Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) 1.0 mg/1.0 mg s.c. Once Weekly Versus Tirzepatide 5 mg s.c. Once Weekly in Participants With Type 2 Diabetes Inadequately Controlled on Metformin, SGLT2 Inhibitor or Both

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06534411Tipo: INTERVENTIONALInicio: 5 de nov de 2024Fin estimado: 14 de jul de 2026

Traducción no disponible, mostrando original

Resumen

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male or female (sex at birth).
Age 18 years or above at the time of signing the informed consent.
Diagnosed with type 2 diabetes mellitus greater than or equal to (\>=) 180 days before screening.
Stable daily dose(s) \>= 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator:
Metformin
sodium-glucose co-transporter 2 inhibitor (SGLT2i)
Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mol \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
Body mass index (BMI) \>= 30 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Criterios de exclusión

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
Renal impairment with estimated Glomerular Filtration Rate less than \< 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.

Intervenciones

drug

Cagrilintide

Participants will receive once-weekly cagrilintide subcutaneously.

drug

Semaglutide

Participants will receive once-weekly semaglutide subcutaneously.

drug

Tirzepatide

Participants will receive once-weekly tirzepatide subcutaneously.

Ubicaciones

Centro Médico CIMEL

Lanús Este, Buenos Aires, Argentina

Centro de Investigaciones Médicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Fundación CESIM

Santa Rosa, La Pampa Province, Argentina

Centro de Investigaciones Médicas Tucumán

San Miguel de Tucuimán, Tucumán Province, Argentina

IMOBA

City of Buenos Aires, Argentina

Centro de Investigaciones Metabólicas

City of Buenos Aires, Argentina

Instituto de Investigaciones Clinicas San Nicolás

San Nicolás, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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