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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
Sponsor: Novo Nordisk A/S
Summary
The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).
Official title: Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2734
Start Date
2023-09-27
Completion Date
2026-01-06
Last Updated
2026-07-08
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Locations (405)
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Gardena, California, United States
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Northeast Research Institute
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Clinical Trial Services Corp
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Bioclinical Research Alliance
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South Broward Research LLC
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West Orange Endocrinology
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AdventHealth Diab Inst
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Synexus Clin Res - Orlando
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Oviedo Medical Research, LLC
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Cedar-Crosse Research Center
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Evanston Premier Hlthcr Res
Skokie, Illinois, United States
Iowa Diabetes & Endo Res Ctr
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Alliance for Multispec Res
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Velocity Clin Res Lafayette
Lafayette, Louisiana, United States
BTC of New Bedford, LLC
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Velocity Clin Res Gulfport
Gulfport, Mississippi, United States
Diabetes & Endo Specialists Inc
Chesterfield, Missouri, United States
Premier Research Inc.
Trenton, New Jersey, United States
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Albuquerque, New Mexico, United States
AMC Community Endocrinology
Albany, New York, United States
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Southgate Medical Group, LLP
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University of North Carolina
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PharmQuest Life Sciences LLC
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Carteret Medical Group
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Piedmont Healthcare/Research
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Accellacare
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Synexus Clinical Research US, Inc
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Centricity Research
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Alliance for Multispec Res
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East Greenwich, Rhode Island, United States
AnMed Health IMA
Anderson, South Carolina, United States
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Anderson, South Carolina, United States
Velocity Clinical Res-Anderson
Anderson, South Carolina, United States
Velocity Clin Res Gaffney
Gaffney, South Carolina, United States
Hillcrest Clinical Research
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Spartanburg Medical Research
Spartanburg, South Carolina, United States
Velocity Clin Res Spartanburg
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Medical Colleagues-Texas LLP
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Discovery MM Services, INC Missouri
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University of Texas San Antonio
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Consano Clinical Research, LLC
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Rainier Clin Res Ctr Inc
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