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A Research Study to Look Into the Long-term Effect on Weight Loss of CagriSema in People With Obesity
Sponsor: Novo Nordisk A/S
Summary
This study will look at how well CagriSema helps people with obesity lose weight compared to a "dummy medicine". CagriSema is a new medicine developed by Novo Nordisk. CagriSema cannot yet be prescribed by doctors. The study has two parts: First part is called the main phase and will last for 2 years, and second part is called the extension phase and will last for 1 year. In the main phase participants will either get CagriSema or "dummy medicine". Which treatment participants get is decided by chance and is not known by participants or the study doctor. In the extension phase participants will get either CagriSema or slowly reduce participants dose of CagriSema if participants had CagriSema in the main phase. Which treatment participants get is decided by chance and is not known by participants or the study doctor in both phases. If participants had "dummy medicine" in the main phase, participants will get CagriSema in the extension phase. Like all medicines, the study medicine may have side effects.
Official title: Long-term Efficacy and Safety of Cagrilintide s.c. 2.4 mg in Combination With Semaglutide s.c. 2.4 mg (CagriSema 2.4 mg/2.4 mg) Once Weekly Versus Placebo in Participants With Obesity
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2025-02-10
Completion Date
2028-10-31
Last Updated
2026-01-20
Healthy Volunteers
No
Conditions
Interventions
Cagrilintide
Participants will receive cagrilintide subcutaneously.
Semaglutide
Participants will receive semaglutide subcutaneously.
Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.
Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.
Locations (36)
Valley Clinical Trials
Covina, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
East West Medical Research Institute_Honolulu
Honolulu, Hawaii, United States
L-MARC Research Center
Louisville, Kentucky, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Holston Medical Group_Bristol
Bristol, Tennessee, United States
North Texas Endocrine Center
Dallas, Texas, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, United States
Cliniques Universitaires Saint-Luc - Serv Endocrinologie - Diabétologie
Brussels, Belgium
UZA - UZ Antwerpen - Department of Endocrinology
Edegem, Belgium
UZ Leuven - Endocrinology
Leuven, Belgium
CHU Helora - Hôpital de Mons - Site Constantinople
Mons, Belgium
Dr. M.B. Jones Inc
Victoria, British Columbia, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Premier Clinical Trial Research Network (PCTRN)
Hamilton, Ontario, Canada
Alpha Recherche Clinique - Lebourgneuf
Québec, Canada
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus, Denmark
Sydvestjysk Sygehus Esbjerg - Medicinsk Endokrinologisk Ambulatorium, Forskningsenheden
Esbjerg, Denmark
Gentofte Hospital - Center for Klinisk Metabolisk Forskning
Hellerup, Denmark
Hvidovre Hospital Endokrinologisk forsknings afsnit 159
Hvidovre, Denmark
Sjællands Universitetshospital, Køge - Medicinsk Afdeling
Køge, Denmark
ULS De Matosinhos E.P.E.- Hospital Pedro Hispano
Senhora Da Hora, Matosinhos, Matosinhos, Portugal
APDP - Associação Protectora dos Diabéticos de Portugal
Lisbon, Portugal
CUF Descobertas
Lisbon, Portugal
Hospital Cuf Descobertas S.A.
Lisbon, Portugal
Unidade Local de Saude de Sao Joao E.P.E
Porto, Portugal
Hospital Luz Arrabida, S.A.
Vila Nova de Gaia, Portugal
Southmead Hospital
Bristol, United Kingdom
Addenbrooke's Hospital_Cambridge
Cambridge, United Kingdom
University Hospital Coventry - WISDEM Centre
Coventry, United Kingdom
Aintree University Hospital
Liverpool, United Kingdom
Royal London Hospital - Blizard Institute
London, United Kingdom
Joint Clinical Research Facility - Swansea
Swansea, United Kingdom
Musgrove Park Hospital
Taunton, United Kingdom