Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
NCT ID: NCT07220642
Last Updated: 2025-12-23
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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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-11-05
2027-07-14
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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Cagrilintide
Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.
Cagrilintide
Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Placebo
Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.
Placebo
Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Interventions
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Cagrilintide
Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Placebo
Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Eligibility Criteria
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Inclusion Criteria
* Female or male (sex at birth)
* Age 18 years or above at the time of signing the informed consent
* History of at least one self-reported unsuccessful dietary effort to lose body weight (a\*)
* Body mass index (BMI) greater than or equal to \>= 30.0 kilogram per square meter (kg/m\^2), or BMI greater than or equal to \>= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a\*)
Exclusion Criteria
* Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (a\*)
* Previous dosing of marketed or non-marketed amylin-based compounds (a\*) (a\*) - As declared by the participant, reported in the medical records or at the investigator's discretion.
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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Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Univ of Colorado at Denver
Aurora, Colorado, United States
Florida Inst For Clin Res LLC
Orlando, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Walgreens - Store 11760
Oak Park, Illinois, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Selma Medical Associates
Winchester, Virginia, United States
CIPREC Pueyrredon
Buenos Aires, , Argentina
CEDIC Centro de Investigación Clínica
CABA, , Argentina
Sydney Cardiometabolic Centre
Liverpool, New South Wales, Australia
Hunter Diabetes Centre
Merewether, New South Wales, Australia
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
Hamilton Medical Rsrch Grp
Hamilton, Ontario, Canada
Wharton Med Clin Trials
Hamilton, Ontario, Canada
Milestone Research
London, Ontario, Canada
Centricity Research Oshawa
Oshawa, Ontario, Canada
Centricity Research Toronto
Toronto, Ontario, Canada
Centricity Research Mirabel
Mirabel, Quebec, Canada
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
Saint-Herblain, , France
Centre de Recherche Clinique Portes Du Sud
Vénissieux, , France
InnoDiab Forschung GmbH
Essen, , Germany
Wendisch/Dahl Hamburg (DZHW)
Hamburg, , Germany
RED-Institut für medizinische Forschung und Fortbildung GmbH
Oldenburg in Holstein, , Germany
Fondazione Policlinico Universitario Agostino Gemelli IRCS
Rome, RM, Italy
AOUP Giaccone Palermo
Palermo, Sicily, Italy
A.O.U. Bologna_ Policlinico S.Orsola Malpighi
Bologna, , Italy
IRCCS Ospedale San Raffaele Milano
Milan, , Italy
Haukeland Universitetssykehus
Bergen, , Norway
Drammen sykehus - Vestre Viken HF
Drammen, , Norway
St. Olavs Hospital HF
Trondheim, , Norway
Osteo-Medic s.c. A. Racewicz, J. Supronik
Bialystok, , Poland
Care Clinic Sp. z o. o.
Katowice, , Poland
Terpa Sp. z o.o. Sp. k.
Lublin, , Poland
NBR Polska Tomasz Klodawski
Warsaw, , Poland
Oak Tree Surgery
Liskeard, Cornwall, United Kingdom
North Coast Medical Ltd
Newquay, Cornwall, United Kingdom
Brunel Medical Practice
Torquay, Devon, United Kingdom
Countries
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Central Contacts
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Other Identifiers
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U1111-1314-8906
Identifier Type: OTHER
Identifier Source: secondary_id
2024-519530-24
Identifier Type: OTHER
Identifier Source: secondary_id
NN9833-8242
Identifier Type: -
Identifier Source: org_study_id