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Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations After Multiple Doses

2 de noviembre de 2026 actualizado por: Amgen

A Phase 1, Open-label, Randomized, Parallel Group, Multiple Dose Study to Assess the Relative Bioavailability of Maridebart Cafraglutide (AMG 133) as Two Subcutaneous Presentations in Participants Living With Overweight or Obesity

The main objective of this study is to compare the pharmacokinetics of maridebart cafraglutide administered as a single dose using two different subcutaneous (SC) presentations in participants with overweight or obesity after they have received escalating doses of the study drug.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

356

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Amgen Call Center
  • Número de teléfono: 866-572-6436
  • Correo electrónico: medinfo@amgen.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 60 años (Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Adults 18 to 60 years of age.
  • Body mass index (BMI) between 25 and 35 kilograms per square meter (kg/m^2), inclusive.
  • Stable body weight, with less than 5 kilograms (kg) (11 pounds) of weight change in the past 3 months.
  • No significant changes in diet or eating habits in the past 3 months.
  • Generally healthy. People with certain well-controlled medical conditions, such as sleep apnea, high blood pressure, high cholesterol, or underactive thyroid, may qualify if their treatment has been stable for at least 3 months and is approved by the study doctor.
  • Willing to follow the study's birth control requirements, if applicable, during the study and for the study-defined period after the last dose of study drug.
  • Able and willing to provide informed consent before participating in study procedures.

Exclusion Criteria:

  • History of diabetes or current diabetes, except diabetes during pregnancy, or blood sugar levels that meet the study's definition of diabetes.
  • Certain hormonal conditions that can cause weight gain, such as Cushing's syndrome.
  • History of pancreatitis (inflammation of the pancreas) or certain abnormal pancreatic blood test results.
  • History of cancer within the past 5 years, except certain early-stage cancers or nonmelanoma skin cancers.
  • Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2 (MEN2).
  • Uncontrolled thyroid disease or certain abnormal thyroid blood test results.
  • Significant stomach or intestinal conditions, including delayed stomach emptying, ulcers, or inflammatory bowel disease, or a history of certain digestive system surgeries.
  • Weight-loss surgery within the past 6 months.
  • Significant heart disease, abnormal heart rhythms, or blood pressure or heart rate outside the study's allowed limits.
  • Significant kidney or liver problems, or certain abnormal kidney or liver blood test results.
  • Positive tests for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C, with certain exceptions for past hepatitis B vaccination or infection.
  • History of certain serious or unstable mental health conditions, self-injury within the past 5 years, or any previous suicide attempt.
  • History of ischemic optic neuropathy, a condition involving damage to the optic nerve caused by reduced blood flow.
  • Allergy or intolerance to maridebart cafraglutide (AMG 133), similar medications, or their ingredients.
  • Use of certain medications, including weight-loss or diabetes medications that act on glucagon-like peptide-1 (GLP-1) or glucose-dependent insulinotropic polypeptide (GIP), within the restricted time periods before the study.
  • Use of certain herbal products, vitamins, or supplements within 30 days before enrollment, unless approved by the study doctor.
  • Recent participation in another investigational drug study or previous participation in a study of maridebart cafraglutide.
  • History of alcohol or drug abuse, recent illegal drug use, or positive alcohol or drug screening results not explained by permitted prescription medications.
  • Pregnant, breastfeeding, or planning to breastfeed during the study or within the study-defined period after the last dose of study drug.
  • Recent blood, plasma, or platelet donation within the study's restricted time periods.
  • Recent strenuous exercise or unwillingness to follow study restrictions on physical activity, alcohol, recreational drugs, diet, or other activities.
  • Difficulty providing blood samples because of poor vein access.
  • Any other medical condition, abnormal test result, or circumstance that the study doctor believes could make participation unsafe or interfere with study procedures.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Maridebart Cafraglutide: SC Presentation 1

Participants will receive maridebart cafraglutide administered subcutaneously (SC) during the initial dose-escalation period and, after randomization, will continue to receive maridebart cafraglutide SC administered using SC Presentation 1.

Administered subcutaneously.

Otros nombres:
  • AMG 133
  • Marituro
Experimental: Maridebart Cafraglutide: SC Presentation 2

Participants will receive maridebart cafraglutide administered SC during the initial dose-escalation period and, after randomization, will continue to receive maridebart cafraglutide SC administered using SC Presentation 2.

Administered subcutaneously.

Otros nombres:
  • AMG 133
  • Marituro

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Area Under the Plasma Concentration-time Curve from Time 0 to 28 days post dose (AUC 0-28) of Maridebart Cafraglutide
Periodo de tiempo: Up to 113 days
Up to 113 days
Maximum Observed Plasma Concentration (Cmax) of Maridebart Cafraglutide
Periodo de tiempo: Up to 113 days
Up to 113 days

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: TEAEs: From baseline (Day 1) up to end of trial (approximately 28 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 32 weeks)
TEAEs: From baseline (Day 1) up to end of trial (approximately 28 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 32 weeks)
Number of Participants Who Develop Anti-Maridebart Cafraglutide Antibodies
Periodo de tiempo: Baseline (Day 1) up to end of trial (approximately 28 weeks)
Baseline (Day 1) up to end of trial (approximately 28 weeks)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: MD, Amgen

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

9 de noviembre de 2026

Finalización primaria (Estimado)

26 de julio de 2027

Finalización del estudio (Estimado)

26 de julio de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de noviembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Publicado por primera vez (Actual)

6 de noviembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Marco de tiempo para compartir IPD

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Criterios de acceso compartido de IPD

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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