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A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
Sponsor: Novo Nordisk A/S
Summary
This study will look at how well CagriSema helps people living with obesity to lose weight and maintain the weight loss long-term. The study has 2 parts: The first part is called 'the main study' and the second part is called 'the extension study'. In the main study participants will either get CagriSema (a study medicine) or placebo (a dummy medicine that looks like CagriSema but has no active ingredient). Which treatment participants get is decided by chance. Participants are two times more likely to get CagriSema than placebo. If participants get CagriSema in the main study, participants will continue on CagriSema in the extension study. Which dose of CagriSema participants will continue on is decided by chance. If participants get placebo in the main study, participants will get CagriSema in the extension study. Participants will take one injection of study medicine once a week. The study will last for about 3 years and 3 months.
Official title: Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c. (CagriSema s.c.) Once Weekly for Weight Management and Long-term Weight Maintenance in Participants With Obesity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
609
Start Date
2025-06-03
Completion Date
2028-10-17
Last Updated
2025-12-12
Healthy Volunteers
No
Conditions
Interventions
CagriSema (Cagrilintide B and Semaglutide I)
CagriSema (Cagrilintide B and Semaglutide I) will be administered subcutaneously using DV3384 pen-injector.
Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)
Placebo matched to Cagrilintide B and placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
Locations (46)
FDRC
Costa Mesa, California, United States
Linda Vista Health Care Ctr
San Diego, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Northeast Research Institute
Fleming Island, Florida, United States
Jacksonville Ctr For Clin Res
Jacksonville, Florida, United States
South Broward Research LLC
Miramar, Florida, United States
Florida Inst For Clin Res LLC
Orlando, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Cnt for Diab,Obes, and Metab
Pembroke Pines, Florida, United States
Hope Clin Res & Wellness
Conyers, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Endeavor Health
Skokie, Illinois, United States
Evanston Premier Hlthcr Res
Skokie, Illinois, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
Iowa Diab & Endo Res Center
West Des Moines, Iowa, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
Amicis Centers of Clinical Research
St Louis, Missouri, United States
Mercury Str Med Grp, PLLC
Butte, Montana, United States
Southgate Medical Group, LLP
West Seneca, New York, United States
Great Lakes Medical Research
Westfield, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Accellacare_NC
Raleigh, North Carolina, United States
Piedmont Healthcare/Research
Statesville, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
New Venture Medical Research
Wadsworth, Ohio, United States
Lynn Institute of Norman
Norman, Oklahoma, United States
Clinical Res Collaborative
Cumberland, Rhode Island, United States
Coastal Carolina Res Ctr
North Charleston, South Carolina, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Clinical Research Associates
Nashville, Tennessee, United States
Amarillo Medical Specialists
Amarillo, Texas, United States
Velocity Clin Res, Dallas
Dallas, Texas, United States
PlanIt Research, PLLC
Houston, Texas, United States
Radiance Clinical Research
Lampasas, Texas, United States
DCOL Ctr for Clin Res
Longview, Texas, United States
Northeast Clinical Research of San Antonio
Schertz, Texas, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, United States
Health Res of Hampton Roads
Newport News, Virginia, United States
Selma Medical Associates
Winchester, Virginia, United States
Rainier Clin Res Ctr Inc
Renton, Washington, United States