Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor

CompletadoFase 3ClinicalTrials.gov

ID: NCT06065540Tipo: INTERVENTIONALInicio: 27 de sept de 2023Fin estimado: 6 de ene de 2026

Traducción no disponible, mostrando original

Resumen

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

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) greater than or equal to 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 with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.
Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( 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.

Criterios de exclusión

Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m\^2) as determined by central laboratory at screening.

Intervenciones

drug

Cagrilintide

Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose 1 and dose 2 of cagrilintide is reached.

drug

Semaglutide

Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose 1 and dose 2 of semaglutide is reached.

drug

Placebo cagrilintide

Participants will receive placebo matched to cagrilintide subcutaneously.

drug

Placebo semaglutide

Participants will receive placebo matched to semaglutide subcutaneously.

Ubicaciones

Mautalen Salud e investigación

CABA, Buenos Aires, Argentina

Sanatorio Güemes

CABA, City of Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Rosario

Rosario, Santa Fe Province, Argentina

STAT Research

Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

Buenos Aires, Argentina

Centro de Investigación y Prevención Cardiovascular

CABA, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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