A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
August 27, 2026 updated by: Novo Nordisk A/S
A Clinical Study to Compare Efficacy and Safety of Two Different Doses of CagriSema and Semaglutide in Participants With Obesity With or Without Type 2 Diabetes
This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight.
The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants.
Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance.
CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe.
The study will last for about 83 weeks
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
2500
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
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Buenos Aires, Argentina, C1425AGC
- Recruiting
- Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
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Buenos Aires, Argentina, C1119ACU
- Recruiting
- Kynet Recoleta
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Buenos Aires, Argentina, C1015
- Recruiting
- OMI- Organización Médica de Investigación
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Buenos Aires, Argentina, C1419
- Recruiting
- Hospital Sirio Libanes
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CABA, Argentina, C1060ABA
- Not yet recruiting
- CEDIC Centro de Investigación Clínica
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CABA, Argentina, C1061AAS.
- Recruiting
- CIPREC Arenales
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CABA, Argentina, C1120AAC
- Recruiting
- Centro Médico Viamonte SRL
-
Ciudad de Buenos Aires, Argentina, C1204AAD
- Recruiting
- Instituto Centenario
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Santa Fe, Argentina, S3000FSO
- Recruiting
- CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
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Santiago del Estero, Argentina, G4200
- Recruiting
- Sanatorio Norte
-
-
Buenos Aires
-
CABA, Buenos Aires, Argentina, C1440CFD
- Recruiting
- CEMEDIC
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Capital Federal, Buenos Aires, Argentina, C1056ABI
- Recruiting
- Centro de Investigaciones Metabólicas
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1424CIQ
- Recruiting
- CICEMO- Consultorio (Av Directorio)
-
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1427
- Recruiting
- Centro Médico Arsema
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Tucumán Province
-
San Miguel de Tucumán, Tucumán Province, Argentina, T4000DPX
- Recruiting
- Centro de Investigación C.I.C.E 9 de Julio - Sanatorio 9 de Julio
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New South Wales
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Campbelltown, New South Wales, Australia, 2560
- Recruiting
- Sydney Clinical Trials
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Gosford, New South Wales, Australia, 2250
- Recruiting
- Gosford Renal Research
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Liverpool, New South Wales, Australia, 2170
- Recruiting
- Sydney Cardiometabolic Centre
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Merewether, New South Wales, Australia, 2291
- Recruiting
- Hunter Diabetes Centre
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Queensland
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Birtinya, Queensland, Australia, 4575
- Recruiting
- University of Sunshine Coast - Vitality Village
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South Brisbane, Queensland, Australia, 4101
- Recruiting
- University of Sunshine Coast - South Brisbane
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Victoria
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Camberwell, Victoria, Australia, 3124
- Recruiting
- Emeritus Research Melbourne
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Graz, Austria, 8036
- Recruiting
- Medical University of Graz
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Mattersburg, Austria, 7210
- Recruiting
- Ordination Winhofer-Stöckl
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Saint Stefan, Austria, 8511
- Recruiting
- Fließer-Görzer [Ordination]
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Vienna, Austria, 1090
- Recruiting
- Universitätsklinikum AKH Wien
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Vienna, Austria, 1030
- Recruiting
- Klinik Landstraße
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Vienna, Austria, 1130
- Recruiting
- Klinik Hietzing 3. Med. Abt.
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Vienna, Austria, 1180
- Recruiting
- Itariu [Ordination]
-
Vienna, Austria, 1120
- Recruiting
- Ordination Dr. Günter Sokol
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Alken, Belgium, 3570
- Recruiting
- Anima Research Center
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Brussels, Belgium, 1200
- Not yet recruiting
- Cliniques Universitaires Saint-Luc
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Kluisbergen, Belgium, 9690
- Recruiting
- KORMONT
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La Louvière, Belgium, 7100
- Recruiting
- CHU Tivoli
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Mechelen, Belgium, 2800
- Recruiting
- Meclinas
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Roeselare, Belgium, 8800
- Recruiting
- AZ Delta - Roeselare
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Zwalm, Belgium, 9630
- Recruiting
- KORMONT
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Burgas, Bulgaria, 8000
- Recruiting
- MC For Life EOOD
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Kazanlak, Bulgaria, 6100
- Recruiting
- MC Kazanlak EOOD
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Kyustendil, Bulgaria, 2500
- Recruiting
- Medical center Medi City 21 OOD
-
Pleven, Bulgaria, 5800
- Recruiting
- OCSOMCE - Dr. Albena Dinkova EOOD
-
Plovdiv, Bulgaria, 4000
- Recruiting
- AIPSMCEMDID - Dr. Georgi Levterov EOOD
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Plovdiv, Bulgaria, 4002
- Recruiting
- DCC Sveti Georgi EOOD
-
Sofia, Bulgaria, 1618
- Recruiting
- MC Diamedical - 2013 OOD, Sofia
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Sofia, Bulgaria, 1463
- Recruiting
- Hipocrat 9 - Dr. Rumyana Boykova - Draganova - AISPEMD EOOD
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Sofia, Bulgaria, 1618
- Recruiting
- DCC XX - Sofia EOOD, Endocrinology
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Sofia, Bulgaria, 1618
- Recruiting
- Medical Centre Medical Arts Medico-dental centre
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Sofia, Bulgaria, 1712
- Recruiting
- DCC XXV Sofia EOOD, Endocrinology Consulting room
-
Stara Zagora, Bulgaria, 6003
- Recruiting
- UMHAT Prof. Dr. Stoyan Kirkovich AD
-
Varna, Bulgaria, 9010
- Recruiting
- AIPSMC Dr. Evelina Zlatanova EOOD
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Veliko Tarnovo, Bulgaria, 5005
- Recruiting
- MC Nevromedics EOOD, Internal Diseases
-
-
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Québec, Canada, G2J 0C4
- Recruiting
- Alpha Recherche Clinique - Lebourgneuf
-
Québec, Canada, G1V 4T3
- Recruiting
- Diex Recherche Quebec
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Alberta
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Calgary, Alberta, Canada, T2V 4J2
- Recruiting
- C-Health Partners
-
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British Columbia
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Kelowna, British Columbia, Canada, V1Y 5A8
- Recruiting
- Kelowna Health and Memory Centre Ltd.
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Kelowna, British Columbia, Canada, V1Y4N7
- Recruiting
- Medical Arts Health Research Group_Kelowna
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Surrey, British Columbia, Canada, V3Z 2N6
- Recruiting
- Ocean West Research Clinic
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Surrey, British Columbia, Canada, V4A 0C1
- Recruiting
- Hilltop Medical Clinic
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Victoria, British Columbia, Canada, V8V 4A1
- Recruiting
- Dr. M.B. Jones Inc
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 1A7
- Recruiting
- G.A. Research Associates Ltd.
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3H1V7
- Recruiting
- Nova Scotia Hlth Halifax
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Sydney, Nova Scotia, Canada, B1M 0A1
- Recruiting
- Care Access Cape Breton
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Ontario
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Brampton, Ontario, Canada, L6S 0C6
- Recruiting
- Centricity Research Brampton Endocrinology
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Guelph, Ontario, Canada, N1G 0B4
- Not yet recruiting
- Apex Trials
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Hamilton, Ontario, Canada, L8L 5G4
- Recruiting
- Premier Clinical Trial Research Network (PCTRN)
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Hamilton, Ontario, Canada, L8L 5G4
- Recruiting
- Hamilton Medical Research Group
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Hamilton, Ontario, Canada, L8L 5G8
- Recruiting
- Wharton Medical Clinic Clinical Trials (Hamilton)
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London, Ontario, Canada, N5W 6A2
- Recruiting
- Milestone Research
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Sarnia, Ontario, Canada, N7T 4X3
- Recruiting
- Bluewater Clin Res Group Inc
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Toronto, Ontario, Canada, M6G 1M2
- Recruiting
- Diabetes Heart Research Centre
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Quebec
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Montreal, Quebec, Canada, H4N 2W2
- Recruiting
- Centre Medical Acadie
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Pointe-Claire, Quebec, Canada, H9R 4S3
- Recruiting
- Centricity Res Pointe-Claire
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Brno, Czechia, 656 91
- Recruiting
- Fakultni Nemocnice u sv. Anny v Brne
-
Dolní Břežany, Czechia, 252 41
- Recruiting
- Centrum zdraví Dolní Břežany, a.s.
-
Liberec, Czechia, 460 01
- Recruiting
- KARDIOLOGIE - LIBEREC s.r.o.
-
Náchod, Czechia, 54701
- Recruiting
- Interní a diabetologická ordinace s.r.o.
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Plzeň 3, Czechia, 301 00
- Recruiting
- DIALINE s.r.o.
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Prague, Czechia, 149 00
- Recruiting
- Milan Kvapil s.r.o.
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Prague, Czechia, 150 00
- Recruiting
- EUC Klinika Praha a.s.
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Prague, Czechia, 160 00
- Recruiting
- Fledip s.r.o.
-
Prague, Czechia, 10400
- Recruiting
- ENDOTRIAL s.r.o.
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Bois-Guillaume, France, 76230
- Not yet recruiting
- CHU ROUEN_HOPITAL DE BOIS GUILLAUME_Service de Nutrition
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Colmar, France, 68024
- Not yet recruiting
- CENTRE HOSPITALIER DE COLMAR_Endocrinologie/Diabetologie/Centre Nutritionnel
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Le Coudray, France, 28630
- Active, not recruiting
- LES HOPITAUX DE CHARTRES_HOPITAL LOUIS PASTEUR_Service d'endocrinologie
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Paris, France, 75015
- Not yet recruiting
- HOPITAL EUROPEEN GEORGES POMPIDOU_Service de nutrition et diabétologie
-
Paris, France, 75013
- Active, not recruiting
- APHP - LA PITIE SALPETRIERE _ Service de Nutrition
-
Pessac, France, 33600
- Not yet recruiting
- CHU DE BORDEAUX-HOPITAL HAUT LEVEQUE_Service d'Endocrinologie, Diabétologie et Maladies Métaboliques
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Pierre-Bénite, France, 69310
- Not yet recruiting
- HCL-HOPITAL LYON SUD_Service d'Endocrinologie-Diabète-Nutrition
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Saint-Herblain, France, 44800
- Completed
- CHU NANTES - HOPITAL NORD LAENNEC_Service d'Endocrinologie-Diabétologie-Nutrition
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Vénissieux, France, 69200
- Active, not recruiting
- CENTRE DE RECHERCHE CLINIQUE PORTES DU SUD_Service d'Endocrinologie-Diabétologie-Maladies Métaboliques
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Alexandroupoli, Greece, 68100
- Not yet recruiting
- University General Hospital Of Alexandroupoli - First Department of Internal Medicine
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Athens, Greece, 115 27
- Recruiting
- Laiko General Hospital Of Athens - 1st department of Internal Medicine
-
Athens, Greece, 11528
- Recruiting
- General Hospital Of Athens Alexandra - Clinical Therapeutics
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Athens, Greece, 10676
- Recruiting
- Evangelismos S.A. - Endocrinology department
-
Athens, Greece, 11525
- Recruiting
- Athens Medical Center S.A. (Iatriko Psychikou) - Department of Internal Medicine & Metabolic Diseases
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Lamia, Greece, 35100
- Not yet recruiting
- General Hospital Of Lamia - Internal Medicine Clinic
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Marousi, Greece, 15125
- Recruiting
- Athens Medical Center S.A. (Iatriko Athinon) - Diabetes and Obesity Unit
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Palaió Fáliro, Greece, 17562
- Recruiting
- Athens Medical Center S.A. (Iatriko P. Falirou) - Diabetes and Clinical Research Center
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Peristeri, Greece, 121 31
- Recruiting
- Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department
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Thessaloniki, Greece, 54635
- Recruiting
- NextHealth S.A. - Department of Endocrinology, Metabolism & Diabetes
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Thessaloniki, Greece, 57001
- Recruiting
- Thermi Clinic S.A. - Diabetes and Internal Medicine Department
-
Thessaloniki, Greece, 546 39
- Not yet recruiting
- Athens Medical Center S.A., European Interbalkan Medical Center - Department of Internal Medicine
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Thessaloniki, Greece, 54635
- Recruiting
- General Hospital Of Thessaloniki G Gennimatas - Internal Medicine Clinic
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Baja, Hungary, 6500
- Recruiting
- EURÉKA-CENTER Orvosi és Szolgáltató Betéti Társaság
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Biatorbágy, Hungary, 2051
- Recruiting
- Biatros Kft.
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Budapest, Hungary, 1083
- Recruiting
- Semmelweis Egyetem
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Budapest, Hungary, H-1141
- Recruiting
- Cardiogeneral Kft.
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Békéscsaba, Hungary, 5600
- Recruiting
- Bekes Varmegyei Kozponti Korhaz
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Békéscsaba, Hungary, 5600
- Recruiting
- Trial Pharma Kft.
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Szolnok, Hungary, 5000
- Recruiting
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet
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Székesfehérvár, Hungary, 8000
- Not yet recruiting
- Mentaház Kft.
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Bekes County
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Békéscsaba, Bekes County, Hungary, 5600
- Recruiting
- Dr. Lakatos Ferenc Kardiológus ,Belgyógyász Magán szakrendelés
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Bács-Kiskun county
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Baja, Bács-Kiskun county, Hungary, 6500
- Recruiting
- Lausmed Kft.
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Csongrád-Csanád
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Szeged, Csongrád-Csanád, Hungary, 6725
- Recruiting
- Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ
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Pest County
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Budapest, Pest County, Hungary, 1036
- Recruiting
- Óbudai Egészségügyi Centrum
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Budapest, Pest County, Hungary, 1213
- Not yet recruiting
- Szatmári-Med Kft.
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Szabolcs-Szatmár-Bereg
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Nyíregyháza, Szabolcs-Szatmár-Bereg, Hungary, 4400
- Recruiting
- Medifarma-98 Kft.
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Catanzaro, Italy, 88100
- Recruiting
- Azienda Ospedaliero-Universitaria Renato Dulbecco
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Emilia-Romagna
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Bologna, Emilia-Romagna, Italy, 40138
- Not yet recruiting
- AOU IRCCS Policlinico di Sant'Orsola Malpighi - UOC Endocrinologia e Prevenzione e Cura del Diabete
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Liguria
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Genoa, Liguria, Italy, 16132
- Not yet recruiting
- IRCCS Ospedale Policlinico San Martino - U.O.D. Dietetica e Nutrizione Clinica
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Lombardy
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Brescia, Lombardy, Italy, 25123
- Not yet recruiting
- Spedali Civili Brescia - SSD Endocrinologia
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Milan, Lombardy, Italy, 20132
- Recruiting
- Ospedale San Raffaele S.r.l. - Unità di Cardio-metabolismo e Trials Clinici
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Pg
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Perugia, Pg, Italy, 06129
- Not yet recruiting
- Azienda Ospedaliera di Perugia;Ospedale S. Maria della Misericordia
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Sicily
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Messina, Sicily, Italy, 98124
- Recruiting
- D.A.I. Oncologico - U.O.C. di Chirurgia Generale ad indirizzo Oncologico
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The Marches
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Ancorna, The Marches, Italy, 60127
- Recruiting
- INRCA Ancona - UOC Clinica Medica e Geriatrica
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Tuscany
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Pisa, Tuscany, Italy, 56126
- Not yet recruiting
- Azienda Ospedaliero Universitaria Pisana
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Arnhem, Netherlands, 6815 AD
- Recruiting
- Rijnstate Ziekenhuis
-
Eindhoven, Netherlands, 5623 EJ
- Not yet recruiting
- Catharina Zkh Eindhoven - Interne geneeskunde
-
Hoofddorp, Netherlands, 2134 TM
- Not yet recruiting
- Spaarne Gasthuis Hoofddorp - Interne
-
Hoogeveen, Netherlands, 7909 AA
- Recruiting
- Bethesda Diabetes Research Center
-
Rotterdam, Netherlands, 3083 AN
- Recruiting
- Ikazia Ziekenhuis
-
The Hague, Netherlands, 2565 KV
- Recruiting
- Medisch Centrum Thomsonplein
-
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Limburg
-
Born, Limburg, Netherlands, 6121 XK
- Recruiting
- PreCare Trial & Recruitment
-
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North Brabant
-
's-Hertogenbosch, North Brabant, Netherlands, 5223 LA
- Recruiting
- Progress Clinical Research Den Bosch
-
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Bialystok, Poland, 15-276
- Recruiting
- Uniwersytecki Szpital Kliniczny w Bialymstoku
-
Bialystok, Poland, 15-281
- Not yet recruiting
- Gabinet Leczenia Otylosci i Chorob Dietozaleznych
-
Bialystok, Poland, 15-481
- Recruiting
- Kresmed Sp. z o. o.
-
Bialystok, Poland, 15-797
- Recruiting
- Renew Clinic Sp. z o.o.
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Bygdoszcz, Poland, 85-796
- Recruiting
- Gierach-Med
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Dębica, Poland, 39-200
- Recruiting
- ETG Lublin Sp. z o.o.
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Katowice, Poland, 40-648
- Recruiting
- Pro Familia Altera Sp. z o.o.
-
Katowice, Poland, 40-748
- Recruiting
- Vita Longa Sp. z o. o.
-
Krakow, Poland, 30-149
- Recruiting
- Małopolskie Centrum Kliniczne
-
Poznan, Poland, 61-251
- Recruiting
- Maciej Wiza Gaja Poradnie Lekarskie
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Rzeszów, Poland, 35-055
- Recruiting
- Centrum Medyczne Medyk Sp.zo.o. Sp.k.
-
Warsaw, Poland, 02-679
- Recruiting
- Medon Clinical Research Sp. z o.o.
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Warsaw, Poland, 00-124
- Recruiting
- Gyncentrum Sp. z o. o.
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Wroclaw, Poland, 52-416
- Not yet recruiting
- Centrum Medyczne Oporow
-
Wroclaw, Poland, 51-149
- Not yet recruiting
- Wojewodzki Szpital Specjalistyczny im. J. Gromkowskiego
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Almada, Portugal, 2805-267
- Recruiting
- ULS Almada-Seixal E.P.E. - HGO_Serviço de Endocrinologia
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Caldas da Rainha, Portugal, 2500-176
- Recruiting
- ULS Do Oeste E.P.E. - Unidade Caldas da Rainha_CAMI - Unidade de Diabetes
-
Figueira da Foz Municipality, Portugal, 3094-001
- Recruiting
- ULS Do Baixo Mondego, E.P.E. - HDFF_Serviço Cardiologia
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Lisbon, Portugal, 1500-650
- Recruiting
- Hospital da Luz Lisboa, S.A._Serviço de Medicina Interna
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Senhora Da Hora, Matosinhos, Portugal, 4464-513
- Recruiting
- ULS De Matosinhos, E.P.E - HPH_Serviço de Endocrinologia
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Vila Nova de Gaia, Portugal, 4400-346
- Recruiting
- Hospital da Luz Arrábida, S.A_Serviço de Endocrinologia
-
Vila do Conde, Portugal, 4480-565
- Recruiting
- Hospital Trofa Saude Senhor do Bonfim S.A_Unidade de Ensaios Clínicos
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Riachos
-
Torres Novas, Riachos, Portugal, 2350-325
- Recruiting
- Ucardio Centro Clinico Unidade Cardiovascular
-
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Brasov, Romania, 500101
- Not yet recruiting
- Mariodiab Clinic SRL
-
Bucharest, Romania, 010507
- Recruiting
- SC Nicodiab SRL
-
Buzău, Romania, 120133
- Recruiting
- Mat Cord Biomedica S.R.L.
-
Oradea, Romania, 410469
- Recruiting
- Spitalul Clinic Judetean de Urgenta Bihor
-
Piteşti, Romania, 110424
- Recruiting
- Sc Sal Med Srl
-
Timișoara, Romania, 300723
- Recruiting
- Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
-
Timișoara, Romania, 300288
- Recruiting
- Cabinet Medical Dr Geru SRL
-
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Bihor County
-
Oradea, Bihor County, Romania, 410159
- Recruiting
- Grandmed SRL
-
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Dolj
-
Craiova, Dolj, Romania, 200515
- Recruiting
- S.C. Top Diabet Srl
-
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Maramureş
-
Baia Mare, Maramureş, Romania, 430222
- Recruiting
- CMI Dr Pop Lavinia
-
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Mureș County
-
Târgu Mureş, Mureș County, Romania, 540142
- Recruiting
- Sc Mediab Srl
-
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-
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Bojnice, Slovakia, 97201
- Active, not recruiting
- DIA - CLARUS s.r.o.
-
Bratislava, Slovakia, 851 01
- Active, not recruiting
- MEDISPEKTRUM s.r.o.
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Bratislava, Slovakia, 84108
- Active, not recruiting
- KARDIO-SANUS, spol. s r.o.
-
Bytča, Slovakia, 014 01
- Active, not recruiting
- Diab - Int, s.r.o.
-
Košice, Slovakia, 040 01
- Active, not recruiting
- Human-Care, s.r.o.
-
Košice, Slovakia, 04013
- Active, not recruiting
- Endomed, s.r.o.
-
Martin, Slovakia, 036 01
- Active, not recruiting
- DIAMARTIN, s. r. o.
-
Spišská Nová Ves, Slovakia, 05201
- Active, not recruiting
- LUDIA, s. r. o.
-
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-
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Eastern Cape
-
Port Elizabeth, Eastern Cape, South Africa, 6001
- Recruiting
- Phoenix Pharma
-
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Free State
-
Bloemfontein, Free State, South Africa, 9301
- Recruiting
- Iatros International
-
Bloemfontein, Free State, South Africa, 9301
- Recruiting
- Medi-Clinic Bloemfontein
-
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Gauteng
-
Johannesburg, Gauteng, South Africa, 1818
- Recruiting
- Soweto Clinical Trial Centre
-
Johannesburg, Gauteng, South Africa, 1827
- Recruiting
- Hemant Makan
-
Johannesburg, Gauteng, South Africa, 2001
- Recruiting
- Newtown Clinical Research
-
Johannesburg, Gauteng, South Africa, 2196
- Recruiting
- Sandton Medical Research
-
Johannesburg, Gauteng, South Africa, 2013
- Recruiting
- Wits Bara Clinical Trial Site
-
Lenasia, Gauteng, South Africa, 1827
- Active, not recruiting
- Lenasia Clinical Trial Centre
-
Pretoria, Gauteng, South Africa, 0186
- Recruiting
- Clinical Trial Systems (CTC)
-
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KwaZulu-Natal
-
Durban, KwaZulu-Natal, South Africa, 4450
- Recruiting
- Dr Pillay's Rooms
-
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Western Cape
-
Cape Town, Western Cape, South Africa, 7500
- Recruiting
- Tread Research (Pty)Ltd
-
Mossel Bay, Western Cape, South Africa, 6500
- Recruiting
- Dr Hendrik Snyman's Practice
-
Paarl, Cape Town, Western Cape, South Africa, 7646
- Recruiting
- Paarl Research Centre
-
Somerset West, Western Cape, South Africa, 7130
- Recruiting
- Clinical Trials Network Helderberg (Pty) Ltd
-
-
-
-
-
A Coruña, Spain, 15006
- Recruiting
- Complejo Hospitalario Universitario A Coruña
-
Antequera, Spain, 29200
- Recruiting
- Hospital Comarcal de Antequera
-
Barcelona, Spain, 08035
- Not yet recruiting
- Hospital Vall d'Hebron
-
Barcelona, Spain, 08028
- Recruiting
- CAPSBE_CAP Ernest LLuch
-
Centelles (Barcelona), Spain, 08540
- Recruiting
- Eap Osona Sud Alt Congost S.L.P
-
Girona, Spain, 17002
- Recruiting
- Clínica Bofill
-
Madrid, Spain, 28006
- Recruiting
- Hospital Universitario de la Princesa
-
Madrid, Spain, 28016
- Not yet recruiting
- Hospital Universitario Sanitas Virgen del Mar
-
Madrid, Spain, 28942
- Not yet recruiting
- Hospital Universitario de Fuenlabrada
-
Madrid, Spain, 28006
- Completed
- Hosp. Univ. Ruber Juan Bravo_Endocrinología
-
Manresa, Spain, 08243
- Recruiting
- Althaia Xarxa Assistencial Universitaria De Manresa Fundacio Privada
-
Málaga, Spain, 29010
- Not yet recruiting
- H. Clinico Univ. Virgen de la Victoria
-
Valladolid, Spain, 47004
- Recruiting
- Hosp. Recoletas Salud Campo Grande_Endoc y Nutric
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- Active, not recruiting
- Uni of Alabama at Birmingham
-
Pelham, Alabama, United States, 35124
- Active, not recruiting
- Cahaba Research
-
-
Arizona
-
Gilbert, Arizona, United States, 85296
- Active, not recruiting
- Elligo Health Research Inc
-
Phoenix, Arizona, United States, 85006
- Active, not recruiting
- Velocity Clinical Research-Phoenix
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- Active, not recruiting
- Arkansas Clinical Research
-
Little Rock, Arkansas, United States, 72211
- Active, not recruiting
- Woodland Int. Research Group
-
-
California
-
Escondido, California, United States, 92025
- Active, not recruiting
- Neighborhood Healthcare
-
Escondido, California, United States, 92025
- Active, not recruiting
- Headlands Research California, LLC
-
La Mesa, California, United States, 91942
- Active, not recruiting
- Diabetes & Endocrine Specialists - La Mesa
-
Lincoln, California, United States, 95648
- Active, not recruiting
- Clinical Trials Research_Sacramento
-
Loma Linda, California, United States, 92354
- Active, not recruiting
- Loma Linda University Faculty Medical Clinics
-
Los Alamitos, California, United States, 90720
- Active, not recruiting
- Pacific Clinical Studies
-
Northridge, California, United States, 91325
- Active, not recruiting
- Valley Clinical Trials
-
Palm Springs, California, United States, 92262
- Active, not recruiting
- Desert Oasis Healthcare
-
San Diego, California, United States, 92111
- Active, not recruiting
- Linda Vista Health Care Ctr
-
Van Nuys, California, United States, 91405
- Active, not recruiting
- Velocity Clin Res - Van Nuys
-
Walnut Creek, California, United States, 94598
- Active, not recruiting
- Flourish Research - CA
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Completed
- University of Colorado Hospital
-
-
Florida
-
Clearwater, Florida, United States, 33761
- Active, not recruiting
- TBMR & Alcanza
-
Fleming Island, Florida, United States, 32003
- Active, not recruiting
- Northeast Research Institute
-
Jacksonville, Florida, United States, 32204
- Active, not recruiting
- Northeast Research Institute
-
Jacksonville, Florida, United States, 32205
- Active, not recruiting
- Westside Center for Clinical Research
-
Miami, Florida, United States, 33165
- Active, not recruiting
- New Horizon Research Center
-
Miami, Florida, United States, 33155
- Active, not recruiting
- Bioclinical Research Alliance
-
Miramar, Florida, United States, 33027
- Active, not recruiting
- South Broward Research LLC
-
Ocoee, Florida, United States, 34761
- Active, not recruiting
- West Orange Endocrinology
-
Oviedo, Florida, United States, 32765
- Active, not recruiting
- Oviedo Medical Research, LLC
-
Pembroke Pines, Florida, United States, 33024
- Active, not recruiting
- Clinical Trial Services Corp
-
-
Georgia
-
Conyers, Georgia, United States, 30094
- Active, not recruiting
- Hope Clin Res & Wellness
-
Gainesville, Georgia, United States, 30501
- Active, not recruiting
- Center for Adv Res & Education
-
Roswell, Georgia, United States, 30076
- Active, not recruiting
- Endocrine Research Solutions, Inc
-
Woodstock, Georgia, United States, 30189-4255
- Active, not recruiting
- North Georgia Clinical Research
-
-
Idaho
-
Meridian, Idaho, United States, 83646
- Active, not recruiting
- Solaris Clinical Research
-
-
Illinois
-
Chicago, Illinois, United States, 60607
- Active, not recruiting
- Cedar-Crosse Research Center
-
Gillespie, Illinois, United States, 62033
- Active, not recruiting
- Macoupin Fam Practice Ctr, LLP
-
Gurnee, Illinois, United States, 60031
- Active, not recruiting
- Clinical Investigation Spec Gurnee
-
Skokie, Illinois, United States, 60077
- Active, not recruiting
- Evanston Premier Hlthcr Res
-
Skokie, Illinois, United States, 60077
- Active, not recruiting
- Endeavor Health
-
-
Iowa
-
West Des Moines, Iowa, United States, 50266
- Active, not recruiting
- Iowa Diabetes Research
-
-
Kansas
-
Newton, Kansas, United States, 67114
- Active, not recruiting
- Alliance for Multispecialty Research
-
Topeka, Kansas, United States, 66606
- Active, not recruiting
- Cotton O'Neil Diab & Endo Ctr
-
-
Kentucky
-
Lexington, Kentucky, United States, 40503
- Active, not recruiting
- The Research Group of Lexington LLC
-
-
Maryland
-
Rockville, Maryland, United States, 20852
- Not yet recruiting
- Endo and Metabolic Consultants
-
-
Michigan
-
Buckley, Michigan, United States, 49620
- Active, not recruiting
- Northern Pines Hlth Ctr, PC
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55416
- Not yet recruiting
- International Diabetes Center
-
Richfield, Minnesota, United States, 55423
- Active, not recruiting
- AES Minneapolis DRS
-
-
Mississippi
-
Belzoni, Mississippi, United States, 39038
- Active, not recruiting
- Belzoni Clinical Research
-
-
Missouri
-
Chesterfield, Missouri, United States, 63005
- Active, not recruiting
- Clinical Research Professionals
-
St Louis, Missouri, United States, 63128
- Active, not recruiting
- Amicis Centers of Clinical Research
-
-
New York
-
West Seneca, New York, United States, 14224
- Active, not recruiting
- Southgate Medical Group, LLP
-
-
North Carolina
-
Greensboro, North Carolina, United States, 27408
- Active, not recruiting
- PharmQuest Life Sciences LLC
-
Greenville, North Carolina, United States, 27834
- Active, not recruiting
- Physician's East Endocrinology
-
Morehead City, North Carolina, United States, 28557
- Active, not recruiting
- Carteret Medical Group
-
Morehead City, North Carolina, United States, 28557
- Active, not recruiting
- Centricity Rsrch MHCity Multi
-
Statesville, North Carolina, United States, 28625
- Active, not recruiting
- Piedmont Healthcare/Research
-
Wilmington, North Carolina, United States, 28401
- Active, not recruiting
- Accellacare Wilmington
-
-
North Dakota
-
Fargo, North Dakota, United States, 58104
- Active, not recruiting
- Lillestol Research LLC
-
Fargo, North Dakota, United States, 58104
- Not yet recruiting
- Plains Clinical Research Center, LLC
-
-
Ohio
-
Maumee, Ohio, United States, 43537
- Active, not recruiting
- Advanced Medical Research
-
-
Oklahoma
-
Norman, Oklahoma, United States, 73072
- Active, not recruiting
- Lynn Institute of Norman
-
Norman, Oklahoma, United States, 73069
- Active, not recruiting
- Alliance for Multispecialty Research
-
-
Pennsylvania
-
Beaver, Pennsylvania, United States, 15009
- Not yet recruiting
- Heritage Valley Medical Group
-
Hatboro, Pennsylvania, United States, 19040
- Active, not recruiting
- Hatboro Med Associates
-
Philadelphia, Pennsylvania, United States, 19114
- Active, not recruiting
- Northeast Endocrine Metabolic Associates
-
-
Rhode Island
-
Cumberland, Rhode Island, United States, 02864
- Active, not recruiting
- Clinical Res Collaborative
-
-
South Carolina
-
Gaffney, South Carolina, United States, 29340
- Active, not recruiting
- Velocity Clinical Research-Gaffney
-
Spartanburg, South Carolina, United States, 29303
- Active, not recruiting
- Spartanburg Medical Research
-
-
Tennessee
-
Jackson, Tennessee, United States, 38305
- Active, not recruiting
- Jackson Clinic
-
Kingsport, Tennessee, United States, 37660
- Active, not recruiting
- Holston Medical Group
-
Memphis, Tennessee, United States, 38119
- Active, not recruiting
- CNS Healthcare
-
Morristown, Tennessee, United States, 37813
- Active, not recruiting
- HealthStar Physicians, PC
-
Nashville, Tennessee, United States, 37203
- Active, not recruiting
- Clinical Research Associates
-
-
Texas
-
Amarillo, Texas, United States, 79124
- Active, not recruiting
- Amarillo Med Spec LLP
-
Austin, Texas, United States, 78731
- Active, not recruiting
- Texas Diab & Endo, P.A.
-
Austin, Texas, United States, 78759
- Active, not recruiting
- Velocity Clinical Research Austin
-
Dallas, Texas, United States, 75230
- Active, not recruiting
- Velocity Clin Res, Dallas
-
Dallas, Texas, United States, 75231
- Active, not recruiting
- North Texas Endocrine Center
-
Euless, Texas, United States, 76040
- Active, not recruiting
- Cedar Health Research
-
Houston, Texas, United States, 77079
- Active, not recruiting
- The Endocrine Center
-
Houston, Texas, United States, 77040
- Active, not recruiting
- JCCT- Juno NW Houston
-
Katy, Texas, United States, 77450
- Active, not recruiting
- Medical Colleagues-Texas LLP
-
Kerrville, Texas, United States, 78028
- Active, not recruiting
- Sante Clinical Research
-
Lampasas, Texas, United States, 76550
- Active, not recruiting
- Radiance Clinical Research
-
Laredo, Texas, United States, 78041
- Active, not recruiting
- Aeres Clinical Research
-
Longview, Texas, United States, 75605
- Active, not recruiting
- DCOL Ctr for Clin Res
-
McAllen, Texas, United States, 78503
- Active, not recruiting
- RGV Endocrine Center
-
San Antonio, Texas, United States, 78229
- Active, not recruiting
- AES San Antonio
-
San Antonio, Texas, United States, 78233
- Active, not recruiting
- Northeast Clinical Research of San Antonio
-
San Antonio, Texas, United States, 78209
- Active, not recruiting
- Quality Research Inc
-
Shavano Park, Texas, United States, 78231
- Active, not recruiting
- Consano Clinical Research, LLC
-
Sugar Land, Texas, United States, 77478
- Active, not recruiting
- Mt Olympus Medical Research, LLC
-
-
Utah
-
Salt Lake City, Utah, United States, 84109
- Active, not recruiting
- J.Lewis Research Inc
-
Salt Lake City, Utah, United States, 84121
- Active, not recruiting
- J.Lewis Research Inc
-
Sandy City, Utah, United States, 84093
- Active, not recruiting
- Diabetes & Endo Tx Specialists
-
South Jordan, Utah, United States, 84095
- Active, not recruiting
- J.Lewis Research Inc
-
-
Virginia
-
Newport News, Virginia, United States, 23606
- Active, not recruiting
- Health Res of Hampton Roads
-
Newport News, Virginia, United States, 23606
- Active, not recruiting
- Tidewater Physicians Multispecialty Group
-
Richmond, Virginia, United States, 23294
- Active, not recruiting
- National Clin Res Inc.
-
-
Wisconsin
-
Green Bay, Wisconsin, United States, 54303
- Not yet recruiting
- 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 (sex assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent.
- BMI≥ 35.0 kg/m^2.
- Participants without T2D: No history of T2D and HbA1c < 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c < 10% (< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.
Exclusion Criteria:
- A self-reported change in body weight > 5% within 90 days before screening, irrespective of medical records.
- Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.
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 - dose level 1
Participants will receive CagriSema at dose level 1 once weekly subcutaneously during the treatment period for 72 weeks.
|
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
|
|
Active Comparator: Cagrisema - dose level 2
Participants will receive CagriSema at dose level 2 once weekly subcutaneously during the treatment period for 72 weeks.
|
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
|
|
Active Comparator: Semaglutide
Participants will receive Semaglutide once weekly subcutaneously during the treatment period for 72 weeks.
|
Semaglutide will be administered subcutaneously.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative change in body weight
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured as percentage (%).
|
From randomisation (week 0) to end of treatment (week 72)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Relative change in body weight
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured as %.
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Change in Body Mass Index (BMI)
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured as kilograms per square metre (kg/m^2).
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Number of participants who achieve greater than or equal to (≥) 30% weight reduction
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured as count of participants.
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Number of participants who achieve ≥25% weight reduction
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured as count of participants.
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Number of participants who achieve greater ≥ 20% weight reduction
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured as count of participants.
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Change in waist circumference
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured in centimetre (cm).
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Mean change in body weight
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured in kilograms (kg).
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Number of participants who achieve a BMI less than (<) 30 kg/m^2
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured as count of participants.
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Number of participants who achieve BMI <27 kg/m^2
Time Frame: end of treatment (week 72)
|
Measured as count of participants.
|
end of treatment (week 72)
|
|
Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2
Time Frame: At end of treatment (week 72)
|
Measured as count of participants.
|
At end of treatment (week 72)
|
|
Number of participants who achieve a waist-to-height ratio < 0.53
Time Frame: At end of treatment (week 72)
|
Measured as count of participants.
|
At end of treatment (week 72)
|
|
Ratio to baseline : Total cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 72)
|
Measured in terms of ratio.
|
From baseline (week 0) to end of treatment (week 72)
|
|
Ratio to baseline : High density lipoprotein (HDL) cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 72)
|
Measured in terms of ratio.
|
From baseline (week 0) to end of treatment (week 72)
|
|
Ratio to baseline : Low density lipoprotein (LDL) cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 72)
|
Measured in terms of ratio.
|
From baseline (week 0) to end of treatment (week 72)
|
|
Ratio to baseline : Very low density lipoprotein ( VLDL) cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 72)
|
Measured in terms of ratio.
|
From baseline (week 0) to end of treatment (week 72)
|
|
Ratio to baseline : Triglycerides
Time Frame: From baseline (week 0) to end of treatment (week 72)
|
Measured in terms of ratio.
|
From baseline (week 0) to end of treatment (week 72)
|
|
Ratio to baseline: Free fatty acids
Time Frame: From baseline (week 0) to end of treatment (week 72)
|
Measured in terms of ratio.
|
From baseline (week 0) to end of treatment (week 72)
|
|
Ratio to baseline : Non-HDL cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 72)
|
Measured in terms of ratio.
|
From baseline (week 0) to end of treatment (week 72)
|
|
Change in Short-Form-36 Health Survey Version 2.0 (SF-36v2) physical Function
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured as score on a scale.
The SF-36v2 acute measures health-related quality of life (HRQOL).
The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores.
SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 United States general population has a mean of 50 and a standard deviation of 10.
Physical functioning score ranges from 19.0-57.6, with higher scores indicating better functional health and well-being.
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) physical function
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured as score on a scale.
IWQOL-Lite-CT measures weight-related physical and psychosocial functioning.
The measure consists of 20 items yielding 3 composite scores, and 1 total score.
Physical function score ranges from 0 to 100, with higher scores indicating better levels of functioning.
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Change in glycated haemoglobin (HbA1c)
Time Frame: From randomisation (week 0) to end of treatment (week 72)
|
Measured in %-points.
|
From randomisation (week 0) to end of treatment (week 72)
|
|
Number of participants who achieve HbA1c <6.5%
Time Frame: At end of treatment (week 72)
|
Measured as count of participants.
|
At end of treatment (week 72)
|
|
Number of participants who achieve normal HbA1c <5.7%
Time Frame: At end of treatment (week 72)
|
Measured as count of participants.
|
At end of treatment (week 72)
|
|
Number of treatment-emergent adverse events (TEAEs)
Time Frame: From randomisation (week 0) to end of study (week 80)
|
Measured in number of events.
|
From randomisation (week 0) to end of study (week 80)
|
|
Number of treatment-emergent serious adverse events (TESAEs)
Time Frame: From randomisation (week 0) to end of study (week 80)
|
Measured in number of events.
|
From randomisation (week 0) to end of study (week 80)
|
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)
May 21, 2026
Primary Completion (Estimated)
February 23, 2028
Study Completion (Estimated)
April 19, 2028
Study Registration Dates
First Submitted
April 27, 2026
First Submitted That Met QC Criteria
April 27, 2026
First Posted (Actual)
May 4, 2026
Study Record Updates
Last Update Posted (Actual)
August 31, 2026
Last Update Submitted That Met QC Criteria
August 27, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN9838-7910
- 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- U1111-1323-0372 (Other Identifier: World Health Organization)
- 2025-522488-14 (Other Identifier: European Medical Agency (EMA))
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.