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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

2,734

Participants

Timeline

Start Date

September 27, 2023

Primary Completion Date

November 17, 2025

Study Completion Date

January 5, 2026

Conditions
Type 2 Diabetes Mellitus
Interventions
DRUG

Cagrilintide

Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose 1 and dose 2 of cagrilintide is reached.

DRUG

Semaglutide

Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose 1 and dose 2 of semaglutide is reached.

DRUG

Placebo cagrilintide

Participants will receive placebo matched to cagrilintide subcutaneously.

DRUG

Placebo semaglutide

Participants will receive placebo matched to semaglutide subcutaneously.

Trial Locations (354)

110

Taipei Medical University Hospital, Taipei

500

Changhua Christian Hospital_Metabolic Dept., Changhua

1000

Dermatologija Bartenjev, Ljubljana

1036

Óbudai Egészségügyi Centrum, Budapest

1106

Bajcsy-Zsilinszky Kórház, Budapest

1134

MH Egészségügyi Központ, Budapest

1202

Diagnostic Consulting Center Ascendent, Sofia

1330

Healthcare centre Kocevje, Kočevje

1619

Clinresco Centres (Pty) Ltd, Kempton Park

1756

"Medical Center Maraya Med EOOD", Sofia

2000

UKC Maribor - diabetes, Maribor

2001

Newtown Clinical Research, Johannesburg

2010

Momentum Clinical Research Darlinghurst, Darlinghurst

2050

Clinical Research Facility, Charles Perkins Centre, Camperdown

2109

Macquarie University, Macquarie Park

2196

Sandton Medical Research, Johannesburg

2291

Hunter Diabetes Centre, Merewether

2400

Bispebjerg Hospital, IC-Forskning, Copenhagen

2650

Hvidovre Hospital Endokrinologisk forsk. afs. 159, Hvidovre

2730

Steno Diabetes Center Copenhagen, Herlev

2900

Dr. Tatyana Metalova - AIPSMCE EOOD, Gotse Delchev

3004

Baker Heart and Diabetes Institute, Melbourne

3065

St Vincent's Hospital - Melbourne, Fitzroy

3326

Hospital Topolšica, Topolšica

3400

Hillerød Endokrinologisk amb. H0652, Hillerød

3600

Medical Center Zdrave Lom, Lom

4032

Debreceni Egyetem Belgyógyászati Klinika, Debrecen

4131

Logan Hospital, Meadowbrook

5000

Steno Diabetes Center Odense, Odense C

Healtcare Centre Nova Gorica, Nova Gorica

5046

Southern Adelaide Diabetes & Endocrine Services, Oaklands Park

6000

Healthcare Centre Koper, Koper

6001

Phoenix Pharma, Port Elizabeth

6725

Szegedi Tudomanyegyetem St Györgyi Albert Klinikai Központ, Szeged

7200

Medical centre Razgrad OOD, Razgrad

7400

Kaposi Mór Oktató Kórház, Kaposvár

7646

Paarl Research Centre, Paarl, Cape Town

8000

IPSMC - Dr. Nikolay Kostadinov EOOD, Burgas

8200

Aarhus Universitetshospital, Steno Diabetes Center Aarhus, Aarhus N

9000

Medical centre Clinic Nova, Varna

9010

UMHAT Sveta Marina EAD, Varna

9700

Vas Vármegyei Markusovszky Egyetemi Oktatókórház, Szombathely

10000

Poliklinika Solmed, Zagreb

11000

CHC Zvezdara, Clinical department for endocrinology, Belgrade

Endocrinology, Diabetes and Metabolism Diseases Clinic, Belgrade

11080

Clinical Hospital Center Bezanijska Kosa, Belgrade

11527

"Laiko General Hospital of Athens", Athens

General hospital of Athens 'G.Gennimatas', Athens

12203

AMC Community Endocrinology, Albany

12462

University Hospital of Athens ATTIKON, Athens

13057

Velocity Clin Res Syracuse, East Syracuse

13597

Medizinisches Versorgungszentrum Am Bahnhof Spandau GbR, Berlin

14224

Southgate Medical Group, LLP, West Seneca

14647

The Catholic University of Korea, Bucheon ST. Mary's Hospital, Bucheon-si

14787

Great Lakes Medical Research, Westfield

15006

Complejo Hospitalario Universitario A Coruña, A Coruña

15125

Iatriko Athinon (Athens Medical Canter), Athens

20132

Istituto Scientifico San Raffaele, Milan

20157

Azienda Ospedaliera Luigi Sacco, Milan

20520

Turku University Hospital, Turku

21000

Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis., Novi Sad

21109

Diabetes-Zentrum-Wilhelmsburg GbR, Hamburg

21200

Centro de investigación en Artritis y Osteoporosis S.C., Mexicali

22041

Diabetes Zentrum Wandsbek Berufsausuebungsgemeinschaft GbR, Hamburg

23538

Uniklinik Schleswig-Holstein - Medizinischen Klinik I am Campus Lübeck, Lübeck

23606

TPMG Clinical Research, Newport News

23758

RED-Institut für medizinische Forschung und Fortbildung GmbH, Oldenburg in Holstein

24127

Azienda Ospedaliera Papa Giovanni XXIII, Bergamo

26040

Eskisehir Osmangazi University School of Medicine, Eskişehir

27408

PharmQuest Life Sciences LLC, Greensboro

27514

University of North Carolina, Chapel Hill

28401

Accellacare, Wilmington

28557

Carteret Medical Group, Morehead City

28625

Piedmont Healthcare/Research, Statesville

28935

Hospital Universitario de Móstoles, Móstoles

29303

Spartanburg Medical Research, Spartanburg

Velocity Clin Res Spartanburg, Spartanburg

29340

Velocity Clin Res Gaffney, Gaffney

29621

AnMed Health IMA, Anderson

Synexus Clin Res US-Anderson, Anderson

Velocity Clinical Res-Anderson, Anderson

30076

Endocrine Research Solutions, Inc., Roswell

Endocrine Research Solutions, Roswell

30094

Hope Clin Res & Wellness, Conyers

31000

Poliklinika SLAVONIJA OSIJEK, Osijek

31210

East Coast Institute for Res, Macon

32204

Northeast Research Institute, Jacksonville

32763

Optimal Research Sites, Orange City

32804

Advent Health-Res Inst, Orlando

AdventHealth Diab Inst, Orlando

33027

South Broward Research LLC, Miramar

33100

Pihlajalinna Koskiklinikka, Tampere

Terveystalo Tampere Rautatienkatu, Tampere

33144

Clinical Trial Services Corp, Miami

33155

Bioclinical Research Alliance, Miami

33165

New Horizon Research Center, Miami

34000

Clinical Centre Kragujevac, Internal Diseases Clinic, Endocrinology department, Kragujevac

Clinical Centre Kragujevac, Internal Diseases Clinic, Endocr, Kragujevac

34098

Haseki Sultangazi, Istanbul

34371

Seyrantepe Hamidiye Etfal Egitim ve Arastirma Hastanesi, Istanbul

34390

Istanbul Universitesi Istanbul Tip Fakultesi - Endokrinoloji, Istanbul

34480

Basaksehir Cam ve Sakura Sehir Hastanesi, Istanbul

34722

T.C SB Goztepe Prof. Dr. Suleyman Yalcin City Hospital, Istanbul

34761

West Orange Endocrinology, Ocoee

35124

Cahaba Research, Pelham

35152

Linn clinic - Clalit Health Services, Haifa

Linn clinic - Diabetes Unit, Haifa

35294

Univ of Alabama_Birmingham, Birmingham

37203

Clinical Research Associates, Nashville

37660

Holston Medical Group, Kingsport

39503

Velocity Clin Res Gulfport, Gulfport

40002

Hospital General de Segovia, Segovia

40100

Terveystalo Jyväskylä, Jyväskylä

41010

Hospital Infanta Luisa, Seville

41110

Univ Gen Hospital Larisa, Larissa

42415

Yeungnam University Medical Center, Daegu

43213

Centricity Research, Columbus

44137

Diabeteszentrum-Do Dres. K U. Ch. Busch GbR, Dortmund

44311

Radiant Research Inc. - Akron, Akron

44670

Centro de Investigacion Clinica Endocrinologica de Jalisco, Guadalajara

45136

InnoDiab Forschung GmbH, Essen

46026

Hospital La Fe - Endocrinología y Nutrición, Valencia

49808

Diabetologische Gemeinschaftspraxis Dr. Staudenmeyer und Dr. Schiwietz, Lingen

50082

Dr P V Rao - Diabetes Research Centre, Hyderabad

50134

AOU Careggi Firenze, Florence

AOU Careggi Firenze, Florence

50266

Iowa Diabetes & Endo Res Ctr, West Des Moines

52100

Azienda Sanitaria Usl Toscana Sud Est - Ospedale San Donato, Arezzo

52621

Sheba MC - Endocrinology Clinic, Tel Litwinsky

53020

Recep Tayyip Erdoğan Üni. Eğitim ve Araştırma Hastanesi, Rize

54303

St. Vincent Hosp-Prevea Health, Green Bay

54621

"AHEPA University Hospital of Thessaloniki", Thessaloniki

54636

"AHEPA University Hospital of Thessaloniki", Thessaloniki

54642

"Ippokrateio G.H. of Thessaloniki", Thessaloniki

54645

EUROMEDICA Gen Clinic The/ki, Endocrin,Metabolism,Diabetes, Thessaloniki

56429

General Hospital Of Thessaloniki Papageorgiou, Nea Efkarpia

57567

Diabetologische Schwerpunktpraxis Daaden, Daaden

58100

Wolfson MC - Diabetes Clinic, Holon

59030

Tekirdag Namık Kemal UTF, Tekirdağ

60031

Clinical Invest Special_Gurnee, Gurnee

60077

Endeavor Health, Skokie

Evanston Premier Hlthcr Res, Skokie

60220

Seinäjoen keskussairaala, Seinäjoki

60607

Cedar-Crosse Research Center, Chicago

63017

Diabetes & Endo Specialists Inc, Chesterfield

63571

MVZ Diabeteszentrum Dr. Tews GmbH, Gelnhausen

66100

Università degli studi G. D'Annunzio Chieti Pescara - CAST, Chieti Scalo

66606

Cotton-O'Neil Diab & Endo Ctr, Topeka

67059

Die Praxis am Ludwigsplatz, Ludwigshafen

67114

Alliance for Multispec Res, Newton

70508

Velocity Clin Res Lafayette, Lafayette

72205

Arkansas Clinical Research, Little Rock

73069

Alliance for Multispec Res, Norman

75230

Velocity Clinical Res-Dallas, Dallas

75231

North Texas Endocrine Center, Dallas

75234

Synexus Clin Res Dallas, Dallas

75251

Cedar Health Research, Dallas

76100

Kaplan MC - Metabolic Unit, Rehovot

Kaplan MC, Rehovot

76901

Diahaza s.r.o., Holešov

77040

Juno Research, LLC_Houston, Houston

77061

Synergy Groups Medical, Houston

77079

PlanIt Research, PLLC, Houston

77375

DM Clin Rsrch/Fam Diag Clinic, Tomball

77450

Medical Colleagues-Texas LLP, Katy

77459

Discovery MMS Services, INC, Missouri City

78028

Sante Clinical Research, Kerrville

78229

AES San Antonio, San Antonio

University of Texas San Antonio, San Antonio

78231

Consano Clinical Research, LLC, Shavano Park

78233

NE Clin Res of San Antonio, San Antonio

78759

Velocity Clin Res Austin, Austin

80131

Azienda Ospedaliera Universitaria Federico II di Napoli, Napoli

80906

Optumcare Clinical Trials,LLC-Golden, Colorado Springs

81667

Medicover Neuroendokrinologie MVZ München, München

83646

Solaris Clinical Research, Meridian

83702

St. Luke's Health System, Boise

84088

Velocity Clin Res-Salt Lk City, West Jordan

84093

Diabetes & Endo Treatment Spec, Sandy City

85006

Velocity Clinical Research-Phoenix, Phoenix

85020

Synexus Rsch /Cnt Phnx Med C, Phoenix

87107

Velocity Clin Res Albuquerque, Albuquerque

88100

Azienda Ospedaliero-Universitaria Renato Dulbecco, Catanzaro

90101

MediVet s.r.o., Malacky

90127

AOUP Giaccone Palermo, Palermo

Dip. di Medicina Interna Policlinico Universitario Palermo, Palermo

90247

Velocity Clin Res Gardena, Gardena

91120

Hadassah Ein Karam MC - Diabetes Unit, Jerusalem

91345

Facey Medical Foundation, Mission Hills

91355

Desert Oasis Hlthcr Med Group, Palm Springs

91405

Velocity Clin Res - Panorama, Van Nuys

91602

Premier Medical Center, Inc., Toluca Lake

91911

Velocity Clin Res-Chula Vista, Chula Vista

91942

Velocity Clin Res San Diego, La Mesa

92025

Headlands Research California, LLC, Escondido

92111

Linda Vista Health Care Ctr, San Diego

92220

Velocity Clinical Res-Banning, Banning

92262

Desert Oasis Hlthcr Med Group, Palm Springs

92354

Loma Linda Univ Hlth Cr Endo, Loma Linda

92408

Velocity Clin Res- San Bern, San Bernardino

92704

Velocity Clin Res Santa Ana, Santa Ana

94520

John Muir Physicians Network, Concord

98057

Rainier Clin Res Ctr Inc, Renton

100050

Beijing Friendship Hospital, Capital Medical University-Endocrinology, Beijing

100179

Diabmed Dr Popescu Alexandrina SRL, Ploieşti

100342

CMI Dr. Busegeanu Mihaela Magdalena, Ploieşti

100853

Chinese People's Liberation Army General Hospital-Endocrinology, Beijing

200349

Urodiamed SRL, Craiova

210011

The Second Affiliated Hospital of Nanjing Medical University-Endocrinology, Nanjing

212001

The Affiliated Hospital of Jiangsu University-Endocrinology, Zhenjiang

215002

Suzhou Municipal Hospital-Endocrinology, Suzhou

250000

Jinan Central Hospital, Ji'Nan

Jinan Central Hospital Affiliated to Shandong University, Jinan

302004

SMS Medical College & Hospital, Jaipur

390013

Swasthya Diabetes Care, Ahmedabad

400006

Spitalul Clinic Judetean Urgenta Cluj-Napoca, Cluj-Napoca

404000

Chongqing University Three Gorges Hospital, Chongqing

421004

Ashirwad Hospital and Research Centre, Thāne

450112

Cabinet Medical de Diabet, Nutritie si Boli Metabolice-Dr. Zaharie Daniela Gabriela, Zalău

475000

Huaihe Hospital of Henan University-Endocrinology, Kaifeng

500004

Gleneagles Hospitals, Hyderabad

500101

Mariodiab Clinic SRL, Brasov

500283

Centrul Medical de Diagnostic si Tratament Ambulatoriu Neomed, Brasov

520002

Yalamanchi Hospitals and Research centres pvt ltd, Vijaywada

545300

Poli Cardinal Med Srl, Reghin

560066

Lifecare Hospital and Research Centre, Bengaluru

570001

K R Hospital, Mysuru

600086

Madras Diabetes Research Foundation, Chennai

600154

CMI Dr. Pletea Noemi SRL, Bacau

700054

Apollo Multispeciality Hospital, Kolkata, Kolkata

705200

Bella Praxis S.R.L., Paşcani

781032

Gauhati Medical College and Hospital, Guwahati

800001

S.C Milena Sante SRL, Galati

4630945

Clalit sick fund Herzeliya, Herzeliya

Clalit sick fund Herzlia, Herzliya

02740

BTC of New Bedford, LLC, New Bedford

08611

Premier Research Inc., Trenton

02864

Clinical Res Collaborative, Cumberland

02818

Velocity Clin Res Providence, East Greenwich

37620-7352

Holston Medical Group Pc, Bristol

76012-4637

Arlington Family Res. Ctr Inc, Arlington

C1128 AAF

Mautalen Salud e investigación, CABA

C1180AAX

Sanatorio Güemes, CABA

S2000CUD

Instituto de Investigaciones Clínicas Rosario, Rosario

C1023AAB

STAT Research, Buenos Aires

C1425AGC

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli, Buenos Aires

C1061AAS.

Centro de Investigación y Prevención Cardiovascular, CABA

80030-480

Cline Research Center, Curitiba

01228-000

CPQuali Pesquisa Clínica Ltda, São Paulo

01228-200

CPCLIN - Centro de Pesquisas Clínicas, São Paulo

T2H 2G4

Centricity Research Calgary, Calgary

V3R 4H6

Guilford Med Clinic, Surrey

V3T 2V6

TLC Diabetes and Endocrinology, Surrey

V3Z 2N6

Ocean West Research Clinic, Surrey

V4A 0C1

Hilltop Medical Clinic, Surrey

V6Z 2T1

Spectrum Health Clinic, Vancouver

E1G 1A7

G.A. Research Associates Ltd., Moncton

L4N 7L3

Centricity Res. Barrie Endo, Barrie

L6S 0C6

Centricity Research Brampton, Brampton

L4K 4M2

Centricity Research Vaughn Endocrinology, Concord

L1E2J5

Medical Trust Clinics, Inc., Courtice

M9R 4E1

Centricity Research Etobicoke, Etobicoke

N5W 6A2

Milestone Research, London

N6G 2M1

Western Univ. Cnt for Studies in Fam Med, London

K2J 0V2

Centricity Research Ottawa LMC, Nepean

M4G 3E8

Centricity Research Toronto, Toronto

M6G 1M2

Diabetes Heart Research Centre, Toronto

H4N 2W2

Centre Medical Acadie, Montreal

H9R 4S3

Centricity Res Pointe-Claire, Pointe-Claire

G3K 2P8

ALPHA Recherche Clinique, Québec

J6X 4P7

Ctr de Med Metab de Lanaudiere, Terrebonne

G6P 3Z8

Diex Recherche Victoriaville, Victoriaville

G1V 4T3

Diex Recherche Quebec Inc., Québec

G1V 4W2

Clin des Mal Lipid de Quebec, Québec

G1W 4R4

Centre de Recherche Saint-Louis, Québec

51 000

KBC Rijeka, Endokrinologija, Rijeka

51 410

Specijalna bolnica Thalassotherapia, Opatija

35 000

General Hospital Dr. Josip Bencevic_Diabetic department, Slavonski Brod

42 000

Opca bolnica Varazdin_Endocrinology, Varaždin

140 21

IKEM Centrum Diabetologie, Prague

602 00

Fakultní nemocnice U sv. Anny v Brně, Brno

550 01

Edumed Broumov, Broumov

301 00

DIALINE s.r.o., Plzeň 3

110 00

Diabet2 s.r.o., Prague

140 00

MUDr. Michala Pelikanova, Prague

01307

Uniklinik TU Dresden - Med. Klinik III, Dresden

04910

Zentrum fuer klinische Studien Suedbrandenburg GmbH, Elsterwerda

115 25

Iatriko Psychicou Private Clinic, Athens

00161

Azienda Ospealiero Universitaria Policlinico Umberto I, Roma

00168

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Dipartimento di scienze Mediche e Chirurgiche, Rome

963-8851

Seino Internal Medicine Clinic_Internal medicine, Koriyama-shi

870 0039

Abe Diabetes Clinic_Internal Medicine, Ōita

260-0804

Akaicho Clinic, Chiba-shi, Chiba

311-0113

Naka Kinen Clinic_Internal medicine, Ibaraki

Naka Kinen Clinic, Ibaraki

311-4153

Minami Akatsuka Clinic, Mito-shi, Ibaraki

530-8480

Medical Research Institute KITANO HOSPITAL, Diabetes & Endocrinology, Osaka-shi, Osaka

103-0027

Tokyo-Eki Center-building Clinic_Internal Medicine, Tokyo

104-0031

Fukuwa Clinic_Internal Medicine, Tokyo

Fukuwa Clinic, Tokyo

32-500

Malopolskie Centrum Sercowo-Naczyniowe, Chrzanów

66-400

Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski, Gorzów Wielkopolski

02-117

Instytut Diabetologii Sp. z o.o., Warsaw

35-055

Centrum Medyczne Medyk Sp. z o.o., Rzeszów

15-351

Osteo Medic s.c. Artur Racewicz Jerzy Supronik, Bialystok

15-435

NZOZ Specjalistyczny Osrodek Internistyczno-Diabetologiczny Małgorzata Arciszewska, Bialystok

41-300

PAKS III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii, Dąbrowa Górnicza

43-100

PAKS III Oddział Kardiologii Inwazyjnej, Angiologii i Elektrokardiologii, Tychy

20-362

Velocity Nova Sp. z o.o., Lublin

24-100

KO-MED Centra Kliniczne Sp. z o.o., Puławy

28-200

Velocity Nova Sp. z o.o., Staszów

Velocity Nova Sp. z o.o., Staszów

00-710

NBR Polska Tomasz Klodawski, Warsaw

02-507

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji, Warsaw

93-513

Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika, Lodz

020475

Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila, Bucharest

050913

Diabet Med SRL, Bucharest

08501

DIADA, s.r.o., Bardejov

040 01

Diabetologicka ambulancia DIOLI s.r.o., Košice

DIOLI s.r.o., Košice

080 01

DIALIPID, s.r.o., Prešov

971 01

MUDr. Jan Culak, s.r.o., Prievidza

034 01

DIACENTRUM, s.r.o., Ružomberok

083 01

MEDI-DIA s.r.o., Sabinov

942 01

DEImedi, s. r. o., Šurany

075 01

ARETEUS s.r.o., Trebišov

965 01

iDia s. r. o., Žiar nad Hronom

0186

Clinical Trial Systems (CTC), Pretoria

501-717

Chosun University Hospital, Gwangju

02447

Kyunghee University Medical Center, Seoul

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03181

Kangbuk Samsung Hospital, Seoul

08035

Hospital Vall d'Hebron, Barcelona

08430

ABS La Roca del Vallés_Endocrinología, La Roca Del Vallés

222 21

Clemenstorgets Hjärtmottagning, Lund

205 02

Forskningsmottagning Internmedicin (tidigare KFE), Malmo

431 53

CTC GoCo Mölndal, Mölndal

701 85

Överviktsenheten Örebro universitetssjukhus, Örebro

171 64

Karolinska Universitetssjukhuset Solna,FOU Tema Hjärta Kärl, Stockholm

01790

Cukurova Universitesi Tip Fakultesi, Adana

07058

Akdeniz University Tip Fakultesi Hastanesi, Antalya

SG1 4AB

Lister Hospital, Stevenage

YO18 8BL

Pickering Medical Practice, Pickering

AB25 2ZP

Aberdeen Royal Infirmary - Grampian Diabetes Research Unit, Aberdeen

Aberdeen Royal Infirmary, Aberdeen

BA2 3HT

Oldfield Surgery, Bath

BB2 1AX

Oakenhurst Surgery, Blackburn

DD1 9SY

Ninewells Hospital, Dundee

L9 7AL

University Hospital Aintree, Liverpool

NR4 7UY

Norfolk and Norwich University Hospital Trust, Norwich

SO30 3JB

Moorgreen Hospital, Southampton

SA2 8PP

Joint Clinical Research Facility - Swansea, Swansea

TR1 3LJ

Royal Cornwall Hospital (Treliske), Truro

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY