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Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity and Type 2 Diabetes

Status: Active_not_recruiting
Location: See all (64) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.

• 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\*)

Locations
United States
Alabama
Univ of Alabama_Birmingham
Birmingham
Chambliss Clinical Trials, LLC
Montgomery
Arizona
Elite Clinical Network - Tucson
Tucson
California
Scripps Whittier Diabetes Inst
La Jolla
Clinical Trials Research
Lincoln
Pacific Clinical Studies
Los Alamitos
Florida
Walgreens - Store 4442
Kissimmee
Optimal Research Sites
Orange City
Center for Diab,Obes & Metab
Pembroke Pines
Palm Beach Research Center
West Palm Beach
Hawaii
East West Med Res Inst
Honolulu
Indiana
MediSphere Medical RC
Evansville
North Carolina
Centricity Res New Bern Multispeciality
New Bern
Accellacare
Wilmington
Nevada
Walgreens - Store 3915
Las Vegas
New York
Chear Center LLC
The Bronx
South Carolina
Spartanburg Medical Research
Spartanburg
Tennessee
Holston Medical Group_Bristol
Bristol
Texas
Velocity Clinical Res-Dallas
Dallas
Virginia
TPMG Clinical Research
Newport News
National Clin Res Inc.
Richmond
Other Locations
Argentina
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires
Buenos Aires Mácula
Ciudad Autonoma De Buenos Aires
CICEMO- Consultorio de Investigación Clínica EMO
Ciudad Autonoma De Buenos Aires
Canada
Centricity Research Brampton Endocrinology
Brampton
Nova Scotia Hlth Halifax
Halifax
Hamilton Medical Rsrch Grp
Hamilton
Wharton Med Clin Trials
Hamilton
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna
Milestone Research
London
G.A. Research Associates Ltd.
Moncton
Centricity Res Pointe-Claire
Pointe-claire
Diex Recherche Victoriaville
Victoriaville
Croatia
Opca bolnica Karlovac
Karlovac
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
Krapinske Toplice
Poliklinika SLAVONIJA OSIJEK
Osijek
Poliklinika Solmed
Zagreb
Hungary
Óbudai Egészségügyi Centrum
Budapest
QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft
Budapest
Debreceni Egyetem
Debrecen
Komáromi Selye János Kórház
Komárom
Republic of Korea
Chonnam National University Hospital
Gwangju
Kyunghee University Medical Center
Seoul
Seoul National University Hospital
Seoul
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul
Pusan National University Yangsan Hospital
Yangsan
Romania
CMI Dr. Pletea Noemi SRL
Bacau
Diabet Med SRL
Bucharest
S.C Milena Sante SRL
Galati
Diabmed Dr Popescu Alexandrina SRL
Ploieşti
Clinica Korall S.R.L. Satu Mare
Satu Mare
Slovakia
Nemocnica akademika L. Derera, UNB
Bratislava
DIAB s.r.o.
Rožňava
IRIDIA s.r.o.
Vrútky
Switzerland
Universitätsspital Basel
Basel
Centre hospitalier universitaire vaudois CHUV
Lausanne
Kantonsspital Olten
Olten
Diabetes Adipositas Zentrum Zürich
Zollikerberg
United Kingdom
Attenborough Surgery
Bushey
Oak Tree Surgery
Liskeard
Hammersmith and Fulham Partnership Research Unit - Richford Gate Primary Care Centre
London
North Coast Medical Ltd
Newquay
Brunel Medical Practice
Torquay
Time Frame
Start Date: 2025-11-05
Completion Date: 2027-06-30
Participants
Target number of participants: 330
Treatments
Experimental: Cagrilintide
Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.
Placebo_comparator: Placebo
Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.
Related Therapeutic Areas
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov

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