Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
Phase 3 – large-scale trial before approval
Conditions:
Overweight
Obesity
Type 2 Diabetes
Sponsor: Novo Nordisk A/S
trial.available_in:
БГ
Overview
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.
Who can participate
Key Inclusion Criteria:
* 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\*)
Key Exclusion Criteria:
* Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a\*)
* Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomized according to inclusion criteria 7bi.(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.
Interventions
Cagrilintide
DRUG
Placebo (matched to Cagrilintide)
DRUG
Locations
67
Argentina (3)
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli
Buenos Aires
Buenos Aires Mácula
Ciudad Autonoma de Buenos Aires , Buenos Aires
CICEMO- Consultorio de Investigación Clínica EMO
Ciudad Autonoma de Buenos Aires , Buenos Aires
Canada (9)
Centricity Research Brampton Endocrinology
Brampton , Ontario
Nova Scotia Hlth Halifax
Halifax , Nova Scotia
Hamilton Medical Rsrch Grp
Hamilton , Ontario
Wharton Medical Clinic Clinical Trials (Hamilton)
Hamilton , Ontario
OCT Research ULC (dba Okanagan Clinical Trials)
Kelowna , British Columbia
Milestone Research
London , Ontario
G.A. Research Associates Ltd.
Moncton , New Brunswick
Centricity Res Pointe-Claire
Pointe-Claire , Quebec
Diex Recherche Victoriaville
Victoriaville , Quebec
Croatia (4)
Opca bolnica Karlovac
Karlovac
Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology
Krapinske Toplice
Poliklinika SLAVONIJA OSIJEK
Osijek
Poliklinika Solmed
Zagreb
Czech Republic (3)
Lékařský dům Géčko
České Budějovice
Milan Kvapil s.r.o.
Prague
EUC Klinika Praha a.s.
Prague
Hungary (4)
QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft
Budapest , Pest County
Óbudai Egészségügyi Centrum
Budapest , Pest County
Debreceni Egyetem
Debrecen , Hajdú-Bihar
Komáromi Selye János Kórház
Komárom
Romania (5)
CMI Dr. Pletea Noemi SRL
Bacau
Diabet Med SRL
Bucharest
S.C Milena Sante SRL
Galati
Diabmed Dr Popescu Alexandrina SRL
Ploieşti , Prahova
Clinica Korall S.R.L. Satu Mare
Satu Mare
Slovakia (3)
Nemocnica akademika L. Derera, UNB
Bratislava
DIAB s.r.o.
Rožňava
IRIDIA s.r.o.
Vrútky
South Korea (6)
Chonnam National University Hospital
Gwangju
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
Kyunghee University Medical Center
Seoul
Pusan National University Yangsan Hospital
Yangsan , Gyeongsangnam-do
Switzerland (4)
Universitätsspital Basel
Basel
Centre hospitalier universitaire vaudois CHUV
Lausanne
Kantonsspital Olten
Olten
Diabetes Adipositas Zentrum Zürich
Zollikerberg
United Kingdom (5)
Attenborough Surgery
Bushey , Hertfordshire
Oak Tree Surgery
Liskeard , Cornwall
Hammersmith and Fulham Partnership Research Unit - Richford Gate Primary Care Centre