A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

April 8, 2024 updated by: Novo Nordisk A/S

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 2.4 mg/2.4 mg s.c. Once Weekly Versus Tirzepatide 15 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

This study will look at how well CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

Study Overview

Status

Recruiting

Conditions

Type 2 Diabetes

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

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

Argentina
- - Buenos Aires, Argentina, C1012AAR
    - Recruiting
    - Instituto de Investigaciones Metabolicas (Idim)
  - Caba, Argentina, C1060ABA
    - Not yet recruiting
    - Centro de Investigación Clínica
  - Caba, Argentina, C1060ABA
    - Recruiting
    - Centro de Investigación Clínica
  - Ciudad Autonoma de Buenos Aires, Argentina, C1405BUB
    - Not yet recruiting
    - CICEMO- Consultorio de Investigación Clínica EMO
  - Ciudad Autonoma de Buenos Aires, Argentina, C1015
    - Recruiting
    - OMI- Organización Médica de Investigación
  - Ciudad Autonoma de Buenos Aires, Argentina, C1405BUB
    - Recruiting
    - CICEMO- Consultorio de Investigación Clínica EMO
  - Mar del Plata, Argentina, B7600FZN
    - Recruiting
    - Instituto de Investigaciones Clinicas
  - Santa Fe, Argentina, S3000FSO
    - Recruiting
    - CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
- Buenos Aires
  - Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1061AAE
    - Recruiting
    - Buenos Aires Mácula
  - Ciudad de Buenos Aires, Buenos Aires, Argentina, C1405CWB
    - Recruiting
    - Instituto Medico Especializado_Capital Federal
Australia
- New South Wales
  - Blacktown, New South Wales, Australia, 2148
    - Recruiting
    - Paratus Clinical
  - Kanwal, New South Wales, Australia, 2259
    - Recruiting
    - Paratus Clinical
  - Merewether, New South Wales, Australia, 2291
    - Recruiting
    - Hunter Diabetes Centre
  - St Leonards, New South Wales, Australia, 2065
    - Not yet recruiting
    - Royal North Shore Hospital
- Queensland
  - Douglas, Queensland, Australia, 4814
    - Not yet recruiting
    - Townsville Hospital
  - Morayfield, Queensland, Australia, 4506
    - Not yet recruiting
    - University of Sunshine Coast
  - Taringa, Queensland, Australia, 4068
    - Not yet recruiting
    - Austrials
- South Australia
  - Oaklands Park, South Australia, Australia, 5046
    - Not yet recruiting
    - Southern Adelaide Diabetes & Endocrine Services
- Victoria
  - Parkville, Victoria, Australia, 3050
    - Not yet recruiting
    - The Royal Melbourne Hospital
  - St Albans, Victoria, Australia, 3021
    - Recruiting
    - Austrials
Canada
- - 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
- 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
    - Not yet recruiting
    - Hilltop Medical Clinic
  - Surrey, British Columbia, Canada, V3R 4H6
    - Not yet recruiting
    - Guilford Med Clinic
- New Brunswick
  - Moncton, New Brunswick, Canada, E1G 1A7
    - Recruiting
    - G.A. Research Associates Ltd.
- Ontario
  - Brampton, Ontario, Canada, L6S 0C6
    - Recruiting
    - Centricity Research Brampton
  - London, Ontario, Canada, N5W 6A2
    - Recruiting
    - Milestone Research
  - London, Ontario, Canada, N6G 2M1
    - Not yet recruiting
    - Western Univ. Cnt for Studies in Fam Med
  - Sarnia, Ontario, Canada, N7T 4X3
    - Recruiting
    - London Road Diagnostic Clinic and Medical Centre
  - 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
  - Quebec City, Quebec, Canada, G3K 2P8
    - Recruiting
    - ALPHA Recherche Clinique
  - Terrebonne, Quebec, Canada, J6X 4P7
    - Recruiting
    - Ctr de Med Metab de Lanaudiere
  - Victoriaville, Quebec, Canada, G6P 6P6
    - Not yet recruiting
    - Diex Recherche Victoriaville
- West Oshawa
  - Barrie, West Oshawa, Canada, L4N 7L3
    - Withdrawn
    - Centricity Research Oshawa
Colombia
- - Barranquilla, Colombia, 80001
    - Not yet recruiting
    - Cimedical
  - Barranquilla, Colombia, 80020
    - Not yet recruiting
    - Clinica de la Costa
  - Bogotá, Colombia, 110221
    - Not yet recruiting
    - Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S.
  - Bogotá, Colombia, 110221
    - Not yet recruiting
    - UNIENDO
- Santander
  - Floridablanca, Santander, Colombia, 681004
    - Withdrawn
    - FOSCAL
Czechia
- - Hlučín, Czechia, 74801
    - Withdrawn
    - LESTELA HLUČÍN, s.r.o.
  - Hradec Kralove, Czechia, 500 03
    - Withdrawn
    - Fakultni nemocnice Hradec Kralove
  - Olomouc, Czechia, 779 00
    - Withdrawn
    - Diabetologické centrum s.r.o.
  - Praha 10, Czechia, 100 00
    - Withdrawn
    - Fakultni nemocnice Kralovske Vinohrady
  - Praha 6, Czechia, 160 00
    - Withdrawn
    - Fledip s.r.o.
  - Trutnov, Czechia, 541 01
    - Withdrawn
    - Intendia s.r.o.
  - Valašské Klobouky, Czechia, 76601
    - Withdrawn
    - Interní a diabetologická ordinace
France
- - Paris, France, 75014
    - Withdrawn
    - Gie Groupe Hospitalier Paris Saint-Joseph/Vinci
  - Pierre Benite, France, 69310
    - Withdrawn
    - Hospices Civils de Lyon-Hopital Lyon Sud-1
  - Pontoise, France, 95300
    - Withdrawn
    - Hopital Novo
  - Périgueux, France, 24019
    - Withdrawn
    - Centre Hospitalier de Perigueux
  - Strasbourg, France, 67098
    - Withdrawn
    - Les Hopitaux Universitaires de Strasbourg-Hopital de Hautepierre-1
  - Venissieux, France, 69200
    - Withdrawn
    - Groupe Hospitalier Mutualiste Des Portes Du Sud
  - Villeurbanne, France, 69100
    - Withdrawn
    - RESEAU DE SANTE MUTUALISTE-Médipôle Hôpital Mutualiste
Germany
- - Essen, Germany, 45147
    - Withdrawn
    - Klinik für Endokrinologie, Diabetologie und Stoffwechsel
  - Essen, Germany, 45355
    - Withdrawn
    - Praxis am Markt Dr. Becker
  - Freiburg, Germany, 79106
    - Withdrawn
    - Universitätsklinikum Freiburg
  - Heidelberg, Germany, 69120
    - Withdrawn
    - Uniklinik Heidelberg Innere Medizin I
  - München, Germany, 81477
    - Withdrawn
    - Diabeteszentrum München Süd
  - München, Germany, 81667
    - Withdrawn
    - Medicover Neuroendokrinologie MVZ
  - Münster, Germany, 48145
    - Withdrawn
    - Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
  - Münster, Germany, 48153
    - Withdrawn
    - MedicalCenter am Clemenshospital
  - Osnabrück, Germany, 49080
    - Withdrawn
    - Institut für Diabetesforschung Osnabrück
  - Wangen, Germany, 88239
    - Withdrawn
    - Zentrum für klinische Studien Allgäu Oberschwaben
Greece
- - Athens, Greece, GR-11527
    - Withdrawn
    - "Laiko" General Hospital of Athens
  - Athens, Greece, GR-17562
    - Withdrawn
    - Iatriko Athinon 'Palaiou Falirou'
  - Haidari-Athens, Greece, GR-12462
    - Withdrawn
    - University Hospital of Athens ATTIKON
  - Thessaloniki, Greece, GR-57001
    - Withdrawn
    - "Thermi" Private Hosital
Hungary
- - Budapest, Hungary, 1036
    - Withdrawn
    - Óbudai Egészségügyi Centrum
  - Budapest, Hungary, 1134
    - Withdrawn
    - MH Egészségügyi Központ
  - Kaposvár, Hungary, 7400
    - Withdrawn
    - Kaposi Mór Oktató Kórház
  - Zalaegerszeg, Hungary, 8900
    - Withdrawn
    - Zala Megyei Szent Rafael Korhaz
India
- - Aligarh, India, 202002
    - Not yet recruiting
    - Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University
  - Chennai, India, 603203
    - Not yet recruiting
    - SRM Centre for Clinical Trials & Research
  - Surat, India, 395002
    - Not yet recruiting
    - Nirmal Hospital Pvt. Ltd.
  - Thriruvananthapuram, India, 695 032
    - Not yet recruiting
    - Jothydev's Diabetes & Research Center
- Gujarat
  - Vadodara, Gujarat, India, 390006
    - Not yet recruiting
    - SSG Hospital, Baroda
- Karnataka
  - Belgaum, Karnataka, India, 590001
    - Not yet recruiting
    - Belgaum Diabetes Centre
- Kerala
  - Kozhikode, Kerala, India, 673008
    - Not yet recruiting
    - Government Medical College, Kozhikode
- Kerela
  - Thiruvnanthapuram, Kerela, India, 695033
    - Not yet recruiting
    - Indian Institute of Diabetes
- Maharashtra
  - Mumbai, Maharashtra, India, 400058
    - Not yet recruiting
    - BSES MG hospital
  - Mumbai, Maharashtra, India, 400012
    - Not yet recruiting
    - Seth GS Medical College & KEM Hospital
  - Pune, Maharashtra, India, 411001
    - Not yet recruiting
    - Grant Medical Foundation Ruby Hall Clinic
  - Pune, Maharashtra, India, 411021
    - Not yet recruiting
    - Chellaram Diabetes Institute
- New Delhi
  - Delhi, New Delhi, India, 110002
    - Not yet recruiting
    - Maulana Azad Medical College
- Rajasthan
  - Jaipur, Rajasthan, India, 302004
    - Not yet recruiting
    - SMS Medical College & Hospital
  - Jaipur, Rajasthan, India, 302006
    - Not yet recruiting
    - Diabetes, Thyroid and Endocrine Centre
- Tamil Nadu
  - Vellore, Tamil Nadu, India, 632004
    - Not yet recruiting
    - Christian Medical College Hospital, Vellore
- Telangana
  - Hyderabad, Telangana, India, 500032
    - Not yet recruiting
    - AIG Hospitals,Hyderabad
- Uttar Pradesh
  - Noida, Uttar Pradesh, India, 201310
    - Not yet recruiting
    - Government Institute of Medical Sciences
- West Bengal
  - Kolkata,, West Bengal, India, 700053
    - Not yet recruiting
    - BP Poddar Hospital
Poland
- - Bialystok, Poland, 15-351
    - Withdrawn
    - Osteo-Medic s.c. A. Racewicz, J. Supronik
  - Lodz, Poland, 90-132
    - Withdrawn
    - Gabinet Lekarski Malgorzata Saryusz-Wolska
  - Lodz, Poland, 90-338
    - Withdrawn
    - Centrum Terapii Wspolczesnej
  - Zabrze, Poland, 41-800
    - Withdrawn
    - Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Szyszko
- Lubuskie
  - Gorzow Wielkopolski, Lubuskie, Poland, 66-400
    - Withdrawn
    - Specjalistyczny Gabinet Diabetologiczny Radoslaw Rumianowski
- Malopolskie
  - Rzeszow, Malopolskie, Poland, 35-055
    - Withdrawn
    - Centrum Medyczne Medyk Sp. z o.o.
- Mazowieckie
  - Warszawa, Mazowieckie, Poland, 00-710
    - Withdrawn
    - NBR Polska
- Podlaskie Voivodeship
  - Bialystok, Podlaskie Voivodeship, Poland, 15-276
    - Withdrawn
    - Uniwersytecki Szpital Kliniczny w Bialymstoku
Romania
- - Bacau, Romania, 600238
    - Withdrawn
    - Minimed S.R.L.
  - Brasov, Romania, 500101
    - Withdrawn
    - Mariodiab Clinic SRL
  - Bucuresti, Romania, 011053
    - Withdrawn
    - Hightech Medical Services S.R.L.
  - Iasi, Romania, 700547
    - Withdrawn
    - SC Consultmed SRL
  - Timisoara, Romania, 300723
    - Withdrawn
    - Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara
- Bihor
  - Oradea, Bihor, Romania, 410147
    - Withdrawn
    - Diabdana S.R.L.
- Bucurestii
  - Bucharest, Bucurestii, Romania, 020475
    - Withdrawn
    - Institutul National De Diabet Nutritie Si Boli Metabolice Prof.Dr.N.Paulescu Bucuresti- Ion Movila
- Cluj
  - Cluj Napoca, Cluj, Romania, 400006
    - Withdrawn
    - Spitalul Clinic Judetean Urgenta Cluj-Napoca
South Africa
- Gauteng
  - Boksburg, Gauteng, South Africa, 1466
    - Not yet recruiting
    - Dr Wilhase's rooms
  - Johannesburg, Gauteng, South Africa, 1827
    - Not yet recruiting
    - Ubuntu Clinical Research
  - Krugersdorp, Gauteng, South Africa, 1739
    - Not yet recruiting
    - Krugersdorp Medical Centre
- KwaZulu-Natal
  - Durban, KwaZulu-Natal, South Africa, 4001
    - Not yet recruiting
    - Synapta Clinical Research Centre
  - Durban, KwaZulu-Natal, South Africa, 4450
    - Not yet recruiting
    - Dr J Reddy
- Western Cape
  - Cape Town, Western Cape, South Africa, 7560
    - Not yet recruiting
    - Bella Vita Clinical Research
Spain
- - Santa Cruz de Tenerife, Spain, 38320
    - Withdrawn
    - Hospital Universitario de Canarias
  - Sevilla, Spain, 41013
    - Withdrawn
    - Hospital Universitario Virgen del Rocío
  - Toledo, Spain, 45007
    - Withdrawn
    - Hospital General Universitario de Toledo
  - Valladolid, Spain, 47003
    - Withdrawn
    - Hospital Clínico Universitario de Valladolid
- Almería
  - Almeria, Almería, Spain, 04009
    - Withdrawn
    - Centro Periferico De Especialidades Bola Azul
- Madrid
  - Alcorcón, Madrid, Spain, 28922
    - Withdrawn
    - Hospital Fundación Alcorcón
Taiwan
- - Kaohsiung City, Taiwan, 807
    - Recruiting
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Taichung City, Taiwan, 402
    - Recruiting
    - Chung Shan Medical University Hospital
  - Taichung City, Taiwan, 407
    - Not yet recruiting
    - Taichung Veterans General Hospital
  - Taichung City, Taiwan, 433
    - Recruiting
    - Kuang Tien General Hospital
  - Tainan City, Taiwan, 704
    - Recruiting
    - National Cheng Kung University Hospital
  - Taipei, Taiwan, 100
    - Recruiting
    - National Taiwan University Hospital
  - Taipei, Taiwan, 112
    - Recruiting
    - Taipei Veterans General Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35211
    - Not yet recruiting
    - Synexus Clin Res-Birmingham
  - Birmingham, Alabama, United States, 35233
    - Recruiting
    - Univ of Alabama_Birmingham
- Arizona
  - Gilbert, Arizona, United States, 85296
    - Recruiting
    - Prime Medical Group, LLC
  - 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
    - Not yet recruiting
    - Arkansas Clinical Research
  - Searcy, Arkansas, United States, 72143
    - Recruiting
    - Unity Health-Searcy Medical Center
- California
  - Chula Vista, California, United States, 91911
    - Not yet recruiting
    - Velocity Clin Res-Chula Vista
  - Escondido, California, United States, 92025
    - Recruiting
    - Neighborhood Healthcare
  - Escondido, California, United States, 92025
    - Recruiting
    - Headlands Research California, LLC
  - Fullerton, California, United States, 92835
    - Not yet recruiting
    - St. Jude Heritage Yorba Linda - Pediatric Ste D
  - La Mesa, California, United States, 91942
    - Recruiting
    - Velocity Clin Res San Diego
  - La Mesa, California, United States, 91942
    - Not yet recruiting
    - Diabetes and Endocrine Specialists - La Mesa
  - La Mesa, California, United States, 91942
    - Recruiting
    - Diabetes & Endocrine Specialists - La Mesa
  - Lincoln, California, United States, 95648
    - Recruiting
    - Clinical Trials Research
  - Loma Linda, California, United States, 92354
    - Recruiting
    - Loma Linda Univ Hlth Cr Endo
  - Northridge, California, United States, 91325
    - Recruiting
    - Valley Clinical Trials, Inc.
  - Palm Springs, California, United States, 92262
    - Recruiting
    - Desert Oasis Healthcare
  - Panorama City, California, United States, 91402
    - Recruiting
    - Velocity Clin Res - Panorama
  - Panorama City, California, United States, 91402
    - Not yet recruiting
    - Velocity Clin Res - Panorama
  - Pomona, California, United States, 91766
    - Recruiting
    - Western University of Health Sciences
  - San Jose, California, United States, 95148
    - Not yet recruiting
    - Endocrinology Josel Cabaccan
  - San Mateo, California, United States, 94401
    - Not yet recruiting
    - Mills-Peninsula Medical Center
  - San Mateo, California, United States, 94401
    - Recruiting
    - Mills-Peninsula Medical Center
  - San Ramon, California, United States, 94583
    - Recruiting
    - NorCal Endocrinology and Internal Medicine
  - Toluca Lake, California, United States, 91602
    - Recruiting
    - Premier Medical Center, Inc.
  - Walnut Creek, California, United States, 94598
    - Recruiting
    - Diablo Clinical Research, Inc.
- Colorado
  - Aurora, Colorado, United States, 80045
    - Recruiting
    - University of Colorado Hospital
  - Colorado Springs, Colorado, United States, 80906
    - Recruiting
    - Optumcare Colorado Springs
- Florida
  - Jacksonville, Florida, United States, 32204
    - Recruiting
    - Northeast Res Inst. Inc.
  - Miami, Florida, United States, 33165
    - Recruiting
    - New Horizon Research Center
  - Miami, Florida, United States, 33165
    - Not yet recruiting
    - New Horizon Research Center
  - Miramar, Florida, United States, 33027
    - Recruiting
    - South Broward Research LLC
  - Ocoee, Florida, United States, 34761
    - Not yet recruiting
    - West Orange Endocrinology
  - Orange City, Florida, United States, 32763
    - Recruiting
    - Optimal Research Sites
  - Orlando, Florida, United States, 32804
    - Not yet recruiting
    - Trans Res Inst for Met & Diab
  - Oviedo, Florida, United States, 32765
    - Recruiting
    - Oviedo Medical Research, LLC
- Georgia
  - Conyers, Georgia, United States, 30094
    - Recruiting
    - Hope Clin Res & Wellness
  - Gainesville, Georgia, United States, 30501
    - Not yet recruiting
    - Center for Adv Res & Education
  - Marietta, Georgia, United States, 30067
    - Recruiting
    - Urban Family Practice Assoc
  - Roswell, Georgia, United States, 30076
    - Recruiting
    - Endocrine Research Solutions
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - Not yet recruiting
    - 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
- Indiana
  - Greenfield, Indiana, United States, 46140
    - Withdrawn
    - American Health Network of Indiana, LLC_Greenfield
- Iowa
  - West Des Moines, Iowa, United States, 50265
    - Recruiting
    - Iowa Diabetes & Endo Res Ctr
- Kansas
  - Topeka, Kansas, United States, 66606
    - Recruiting
    - Cotton-O'Neil Diab & Endo Ctr
- Louisiana
  - Lafayette, Louisiana, United States, 70508
    - Not yet recruiting
    - Velocity Clin Res Lafayette
- Maryland
  - Hyattsville, Maryland, United States, 20782
    - Recruiting
    - MedStar Hlth Res Institute
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Not yet recruiting
    - Joslin Center For Diabetes
- Minnesota
  - Minneapolis, Minnesota, United States, 55416
    - Recruiting
    - International Diabetes Center
- Mississippi
  - Belzoni, Mississippi, United States, 39038
    - Recruiting
    - Belzoni Clinical Research
  - Belzoni, Mississippi, United States, 39038
    - Not yet recruiting
    - Belzoni Clinical Research
  - Gulfport, Mississippi, United States, 39503
    - Recruiting
    - Velocity Clin Res Gulfport
- Missouri
  - Chesterfield, Missouri, United States, 63017
    - Recruiting
    - Diabetes & Endo Specialists Inc
  - Saint Louis, Missouri, United States, 63128
    - Recruiting
    - Amicis Centers of Clinical Research
  - Saint Peters, Missouri, United States, 63303
    - Recruiting
    - StudyMetrix Research LLC
- 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
    - Not yet recruiting
    - Velocity Clin Res Syracuse
  - West Seneca, New York, United States, 14224
    - Recruiting
    - Southgate Medical Group, LLP
- North Carolina
  - Chapel Hill, North Carolina, United States, 27514
    - Recruiting
    - UNC Eastowne Clinical Research Unit
  - Greensboro, North Carolina, United States, 27408
    - Recruiting
    - PharmQuest Life Sciences LLC
  - Morehead City, North Carolina, United States, 28557
    - Recruiting
    - Carteret Medical Group
  - Morehead City, North Carolina, United States, 28557
    - Recruiting
    - Lucas Research Inc.
  - Statesville, North Carolina, United States, 28625
    - Recruiting
    - Piedmont Healthcare/Research
  - Wilmington, North Carolina, United States, 28401
    - Recruiting
    - Accellacare
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Recruiting
    - Plains Clinical Research Center, LLC
- Ohio
  - Columbus, Ohio, United States, 43215
    - Recruiting
    - Remington Davis Inc
  - Maumee, Ohio, United States, 43537
    - Recruiting
    - Advanced Medical Research
  - Wadsworth, Ohio, United States, 44281-9236
    - Not yet recruiting
    - New Venture Medical Research
  - Wadsworth, Ohio, United States, 44281-9236
    - Recruiting
    - New Venture Medical Research
- Oklahoma
  - Norman, Oklahoma, United States, 73072
    - Not yet recruiting
    - Lynn Institute of Norman
- Pennsylvania
  - Hatboro, Pennsylvania, United States, 19040
    - Recruiting
    - CCT Research
  - Philadelphia, Pennsylvania, United States, 19114
    - Recruiting
    - Thomas Jefferson University_Philadelphia
- 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
    - Velocity Clinical Res-Anderson
  - Myrtle Beach, South Carolina, United States, 29572
    - Recruiting
    - Trial Management Associates
  - 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
    - Not yet recruiting
    - Spartanburg Medical Research
- Tennessee
  - Bartlett, Tennessee, United States, 38133
    - Not yet recruiting
    - AM Diabetes And Endocrinology Center
  - Bristol, Tennessee, United States, 37620-7352
    - Recruiting
    - Holston Medical Group Pc
  - Chattanooga, Tennessee, United States, 37411
    - Recruiting
    - Univ Diab & Endo Consultants
  - Jackson, Tennessee, United States, 38305
    - Recruiting
    - Jackson Clinic
  - Kingsport, Tennessee, United States, 37660
    - Recruiting
    - Holston Medical Group
  - Memphis, Tennessee, United States, 38119
    - Not yet recruiting
    - Clinical Neuroscience Solutions
  - Morristown, Tennessee, United States, 37813
    - Recruiting
    - HealthStar Physicians PC
  - Nashville, Tennessee, United States, 37203
    - Recruiting
    - Clinical Research Associates
  - Nashville, Tennessee, United States, 37203
    - Not yet recruiting
    - Clinical Research Associates
- Texas
  - Arlington, Texas, United States, 76012-4637
    - Recruiting
    - Arlington Family Res. Ctr Inc
  - Austin, Texas, United States, 78759
    - Not yet recruiting
    - Velocity Clin Res
  - 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, 75231
    - Not yet recruiting
    - North Texas Endocrine Center
  - Dallas, Texas, United States, 75234
    - Not yet recruiting
    - Synexus Clin Res Dallas
  - Dallas, Texas, United States, 75230
    - Recruiting
    - Velocity Clin Res, Dallas
  - Houston, Texas, United States, 77024
    - Recruiting
    - PrimeCare Medical Group
  - Houston, Texas, United States, 77079
    - Recruiting
    - PlanIt Research, PLLC
  - Houston, Texas, United States, 77061
    - Recruiting
    - Discovery MM Services, Inc
  - Houston, Texas, United States, 77089
    - Not yet recruiting
    - Amir Ali Hassan, MD, PA
  - Houston, Texas, United States, 77074
    - Recruiting
    - Juno Research, LLC_Houston
  - Lampasas, Texas, United States, 76550
    - Recruiting
    - Fmc Science, Llc
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - University of Texas San Antonio
  - San Antonio, Texas, United States, 78233
    - Recruiting
    - NE Clin Res of San Antonio
  - San Antonio, Texas, United States, 78209
    - Recruiting
    - Quality Clinical Research, Inc.
  - Shavano Park, Texas, United States, 78231
    - Recruiting
    - Consano Clinical Research, LLC
  - Sugar Land, Texas, United States, 77479
    - Recruiting
    - Mt Olympus Medical Research, LLC
  - Tomball, Texas, United States, 77375
    - Recruiting
    - DM Clin Rsrch/Fam Diag Clinic
- Utah
  - Salt Lake City, Utah, United States, 84121
    - Recruiting
    - Foothill Family Clinic South
  - South Jordan, Utah, United States, 84095
    - Recruiting
    - J.Lewis Research Inc
  - 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
    - Prevea Health

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Male or female.
Age 18 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes ≥ 180 days before screening.
Stable daily dose(s) ≥ 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 an sodium-glucose co-transporter-2 (SGLT2) inhibitor.
HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive) as determined by central laboratory at screening.
Body mass index (BMI) of ≥ 30.0 kilogram per square meter (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:

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
Renal impairment with estimated Glomerular Filtration Rate < 30 milliliter per minute per 1.73 square meter (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. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

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: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CagriSema Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.	Drug: Cagrilintide Cagrilintide will be administered subcutaneously. Drug: Semaglutide Semaglutide will be administered subcutaneously.
Active Comparator: Tirzepatide Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.	Drug: Tirzepatide Tirzepatide 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 baseline (week 0) to end of treatment (week 68)	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 68)
Change in glycated haemoglobin (HbA1c) Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in percentage (%)-points.	From baseline (week 0) to end of treatment (week 68)

Secondary Outcome Measures

Collaborators and Investigators

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

Sponsor

Novo Nordisk A/S

Investigators

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

Study record dates

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

Study Major Dates

Study Start (Actual)

January 16, 2024

Primary Completion (Estimated)

November 11, 2025

Study Completion (Estimated)

December 23, 2025

Study Registration Dates

First Submitted

January 15, 2024

First Submitted That Met QC Criteria

January 15, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

NN9388-4894
U1111-1282-5561 (Other Identifier: World Health Organization (WHO))
2023-503789-21-00 (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

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

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Outcome Measure	Measure Description	Time Frame
Change in waist circumference Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 68)
Change in HbA1c Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in %-points.	From baseline (week 0) to end of treatment (week 68)
Change in fasting plasma glucose (FPG) Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in millimoles per liter (mmol/L).	From baseline (week 0) to end of treatment (week 68)
Achievement of HbA1c target values of less than (<) 7.0% (<53 millimole per mole [mmol/mol]) Time Frame: At end of treatment (week 68)	Count of participant	At end of treatment (week 68)
Achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤ 48 mmol/mol) Time Frame: From baseline (week 0) to end of treatment (week 68)	Count of participant	From baseline (week 0) to end of treatment (week 68)
Achievement of greater than or equal to (≥) 5% weight reduction Time Frame: From baseline (week 0) to end of treatment (week 68)	Count of participant	From baseline (week 0) to end of treatment (week 68)
Achievement of ≥ 10% weight reduction Time Frame: From baseline (week 0) to end of treatment (week 68)	Count of participant	From baseline (week 0) to end of treatment (week 68)
Achievement of ≥ 15 % weight reduction Time Frame: From baseline (week 0) to end of treatment (week 68)	Count of participant	From baseline (week 0) to end of treatment (week 68)
Achievement of ≥ 20 % weight reduction Time Frame: From baseline (week 0) to end of treatment (week 68)	Count of participant	From baseline (week 0) to end of treatment (week 68)
Change in systolic blood pressure 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)
Change in diastolic blood pressure 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)
Ratio to baseline in lipids: Total cholesterol Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Triglycerides Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: non-HDL cholesterol Time Frame: From baseline (week 0) to end of treatment (week 68)	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey Time Frame: From baseline (week 0) to end of treatment (week 68)	The SF-36 v2 will be used to measure differences in quality of life and mental wellbeing. The scores 0-100 (where higher scores indicated a better quality of life and mental wellbeing) from the SF-36 will be converted to a norm-based score using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 1998 United States general population. Measured as score on a scale.	From baseline (week 0) to end of treatment (week 68)
Change in Impact of Weight on Quality of Life-Lite Clinical Trials (IWQOL-Lite-CT) version 3 Time Frame: From baseline (week 0) to end of treatment (week 68)	IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. Composite scores (score range): Physical composite (0-100), Psychosocial composite (0-100), Physical Function composite (0-100). Total score (0-100). Higher scores indicate better level of functioning.	From baseline (week 0) to end of treatment (week 68)
Number of Treatment-emergent Adverse Events (TEAEs) Time Frame: From baseline (week 0) to end of study (week 74)	Count of events	From baseline (week 0) to end of study (week 74)
Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (<54 milligram per deciliter [mg/dL]), confirmed by blood glucose meter) Time Frame: From baseline (week 0) to end of study (week 74)	Count of episodes	From baseline (week 0) to end of study (week 74)
Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold Time Frame: From baseline (week 0) to end of study (week 74)	Count of episodes	From baseline (week 0) to end of study (week 74)

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Type 2 Diabetes

Clinical Trials on Cagrilintide

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations