A Trial Evaluating AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
31 de julio de 2026 actualizado por: Amgen
A Phase 1 Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 127 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
162
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
Ubicaciones de estudio
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California
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Lake Forest, California, Estados Unidos, 92630
- Reclutamiento
- Orange County Research Center
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Florida
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Aventura, Florida, Estados Unidos, 33180
- Reclutamiento
- Translational Clinical Research LLC
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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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria for Part A and B
- Participant must be 18-65 years of age
- Participant must be overtly healthy
Inclusion Criteria for Part C
- Participant must be 40-75 years of age
- Confirmed diagnoses of T2DM
Exclusion Criteria for Part A and B
- History of hypotension, syncope, or orthostatic intolerance
- Systolic blood pressure >140 millimeters of mercury (mmHg) or diastolic blood pressure >90 mmHg
Exclusion Criteria for Part C
- Hemoglobin A1c (HbA1c) >10% within the last 3 months
- History of hypotension, syncope, or orthostatic intolerance
- Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Part A: Single Ascending Dose (SAD)
Participants will receive single ascending doses of AMG 127 via subcutaneous (SC) injection.
One cohort will receive a single dose of AMG 127 as an intravenous (IV) infusion.
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AMG127 will be administered as either a SC injection or as an IV infusion.
|
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Experimental: Part B: Multiple Ascending Dose (MAD)
Participants will receive multiple ascending doses of AMG 127 via SC injection.
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AMG127 will be administered as either a SC injection or as an IV infusion.
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Experimental: Part C: Proof of Mechanism (PoM)
Participants will receive multiple doses of AMG 127 via SC injection.
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AMG127 will be administered as either a SC injection or as an IV infusion.
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Comparador de placebos: Placebo
Participants will receive a matching placebo as either a SC injection or as an IV infusion.
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Placebo will be administered as either a SC injection or as an IV infusion.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Number of Treatment-Emergent Adverse Events (TEAEs)
Periodo de tiempo: Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days)
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Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days)
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Number of Serious Adverse Events (SAEs)
Periodo de tiempo: Part A, SAD: Screening to end of trial (up to approximately 86 days); Part B, MAD: Screening to end of trial (up to approximately 114 days); Part C, PoM: Screening to end of trial (up to approximately 115 days)
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Part A, SAD: Screening to end of trial (up to approximately 86 days); Part B, MAD: Screening to end of trial (up to approximately 114 days); Part C, PoM: Screening to end of trial (up to approximately 115 days)
|
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Number of Adverse Events Leading to Study Discontinuation
Periodo de tiempo: Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days)
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Part A, SAD: Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Day 1 to end of trial (up to approximately 87 days)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Maximum Concentration (Cmax) of AMG 127
Periodo de tiempo: Part A, SAD: Predose on Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Predose on Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Predose on Day 1 to end of trial (up to approximately 87 days)
|
Part A, SAD: Predose on Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Predose on Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Predose on Day 1 to end of trial (up to approximately 87 days)
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Area Under the Curve (AUC) of AMG 127
Periodo de tiempo: Part A, SAD: Predose on Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Predose on Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Predose on Day 1 to end of trial (up to approximately 87 days)
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Part A, SAD: Predose on Day 1 to end of trial (up to approximately 58 days); Part B, MAD: Predose on Day 1 to end of trial (up to approximately 86 days); Part C, PoM: Predose on Day 1 to end of trial (up to approximately 87 days)
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Severity of Retinal Structural Abnormalities Assessed by Optical Coherence Tomography (OCT) in Participants With Type 2 Diabetes Mellitus
Periodo de tiempo: Part A, SAD: Screening to end of trial (up to approximately 86 days); Part B, MAD: Screening to end of trial (up to approximately 114 days); Part C, PoM: Screening to end of trial (up to approximately 115 days)
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Part A, SAD: Screening to end of trial (up to approximately 86 days); Part B, MAD: Screening to end of trial (up to approximately 114 days); Part C, PoM: Screening to end of trial (up to approximately 115 days)
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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.
Enlaces Útiles
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 (Actual)
11 de junio de 2026
Finalización primaria (Estimado)
2 de octubre de 2027
Finalización del estudio (Estimado)
2 de octubre de 2027
Fechas de registro del estudio
Enviado por primera vez
11 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
11 de mayo de 2026
Publicado por primera vez (Actual)
15 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
31 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 20250058
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
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