A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06858878Tipo: INTERVENTIONALInicio: 17 de mar de 2025Fin estimado: 16 de abr de 2027

Traducción no disponible, mostrando original

Resumen

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 99 YearsSexo: ALL

Criterios de inclusión

Age ≥ 18 years.
Body mass index ≥ 27 kg/m\^2.
History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
Diagnosis of T2DM.

Criterios de exclusión

Type 1 diabetes mellitus.
Self-reported change in body weight \> 5 kg within 90 days before screening.
Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
Obesity induced by other endocrinologic disorders.
Family (first-degree relative\[s\]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.
History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
Lifetime history of suicide attempt.

Intervenciones

drug

Maridebart cafraglutide

Maridebart cafraglutide will be adminstered SC.

drug

Placebo

Placebo will be adminstered SC.

Ubicaciones

Centro Medico Viamonte

CABA, Buenos Aires, Argentina

Cedic Centro de Investigacion Clinica

CABA, Buenos Aires, Argentina

Cemedic Centro de Especialidades Medicas

CABA, Buenos Aires, Argentina

Maffei Centro Medico

CABA, Buenos Aires, Argentina

Consultorios Medicos Dr Besada

CABA, Buenos Aires, Argentina

Cinme - Centro de Investigaciones Metabolicas

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Ciprec Centro de Investigacion y Prevencion Cardiovascular

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Patrocinadores

PrincipalAmgen

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