Programa de desarrollo aleatorizado, multicéntrico, doble ciego y controlado con placebo para evaluar la eficacia y seguridad de NNC0487-0111 s.c. una vez a la semana en comparación con semaglutida s.c. una vez a la semana en participantes con sobrepeso u obesidad y diabetes tipo 2 (AMAZE 8)

Aún no reclutaFase 3ClinicalTrials.gov

ID: NCT07400107Tipo: INTERVENTIONALInicio: 20 de may de 2026Fin estimado: 26 de ene de 2029

Resumen

El propósito de este estudio clínico es determinar si NNC0487-0111 es seguro y eficaz para tratar a personas con exceso de peso corporal y diabetes tipo 2. Los participantes recibirán 2 inyecciones por semana: un medicamento activo y un placebo, ambos administrados como inyecciones subcutáneas una vez a la semana. El placebo es un tratamiento sin medicamento activo y se administrará a todos los participantes. Además del placebo, los participantes recibirán el medicamento activo NNC0487-0111 (el tratamiento en evaluación) o semaglutida (un tratamiento aprobado y de uso frecuente utilizado como comparador). El tratamiento que recibe cada participante se determina por azar.

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 informed consent.
Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
Haemoglobin A1c (HbA1c) 7-10 percentage (%) (53-86 millimole per mole \[mmol/mol\]) (both inclusive) as measured by the central laboratory at screening.
Treatment with lifestyle intervention, and/or 0-3 marketed oral antidiabetic drugs (OAD)s (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and dosing frequency) before screening.

Criterios de exclusión

Renal impairment with estimated Glomerular Filtration Rate (eGFR) \< 30 milliliter (mL)/ minute (min)/1.73 meter squared (m\^2) (2021 Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula), at screening.
Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening or in the period between screening and randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.

Intervenciones

drug

Placebo (matched to NNC0487-0111)

Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

drug

Placebo (matched to semaglutide)

Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

drug

Semaglutide

Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

drug

NNC0487-0111

NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Ubicaciones

Centro de Investigaciones Metabólicas

Capital Federal, Buenos Aires, Argentina

Centro Médico CIMEL

Lanús Este, Buenos Aires, Argentina

Centro Médico Privado San Vicente Diabetes

Córdoba, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

Contactos

Novo Nordisk

CONTACT

clinicaltrials@novonordisk.com (+1) 866-867-7178

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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