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
NCT ID: NCT06221969
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2024-01-16
2026-04-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Cagrilintide
Cagrilintide will be administered subcutaneously.
Semaglutide
Semaglutide will be administered subcutaneously.
Tirzepatide
Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.
Tirzepatide
Tirzepatide will be administered subcutaneously.
Interventions
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Cagrilintide
Cagrilintide will be administered subcutaneously.
Semaglutide
Semaglutide will be administered subcutaneously.
Tirzepatide
Tirzepatide will be administered subcutaneously.
Eligibility Criteria
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Inclusion Criteria
* 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.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Synexus Clin Res-Birmingham
Birmingham, Alabama, United States
Univ of Alabama_Birmingham
Birmingham, Alabama, United States
Prime Medical Group, LLC
Gilbert, Arizona, United States
Velocity Clinical Research-Phoenix
Phoenix, Arizona, United States
Synexus Rsch /Cnt Phnx Med C
Phoenix, Arizona, United States
Arkansas Clinical Research
Little Rock, Arkansas, United States
Unity Health-Searcy Medical Center
Searcy, Arkansas, United States
Velocity Clin Res-Chula Vista
Chula Vista, California, United States
Headlands Research California, LLC
Escondido, California, United States
Neighborhood Healthcare
Escondido, California, United States
St. Jude Heritage Yorba Linda - Pediatric Ste D
Fullerton, California, United States
Diabetes & Endocrine Specialists - La Mesa
La Mesa, California, United States
Diabetes and Endocrine Specialists - La Mesa
La Mesa, California, United States
Velocity Clin Res San Diego
La Mesa, California, United States
Clinical Trials Research
Lincoln, California, United States
Loma Linda Univ Hlth Cr Endo
Loma Linda, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Desert Oasis Healthcare
Palm Springs, California, United States
Velocity Clin Res - Panorama
Panorama City, California, United States
Western University of Health Sciences
Pomona, California, United States
Endocrinology Josel Cabaccan
San Jose, California, United States
Mills-Peninsula Medical Center
San Mateo, California, United States
NorCal Endocrinology and Internal Medicine
San Ramon, California, United States
Premier Medical Center, Inc.
Toluca Lake, California, United States
Velocity Clin Res - Panorama
Van Nuys, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Optumcare Clinical Trials,LLC-Golden
Colorado Springs, Colorado, United States
Northeast Res Inst. Inc.
Jacksonville, Florida, United States
Clinical Trial Services Corp
Miami, Florida, United States
Bioclinical Research Alliance
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
West Orange Endocrinology
Ocoee, Florida, United States
Optimal Research Sites
Orange City, Florida, United States
Trans Res Inst for Met & Diab
Orlando, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
Center for Adv Res & Education
Gainesville, Georgia, United States
Urban Family Practice Assoc
Marietta, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
Pacific Diabetes & Endo Ctr
Honolulu, Hawaii, United States
St. Luke's Health System
Boise, Idaho, United States
Solaris Clinical Research
Meridian, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Clinical Invest Special_Gurnee
Gurnee, Illinois, United States
Endeavor Health
Skokie, Illinois, United States
Evanston Premier Hlthcr Res
Skokie, Illinois, United States
American Health Network of Indiana, LLC_Greenfield
Greenfield, Indiana, United States
Iowa Diabetes & Endo Res Ctr
West Des Moines, Iowa, United States
Cotton-O'Neil Diab & Endo Ctr
Topeka, Kansas, United States
Velocity Clin Res Lafayette
Lafayette, Louisiana, United States
MedStar Hlth Res Institute
Hyattsville, Maryland, United States
Joslin Diabetes Center
Boston, Massachusetts, United States
International Diabetes Center
Minneapolis, Minnesota, United States
Belzoni Clinical Research
Belzoni, Mississippi, United States
Velocity Clin Res Gulfport
Gulfport, Mississippi, United States
Diabetes & Endo Specialists Inc
Chesterfield, Missouri, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
Amicis Centers of Clinical Research
St Louis, Missouri, United States
Velocity Clin Res Albuquerque
Albuquerque, New Mexico, United States
AMC Community Endocrinology
Albany, New York, United States
Velocity Clin Res Syracuse
East Syracuse, New York, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
UNC Eastowne Clinical Research Unit
Chapel Hill, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Carteret Medical Group
Morehead City, North Carolina, United States
Lucas Research Inc.
Morehead City, North Carolina, United States
Piedmont Healthcare/Research
Statesville, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Plains Clinical Research Center, LLC
Fargo, North Dakota, United States
Remington Davis Inc
Columbus, Ohio, United States
Advanced Medical Research
Maumee, Ohio, United States
New Venture Medical Research
Wadsworth, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
CCT Research
Horsham, Pennsylvania, United States
Thomas Jefferson University_Philadelphia
Philadelphia, Pennsylvania, United States
Clinical Res Collaborative
Cumberland, Rhode Island, United States
Velocity Clin Res Providence
East Greenwich, Rhode Island, United States
Velocity Clinical Res-Anderson
Anderson, South Carolina, United States
Trial Management Associates
Myrtle Beach, South Carolina, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
AM Diabetes And Endocrinology Center
Bartlett, Tennessee, United States
Holston Medical Group Pc
Bristol, Tennessee, United States
Univ Diab & Endo Consultants
Chattanooga, Tennessee, United States
Jackson Clinic
Jackson, Tennessee, United States
Holston Medical Group
Kingsport, Tennessee, United States
Clinical Neuroscience Solutions
Memphis, Tennessee, United States
HealthStar Physicians PC
Morristown, Tennessee, United States
Clinical Research Associates
Nashville, Tennessee, United States
Arlington Family Res. Ctr Inc
Arlington, Texas, United States
Velocity Clin Res
Austin, Texas, United States
UT Health University of Texas
Bellaire, Texas, United States
Velocity Clin Res, Dallas
Dallas, Texas, United States
North Texas Endocrine Center
Dallas, Texas, United States
Synexus Clin Res Dallas
Dallas, Texas, United States
Cedar Health Research
Dallas, Texas, United States
PrimeCare Medical Group
Houston, Texas, United States
JCCT- Juno NW Houston
Houston, Texas, United States
Discovery MM Services, Inc
Houston, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Amir Ali Hassan, MD, PA
Houston, Texas, United States
Fmc Science, Llc
Lampasas, Texas, United States
Quality Clinical Research, Inc.
San Antonio, Texas, United States
University of Texas San Antonio
San Antonio, Texas, United States
NE Clin Res of San Antonio
San Antonio, Texas, United States
University of Texas San Antonio
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Mt Olympus Medical Research, LLC
Sugar Land, Texas, United States
DM Clin Rsrch/Fam Diag Clinic
Tomball, Texas, United States
Foothill Family Clinic South
Salt Lake City, Utah, United States
J.Lewis Research Inc
South Jordan, Utah, United States
Velocity Clin Res-Salt Lk City
West Jordan, Utah, United States
TPMG Clinical Research
Newport News, Virginia, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States
Prevea Health
Green Bay, Wisconsin, United States
Buenos Aires Mácula
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
CICEMO- Consultorio de Investigación Clínica EMO
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Medico Especializado_Capital Federal
Ciudad de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Metabolicas (IDIM)
Buenos Aires, , Argentina
OMI- Organización Médica de Investigación
Buenos Aires, , Argentina
CICEMO- Consultorio de Investigación Clínica EMO
Buenos Aires, , Argentina
CEDIC Centro de Investigación Clínica
CABA, , Argentina
Centro de Investigación Clínica
CABA, , Argentina
Instituto de Investigaciones Clinicas Mar Del Plata
Mar del Plata, , Argentina
CEDIR - Centro de diagnóstico y rehabilitación Santa Fe
Santa Fe, , Argentina
Paratus Clinical
Blacktown, New South Wales, Australia
Paratus Clinical
Kanwal, New South Wales, Australia
Hunter Diabetes Centre
Merewether, New South Wales, Australia
Royal North Shore Hospital
St Leonards, New South Wales, Australia
Townsville University Hospital
Douglas, Queensland, Australia
University of Sunshine Coast
Morayfield, Queensland, Australia
Momentum Clinical Research
Taringa, Queensland, Australia
Southern Adelaide Diabetes & Endocrine Services
Oaklands Park, South Australia, Australia
The Royal Melbourne Hospital
Parkville, Victoria, Australia
Austrials
St Albans, Victoria, Australia
Momentum Clinical Research
St Albans, Victoria, Australia
Centricity Research Calgary Endocrinology
Calgary, Alberta, Canada
Guilford Med Clinic
Surrey, British Columbia, Canada
TLC Diabetes and Endocrinology
Surrey, British Columbia, Canada
Ocean West Research Clinic
Surrey, British Columbia, Canada
Hilltop Medical Clinic
Surrey, British Columbia, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, Canada
Milestone Research
London, Ontario, Canada
Western Univ. Cnt for Studies in Fam Med
London, Ontario, Canada
London Road Diagnostic Clinic and Medical Centre
Sarnia, Ontario, Canada
Centricity Research Toronto
Toronto, Ontario, Canada
Diabetes Heart Research Centre
Toronto, Ontario, Canada
Centre Medical Acadie
Montreal, Quebec, Canada
ALPHA Recherche Clinique
Québec, Quebec, Canada
Ctr de Med Metab de Lanaudiere
Terrebonne, Quebec, Canada
Diex Recherche Victoriaville
Victoriaville, Quebec, Canada
Centricity Research Oshawa
Barrie, West Oshawa, Canada
Clin des Mal Lipid de Quebec
Québec, , Canada
Centre de Recherche Saint-Louis
Québec, , Canada
Clinica de la Costa
Barranquilla, Atlántico, Colombia
FOSCAL
Floridablanca, Santander Department, Colombia
Cimedical
Barranquilla, , Colombia
Centro de Investigación en Reumatología y Especialidades Médicas S.A.S. CIREEM S.A.S.
Bogotá, , Colombia
UNIENDO
Bogotá, , Colombia
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, India
SSG Hospital, Baroda
Vadodara, Gujarat, India
Belgaum Diabetes Centre
Belagavi, Karnataka, India
Government Medical College, Kozhikode
Kozhikode, Kerala, India
Indian Institute of Diabetes
Thiruvnanthapuram, Kerala, India
Seth GS Medical College & KEM Hospital
Mumbai, Maharashtra, India
BSES MG hospital
Mumbai, Maharashtra, India
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, India
Chellaram Diabetes Institute
Pune, Maharashtra, India
Maulana Azad Medical College
Delhi, New Delhi, India
SMS Medical College & Hospital
Jaipur, Rajasthan, India
Diabetes, Thyroid and Endocrine Centre
Jaipur, Rajasthan, India
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, India
AIG Hospitals,Hyderabad
Hyderabad, Telangana, India
Government Institute of Medical Sciences
Noida, Uttar Pradesh, India
BP Poddar Hospital
Kolkata, West Bengal, India
Rajiv Gandhi Centre for Diabetes and Endocrinology, J.N Medical College, Aligarh Muslim University
Aligarh, , India
SRM Centre for Clinical Trials & Research
Chennai, , India
Nirmal Hospital Pvt. Ltd.
Surat, , India
Jothydev's Diabetes & Research Center
Thriruvananthapuram, , India
Dr Wilhase's rooms
Boksburg, Gauteng, South Africa
Ubuntu Clinical Research
Johannesburg, Gauteng, South Africa
Krugersdorp Medical Centre
Krugersdorp, Gauteng, South Africa
Synapta Clinical Research Centre
Durban, KwaZulu-Natal, South Africa
Dr J Reddy
Durban, KwaZulu-Natal, South Africa
Bella Vita Clinical Research
Cape Town, Western Cape, South Africa
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Kuang Tien General Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan, , Taiwan
National Taiwan University Hospital_main
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Countries
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Other Identifiers
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U1111-1282-5561
Identifier Type: OTHER
Identifier Source: secondary_id
2023-503789-21-00
Identifier Type: OTHER
Identifier Source: secondary_id
NN9388-4894
Identifier Type: -
Identifier Source: org_study_id