universitetssjukhus
-
-
-
-
-
Changhua City, Taiwan, 500
- Recruiting
- Changhua Christian Hospital
-
Taipei city, Taiwan, 110
- Recruiting
- Taipei Medical University Hospital
-
-
-
-
-
Adana, Turkey, 01285
- Recruiting
- Cukurova Universitesi Tip Fakultesi
-
Antalya, Turkey, 07058
- Recruiting
- Akdeniz University Tip Fakultesi Hastanesi
-
Eskisehir, Turkey, 26040
- Recruiting
- Eskisehir Osmangazi University School of Medicine
-
Istanbul, Turkey, 34371
- Recruiting
- Seyrantepe Hamidiye Etfal Eğitim ve Araştirma Hastanesi
-
Istanbul, Turkey, 34722
- Recruiting
- T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital
-
Istanbul, Turkey, 34390
- Recruiting
- Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji
-
Istanbul, Turkey, 34098
- Recruiting
- Haseki Sultangazi
-
Istanbul, Turkey, 34480
- Recruiting
- Basaksehir Cam ve Sakura Sehir Hastanesi
-
Rize, Turkey, 53020
- Recruiting
- Recep Tayyip Erdoğan Üni. Eğitim ve Araştırma Hastanesi
-
Tekirdag, Turkey, 59030
- Recruiting
- Tekirdag Namık Kemal UTF
-
-
-
-
-
Bath, United Kingdom, BA2 3HT
- Recruiting
- Oldfield Surgery
-
Blackburn, United Kingdom, BB2 1AX
- Recruiting
- Oakenhurst Surgery
-
Dundee, United Kingdom, DD1 9SY
- Recruiting
- Ninewells Hospital
-
Foresterhill, United Kingdom, AB25 2ZP
- Recruiting
- Aberdeen Royal Infirmary
-
Liverpool, United Kingdom, L9 7AL
- Recruiting
- University Hospital Aintree
-
Norwich, United Kingdom, NR4 7UY
- Recruiting
- Norfolk and Norwich University Hospital Trust
-
Pickering, United Kingdom, YO18 8BL
- Recruiting
- Pickering Medical Practice
-
Southampton, United Kingdom, SO30 3JB
- Recruiting
- Moorgreen Hospital
-
Swansea, United Kingdom, SA2 8PP
- Recruiting
- Joint Clinical Research Facility - Swansea
-
Truro, United Kingdom, TR1 3LJ
- Recruiting
- Royal Cornwall Hospital (Treliske)
-
-
Hertfordshire
-
Stevenage, Hertfordshire, United Kingdom, SG1 4AB
- Recruiting
- Lister Hospital
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35211
- Recruiting
- Synexus Clin Res-Birmingham
-
Birmingham, Alabama, United States, 35294
- Recruiting
- Univ of Alabama_Birmingham
-
Pelham, Alabama, United States, 35124
- Recruiting
- Cahaba Research
-
-
Arizona
-
Phoenix, Arizona, United States, 85006
- Recruiting
- Velocity Clinical Research-Phoenix
-
Phoenix, Arizona, United States, 85020
- Recruiting
- Synexus Cln Rsrch /Cnt Phoenix Med C
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Recruiting
- Arkansas Clinical Research
-
-
California
-
Banning, California, United States, 92220
- Recruiting
- Velocity Clinical Res-Banning
-
Chula Vista, California, United States, 91911
- Recruiting
- Velocity Clin Res-Chula Vista
-
Concord, California, United States, 94520
- Recruiting
- John Muir Physician Network
-
Escondido, California, United States, 92025
- Recruiting
- Headlands Research California, LLC
-
Gardena, California, United States, 90247
- Recruiting
- Velocity Clin Res Gardena
-
La Mesa, California, United States, 91942
- Recruiting
- Velocity Clin Res San Diego
-
La Mesa, California, United States, 91942
- Not yet recruiting
- Velocity Clin Res San Diego
-
Loma Linda, California, United States, 92354
- Recruiting
- Loma Linda Univ Hlth Cr Endo
-
Mission Hills, California, United States, 91345
- Recruiting
- Facey Medical Foundation
-
Palm Springs, California, United States, 92262
- Recruiting
- Desert Oasis Hlthcr Med Group
-
Panorama City, California, United States, 91402
- Recruiting
- Velocity Clin Res - Panorama
-
San Diego, California, United States, 92111
- Recruiting
- Linda Vista Health Care Ctr
-
Santa Ana, California, United States, 92704
- Recruiting
- Velocity Clin Res Santa Ana
-
Toluca Lake, California, United States, 91602
- Recruiting
- Premier Medical Center, Inc.
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80906
- Recruiting
- Optumcare Colorado Springs
-
-
Florida
-
Jacksonville, Florida, United States, 32204
- Recruiting
- Northeast Research Institute
-
Miami, Florida, United States, 33165
- Recruiting
- New Horizon Research Center
-
Miami, Florida, United States, 33155
- Recruiting
- Bioclinical Research Alliance
-
Miami, Florida, United States, 33144
- Recruiting
- Clinical Trial Services Corp
-
Miramar, Florida, United States, 33027
- Recruiting
- South Broward Research LLC
-
Ocoee, Florida, United States, 34761
- Recruiting
- West Orange Endocrinology
-
Orange City, Florida, United States, 32763
- Recruiting
- Optimal Research Sites
-
Orlando, Florida, United States, 32806
- Withdrawn
- Synexus Clin Res - Orlando
-
Orlando, Florida, United States, 32804
- Recruiting
- AdventHealth Diab Inst
-
Oviedo, Florida, United States, 32765
- Withdrawn
- Oviedo Medical Research, LLC
-
-
Georgia
-
Conyers, Georgia, United States, 30094
- Recruiting
- Hope Clin Res & Wellness
-
Macon, Georgia, United States, 31210
- Recruiting
- East Coast Institute for Res
-
Marietta, Georgia, United States, 30067
- Recruiting
- Urban Family Practice Assoc
-
Roswell, Georgia, United States, 30076
- Not yet recruiting
- Endocrine Research Solutions, Inc.
-
Roswell, Georgia, United States, 30076
- Recruiting
- Endocrine Research Solutions
-
-
Hawaii
-
Honolulu, Hawaii, United States, 96813
- Withdrawn
- Pacific Diabetes & Endo Ctr
-
-
Idaho
-
Boise, Idaho, United States, 83702
- Recruiting
- St. Luke's Health System
-
Meridian, Idaho, United States, 83646
- Recruiting
- Solaris Clinical Research
-
-
Illinois
-
Chicago, Illinois, United States, 60607
- Recruiting
- Cedar-Crosse Research Center
-
Gurnee, Illinois, United States, 60031
- Recruiting
- Clinical Invest Special_Gurnee
-
Skokie, Illinois, United States, 60077
- Recruiting
- NorthShore Univ Hlth Sys
-
Skokie, Illinois, United States, 60077
- Recruiting
- Evanston Premier Hlthcr Res
-
-
Iowa
-
West Des Moines, Iowa, United States, 50265
- Recruiting
- Iowa Diabetes & Endo Res Ctr
-
-
Kansas
-
Newton, Kansas, United States, 67114
- Recruiting
- Alliance for Multispec Res
-
Topeka, Kansas, United States, 66606
- Recruiting
- Cotton-O'Neil Diab & Endo Ctr
-
-
Louisiana
-
Lafayette, Louisiana, United States, 70508
- Recruiting
- Velocity Clin Res Lafayette
-
-
Massachusetts
-
New Bedford, Massachusetts, United States, 02740
- Recruiting
- BTC of New Bedford, LLC
-
-
Mississippi
-
Gulfport, Mississippi, United States, 39503
- Recruiting
- Velocity Clin Res Gulfport
-
-
Missouri
-
Chesterfield, Missouri, United States, 63017
- Recruiting
- Diabetes & Endo Specialists Inc
-
-
New Jersey
-
Trenton, New Jersey, United States, 08611
- Recruiting
- Premier Research Inc.
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87107
- Recruiting
- Velocity Clin Res Albuquerque
-
-
New York
-
Albany, New York, United States, 12203
- Recruiting
- Albany Medical College - Endo
-
East Syracuse, New York, United States, 13057
- Recruiting
- Velocity Clin Res Syracuse
-
West Seneca, New York, United States, 14224
- Recruiting
- Southgate Medical Group, LLP
-
Westfield, New York, United States, 14787
- Recruiting
- Great Lakes Medical Research
-
-
North Carolina
-
Chapel Hill, North Carolina, United States, 27514
- Recruiting
- University of North Carolina
-
Greensboro, North Carolina, United States, 27408
- Recruiting
- PharmQuest Life Sciences LLC
-
Morehead City, North Carolina, United States, 28557
- Recruiting
- Carteret Medical Group
-
Statesville, North Carolina, United States, 28625
- Recruiting
- Piedmont Healthcare/Research
-
Wilmington, North Carolina, United States, 28401
- Recruiting
- Accellacare
-
-
Ohio
-
Akron, Ohio, United States, 44311
- Recruiting
- Radiant Research Inc. - Akron
-
Dublin, Ohio, United States, 43016
- Recruiting
- Aventiv Research
-
-
Oklahoma
-
Norman, Oklahoma, United States, 73069
- Recruiting
- Alliance for Multispec Res
-
-
Rhode Island
-
Cumberland, Rhode Island, United States, 02864
- Recruiting
- Clinical Res Collaborative
-
East Greenwich, Rhode Island, United States, 02818
- Recruiting
- Velocity Clin Res Providence
-
-
South Carolina
-
Anderson, South Carolina, United States, 29621
- Recruiting
- Synexus Clin Res US-Anderson
-
Anderson, South Carolina, United States, 29621
- Recruiting
- Velocity Clinical Res-Anderson
-
Anderson, South Carolina, United States, 29621
- Recruiting
- AnMed Health IMA
-
Gaffney, South Carolina, United States, 29340
- Recruiting
- Velocity Clin Res Gaffney
-
Simpsonville, South Carolina, United States, 29681-1538
- Recruiting
- Hillcrest Clinical Research
-
Spartanburg, South Carolina, United States, 29303
- Recruiting
- Spartanburg Medical Research
-
Spartanburg, South Carolina, United States, 29303
- Recruiting
- Velocity Clin Res Spartanburg
-
-
Tennessee
-
Bristol, Tennessee, United States, 37620-7352
- Recruiting
- Holston Medical Group Pc
-
Kingsport, Tennessee, United States, 37660
- Recruiting
- Holston Medical Group
-
Nashville, Tennessee, United States, 37203
- Recruiting
- Clinical Research Associates
-
-
Texas
-
Arlington, Texas, United States, 76012-4637
- Recruiting
- Arlington Family Res. Ctr Inc
-
Austin, Texas, United States, 78759
- Recruiting
- Velocity Clin Res Austin
-
Bellaire, Texas, United States, 77401
- Recruiting
- UT Health University of Texas
-
Dallas, Texas, United States, 75251
- Recruiting
- Cedar Health Research
-
Dallas, Texas, United States, 75231
- Recruiting
- North Texas Endocrine Center
-
Dallas, Texas, United States, 75230
- Recruiting
- Velocity Clinical Res-Dallas
-
Dallas, Texas, United States, 75234
- Recruiting
- Synexus Clin Res Dallas
-
Houston, Texas, United States, 77061
- Recruiting
- Synergy Groups Medical
-
Houston, Texas, United States, 77040
- Recruiting
- Juno Research, LLC_Houston
-
Houston, Texas, United States, 77079
- Recruiting
- PlanIt Research, PLLC
-
Katy, Texas, United States, 77450
- Recruiting
- Medical Colleagues-Texas LLP
-
Kerrville, Texas, United States, 78028
- Recruiting
- Sante Clinical Research
-
Missouri City, Texas, United States, 77459
- Recruiting
- Discovery MMS Services, INC
-
San Antonio, Texas, United States, 78233
- Recruiting
- NE Clin Res of San Antonio
-
San Antonio, Texas, United States, 78229
- Recruiting
- AES San Antonio
-
San Antonio, Texas, United States, 78229
- Recruiting
- Univ Of Texas Hlth Science Cntr
-
Shavano Park, Texas, United States, 78231
- Recruiting
- Consano Clinical Research, LLC
-
Tomball, Texas, United States, 77375
- Recruiting
- DM Clin Rsrch/Fam Diag Clinic
-
-
Utah
-
Sandy, Utah, United States, 84093
- Recruiting
- Diabetes & Endo Treatment Spec
-
West Jordan, Utah, United States, 84088
- Recruiting
- Velocity Clin Res-Salt Lk City
-
-
Virginia
-
Newport News, Virginia, United States, 23606
- Recruiting
- TPMG Clinical Research
-
-
Washington
-
Renton, Washington, United States, 98057
- Recruiting
- Rainier Clin Res Ctr Inc
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54303
- Recruiting
- 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
No
Description
Inclusion Criteria:
- Male or female.
- 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 a fundus 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
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CagriSema 2.4 mg/2.4 mg
Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.
|
Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of cagrilintide is reached.
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.
|
|
Experimental: CagriSema 1.0 mg/1.0 mg
Participants will receive once-weekly s.c injections of 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.
|
Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of cagrilintide is reached.
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.
|
|
Active Comparator: Semaglutide 2.4 mg
Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 68 weeks.
|
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.
|
|
Active Comparator: Semaglutide 1.0 mg
Participants will receive once-weekly s.c injection of 1.0 mg semaglutide for 68 weeks.
|
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.
|
|
Active Comparator: Cagrilintide 2.4 mg
Participants will receive once-weekly s.c injection of 2.4 mg cagrilintide for 68 weeks.
|
Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of cagrilintide is reached.
|
|
Placebo Comparator: Placebo 2.4 mg/2.4 mg
Participants will receive once-weekly s.c injection of placebo matched to 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.
|
Participants will receive placebo matched to cagrilintide subcutaneously.
Participants will receive placebo matched to semaglutide subcutaneously.
|
|
Placebo Comparator: Placebo 1.0 mg/1.0 mg
Participants will receive once-weekly s.c injection of placebo matched to 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.
|
Participants will receive placebo matched to cagrilintide subcutaneously.
Participants will receive placebo matched to semaglutide subcutaneously.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): 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)
|
|
CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg: 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 2.4 mg/2.4 mg versus cagrilintide 2.4 mg: 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 2.4 mg/2.4 mg versus semaglutide 1.0 mg: 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 2.4 mg/2.4 mg versus semaglutide 1.0 mg: 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 2.4 mg 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 2.4 mg 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time in Tight Target Range (TITR) 3.9-7.8 millimoles per litre (mmol/L) (70-140 milligrams per decilitre [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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): 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 (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: 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 (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: 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 (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: 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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
November 26, 2025
Study Completion (Estimated)
January 14, 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)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
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
No
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.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Diabetes Foundation, IndiaNational Diabetes Obesity and Cholesterol FoundationRecruitingType 2 Diabetes Mellitus With ComplicationIndia
Clinical Trials on Cagrilintide
-
Novo Nordisk A/SCompleted
-
Novo Nordisk A/SCompletedDiabetes Mellitus, Type 2United States
-
Novo Nordisk A/SRecruitingObesity | OverweightGermany
-
Novo Nordisk A/SActive, not recruitingObesity | Overweight | Type 2 Diabetes MellitusUnited States, India, Poland, Malaysia, United Kingdom, Japan, Thailand, Germany, Austria, Canada, Hungary, Ireland, Puerto Rico
-
Novo Nordisk A/SActive, not recruitingObesityFinland, Spain, Taiwan, Korea, Republic of, United States, Netherlands, India, Japan, United Kingdom, Germany, Poland, Serbia, Denmark, Canada, Bulgaria, Australia, South Africa, Italy, Mexico, Belgium, Turkey, France, Argentina
-
Novo Nordisk A/SRecruiting
-
Novo Nordisk A/SRecruiting
-
Novo Nordisk A/SCompleted
-
Novo Nordisk A/SRecruitingType 2 DiabetesUnited States, Serbia, Italy, Poland, China, Hungary, Saudi Arabia
-
Novo Nordisk A/SRecruitingObesity | Type 2 Diabetes | Chronic Kidney DiseaseUnited States, Spain, Thailand, India, France, Poland, Canada, Japan, Greece, Hungary, Argentina, Brazil, Slovakia