A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise
NCT ID: NCT06323174
Last Updated: 2026-01-14
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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COMPLETED
PHASE3
189 participants
INTERVENTIONAL
2024-03-19
2025-12-22
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
QUADRUPLE
Study Groups
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CagriSema Dose 2
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
Placebo Dose 2
Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 2 for 40 weeks.
Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Cagrisema Dose 1
Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 32 weeks.
Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
Placebo Dose 1
Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 for 40 weeks.
Placebo
Participants will receive placebo matched to cagrilintide and semaglutide subcutaneously.
Interventions
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Cagrilintide
Participants will receive once-weekly cagrilintide subcutaneously.
Semaglutide
Participants will receive once-weekly semaglutide subcutaneously.
Placebo
Participants will receive placebo matched to cagrilintide and semaglutide 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 \>=30 days before screening
* HbA1c 7.0-9.5 percent (53-80 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening
* Body mass index (BMI) \>=23 kilograms 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
* Renal impairment with estimated Glomerular Filtration Rate less than 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 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
* History of use of any injectable therapy for diabetes or obesity. 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
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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Nat Res Inst Huntington Park
Huntington Park, California, United States
Valley Clinical Trials, Inc.
Northridge, California, United States
Southern California Dermatology
Santa Ana, California, United States
Encore Medical Research LLC
Hollywood, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
Encore Medical Research of Weston
Weston, Florida, United States
Alliance for Multispec Res
Newton, Kansas, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Arcturus HC PLC Troy Med Res
Troy, Michigan, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
Summit Research Network Oregon Inc.
Portland, Oregon, United States
Holston Medical Group
Kingsport, Tennessee, United States
Amarillo Medical Specialists
Amarillo, Texas, United States
Elligo Clin Res Centre
Austin, Texas, United States
Headlands Research Brownsville
Brownsville, Texas, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
Northeast Clinical Research of San Antonio
San Antonio, Texas, United States
Consano Clinical Research, LLC
Shavano Park, Texas, United States
Sugar Lakes Family Practice PA
Sugar Land, Texas, United States
Valley Diab. & Endo Comp Ctr
Weslaco, Texas, United States
TPMG Clinical Research
Newport News, Virginia, United States
Chinese People's Liberation Army General Hospital-Endocrinology
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Nanjing Medical University-Endocrinology
Nanjing, Jiangsu, China
The Affiliated Hospital of Jiangsu University-Endocrinology
Zhenjiang, Jiangsu, China
Jinan Central Hospital
Ji'Nan, Shandong, China
Jinan Central Hospital
Jinan, Shandong, China
Belinus Bt.
Debrecen, Hajdú-Bihar, Hungary
Borbánya Praxis E.Ü. Kft.
Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary
Szent Margit Rendelőintézet Nonprofit Kft.
Budapest, , Hungary
PVN Kutato Kft.
Budapest, , Hungary
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, , Italy
Policlinico Mater Domini Università di Catanzaro
Catanzaro, , Italy
IRCCS Ospedale San Raffaele Milano
Milan, , Italy
Azienda Ospealiero Universitaria Policlinico Umberto I
Roma, , Italy
Centrum Medyczne Medyk Sp. z o.o.
Rzeszów, Podkarpackie Voivodeship, Poland
Osteo-Medic s.c. A. Racewicz, J. Supronik
Bialystok, , Poland
Renew Clinic Sp. z o.o.
Bialystok, , Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, , Poland
NBR Polska Tomasz Klodawski
Warsaw, , Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Warsaw, , Poland
Velocity Nova Sp. z o.o.
Zamość, , Poland
King Abdulaziz Hospital-Al Ahsa-National Guard
Al Ahsa, , Saudi Arabia
National Guard Hospital - Jeddah
Jeddah, , Saudi Arabia
King Fahad Medical City
Riyadh, , Saudi Arabia
King Khaled University Hospital,King Saud Univ. Med. City
Riyadh, , Saudi Arabia
King Salman Bin Abdulaziz Hospital
Riyadh, , Saudi Arabia
CHC Zvezdara, Clinical department for endocrinology
Belgrade, , Serbia
Clinical Hospital Center Bezanijska Kosa
Belgrade, , Serbia
Clinical Hospital Centre Zemun
Belgrade, , Serbia
Policlinic for diabetes
Zaječar, , Serbia
Countries
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Other Identifiers
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2022-502677-42
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1283-0404
Identifier Type: OTHER
Identifier Source: secondary_id
NN9388-4895
Identifier Type: -
Identifier Source: org_study_id
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