Clinical trial

Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

Active, not recruiting · Phase 3 · 9 countries · Registry ID NCT07220759

Active, not recruitingPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Obesity, Type 2 Diabetes

Full registry criteria

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). * Diagnosed with type 2 diabetes \>= 180 days before screening.(a\*) * 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.

Treatments and study arms

Cagrilintide

Drug

Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Placebo (matched to Cagrilintide)

Drug

Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Primary outcomes

Relative change in body weightFrom baseline (week 0) to end of treatment (week 64)

Measured as percentage (%) of body weight.

Study locations

67 locations were listed when this page was built. The first 40 are shown.

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli🇦🇷 Buenos Aires, Argentina
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
Centricity Research Brampton Endocrinology🇨🇦 Brampton, Ontario, Canada
Nova Scotia Hlth Halifax🇨🇦 Halifax, Nova Scotia, Canada
Hamilton Medical Research Group🇨🇦 Hamilton, Ontario, Canada
Wharton Medical Clinic Clinical Trials (Hamilton)🇨🇦 Hamilton, Ontario, Canada
OCT Research ULC (dba Okanagan Clinical Trials)🇨🇦 Kelowna, British Columbia, Canada
Milestone Research🇨🇦 London, Ontario, Canada
G.A. Research Associates Ltd.🇨🇦 Moncton, New Brunswick, Canada
Centricity Res Pointe-Claire🇨🇦 Pointe-Claire, Quebec, Canada
Diex Recherche Victoriaville🇨🇦 Victoriaville, Quebec, Canada
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
EUC Klinika Praha a.s.🇨🇿 Prague, Czechia
Milan Kvapil s.r.o.🇨🇿 Prague, Czechia
Lékařský dům Géčko🇨🇿 České Budějovice, Czechia
QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft🇭🇺 Budapest, Pest County, Hungary
Óbudai Egészségügyi Centrum🇭🇺 Budapest, Pest County, Hungary
Debreceni Egyetem🇭🇺 Debrecen, Hajdú-Bihar, Hungary
Komáromi Selye János Kórház🇭🇺 Komárom, Hungary
CMI Dr. Pletea Noemi SRL🇷🇴 Bacau, Romania
Diabet Med SRL🇷🇴 Bucharest, Romania
S.C Milena Sante SRL🇷🇴 Galati, Romania
Diabmed Dr Popescu Alexandrina SRL🇷🇴 Ploieşti, Prahova, 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
Chonnam National University Hospital🇰🇷 Gwangju, South Korea
Kyunghee University Medical Center🇰🇷 Seoul, 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
Pusan National University Yangsan Hospital🇰🇷 Yangsan, Gyeongsangnam-do, South Korea
Universitätsspital Basel🇨🇭 Basel, Switzerland
Centre hospitalier universitaire vaudois CHUV🇨🇭 Lausanne, Switzerland
Kantonsspital Olten🇨🇭 Olten, Switzerland