A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06858839Tipo: INTERVENTIONALInicio: 12 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 ≥ 30 kg/m2 or ≥27 kg/m² to \< 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).
History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Criterios de exclusión

Type 1 or Typ2 diabetes mellitus.
Obesity induced by other endocrinologic disorders.
Self-reported change in body weight \> 5 kg within 90 days before screening.
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 administered SC.

drug

Placebo

Placebo will be administered SC.

Ubicaciones

Cedic - Centro de Investigacion Clinica

CABA, Buenos Aires, Argentina

Centro Medico Viamonte

CABA, Buenos Aires, Argentina

Cemedic Centro de Especialidades Medicas

CABA, Buenos Aires, Argentina

Centro Medico Dra Laura Maffei Investigacion Clinica Aplicada

CABA, Buenos Aires, Argentina

Consultorios Medicos Dr Besada

CABA, Buenos Aires, Argentina

Fundacion Respirar

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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