Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
NCT ID: NCT07220759
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
330 participants
INTERVENTIONAL
2025-11-05
2027-07-28
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 (matched to Cagrilintide)
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 (matched to Cagrilintide)
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) \>= 27.0 kilogram per square meter (kg/m\^2).(a\*)
* Diagnosed with type 2 diabetes \>= 180 days before screening.
* Treatment with either lifestyle intervention(a\*), or:
* Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice.(a\*)
* For up to 30% of participants the following concomitant medication is allowed:
* Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening (a\*) and/or
* Treatment with basal insulin minimum (0.25 units per kilogram per day (U/kg/day) or 20 units per day \[U/day\]) stable for at least 90 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.
Exclusion Criteria
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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Univ of Alabama_Birmingham
Birmingham, Alabama, United States
Chambliss Clinical Trials, LLC
Montgomery, Alabama, United States
Elite Clinical Network - Tucson
Tucson, Arizona, United States
Scripps Whittier Diabetes Inst
La Jolla, California, United States
Clinical Trials Research
Lincoln, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Walgreens - Store 4442
Kissimmee, Florida, United States
Optimal Research Sites
Orange City, Florida, United States
Center for Diab,Obes & Metab
Pembroke Pines, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
East West Med Res Inst
Honolulu, Hawaii, United States
MediSphere Medical RC
Evansville, Indiana, United States
Walgreens - Store 3915
Las Vegas, Nevada, United States
Chear Center LLC
The Bronx, New York, United States
Centricity Res New Bern
New Bern, North Carolina, United States
Accellacare
Wilmington, North Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Holston Medical Group_Bristol
Bristol, Tennessee, United States
Velocity Clinical Res-Dallas
Dallas, Texas, United States
TPMG Clinical Research
Newport News, Virginia, United States
National Clin Res Inc.
Richmond, Virginia, United States
Buenos Aires Mácula
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
CICEMO- Consultorio de Investigación Clínica EMO
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires, , Argentina
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna, British Columbia, Canada
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
Centricity Research Brampton Endocrinology
Brampton, Ontario, Canada
Hamilton Medical Rsrch Grp
Hamilton, Ontario, Canada
Wharton Med Clin Trials
Hamilton, Ontario, Canada
Milestone Research
London, Ontario, Canada
Centricity Res Pointe-Claire
Pointe-Claire, Quebec, Canada
Diex Recherche Victoriaville
Victoriaville, Quebec, Canada
Opca bolnica Karlovac
Karlovac, , Croatia
Opca bolnica Karlovac
Karlovac, , Croatia
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
Krapinske Toplice, , Croatia
Poliklinika SLAVONIJA OSIJEK
Osijek, , Croatia
Poliklinika Solmed
Zagreb, , Croatia
Poliklinika Solmed
Zagreb, , Croatia
Lékařský dům Géčko
České Budějovice, , Czechia
Milan Kvapil s.r.o.
Prague, , Czechia
EUC Klinika Praha a.s.
Prague, , Czechia
Debreceni Egyetem
Debrecen, Hajdú-Bihar, Hungary
QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft
Budapest, Pest County, Hungary
Óbudai Egészségügyi Centrum
Budapest, Pest County, Hungary
Komáromi Selye János Kórház
Komárom, , Hungary
Diabmed Dr Popescu Alexandrina SRL
Ploieşti, Prahova, Romania
CMI Dr. Pletea Noemi SRL
Bacau, , Romania
Diabet Med SRL
Bucharest, , Romania
S.C Milena Sante SRL
Galati, , Romania
Clinica Korall S.R.L. Satu Mare
Satu Mare, , Romania
Nemocnica akademika L. Derera, UNB
Bratislava, , Slovakia
DIAB s.r.o.
Rožňava, , Slovakia
IRIDIA s.r.o.
Vrútky, , Slovakia
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Seoul National University Hospital
Seoul, , South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, , South Korea
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, , South Korea
Kyunghee University Medical Center
Seoul, , South Korea
Universitätsspital Basel
Basel, , Switzerland
Centre hospitalier universitaire vaudois CHUV
Lausanne, , Switzerland
Kantonsspital Olten
Olten, , Switzerland
Diabetes Adipositas Zentrum Zürich
Zollikerberg, , Switzerland
Oak Tree Surgery
Liskeard, Cornwall, United Kingdom
North Coast Medical Ltd
Newquay, Cornwall, United Kingdom
Brunel Medical Practice
Torquay, Devon, United Kingdom
Attenborough Surgery
Bushey, Hertfordshire, United Kingdom
Hammersmith and Fulham Partnership Research Unit - Richford Gate Primary Care Centre
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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U1111-1314-9328
Identifier Type: OTHER
Identifier Source: secondary_id
2024-519531-41
Identifier Type: OTHER
Identifier Source: secondary_id
NN9833-8243
Identifier Type: -
Identifier Source: org_study_id