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

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT07220759Tipo: INTERVENTIONALInicio: 5 de nov de 2025Fin estimado: 30 de jun de 2027

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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\*)
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.

Criterios de exclusión

Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a\*)

Intervenciones

drug

Cagrilintide

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

drug

Placebo (matched to Cagrilintide)

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

Ubicaciones

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

Patrocinadores

PrincipalNovo Nordisk A/S

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