- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07626515
A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Enicepatide in Generally Healthy Adult Chinese Participants
A Phase I, Randomized, Double-Blinded, Placebo-Controlled, Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Enicepatide in Adult Chinese Participants With Body Mass Index ≥23.0 kg/m2
This is a Phase I, randomized, double-blinded, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics (PK) of enicepatide in generally healthy adult Chinese participants with body mass index (BMI) ≥23.0 kilograms per meter squared (kg/m^2).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Beijing, Porcelana, 100034
- Peking University First Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- No evidence of active or chronic disease as determined by detailed medical and surgical history and the results of a physical examination, vital signs, 12 lead electrocardiogram (ECG), or clinical laboratory tests
- BMI ≥23 kg/m^2 at screening
- Agreement to adhere to the contraception requirements
Exclusion Criteria:
- History of acute or chronic pancreatitis
- History of clinically significant gallbladder disease in the opinion of the investigator
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder
- History or presence of an abnormal ECG that is deemed clinically significant in the opinion of the investigator
- Clinically significant abnormalities (as judged by the investigator) in laboratory test results
- History or presence of clinically significant cardiovascular disease, renal disease, hepatic disease, gastrointestinal disease, hematological disease, immunological disease, neurological disease, endocrine disease, metabolic disease, pulmonary disease, or history of any of these diseases with renal, hepatic, or cardiopulmonary dysfunction
Plan de estudios
¿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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Comparador de placebos: Placebo
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Participants will receive matching placebo via subcutaneous (SC) injection as per the schedule in the protocol. |
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Experimental: Enicepatide Dose 1
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Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Otros nombres:
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Experimental: Enicepatide Dose 2
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Participants will receive enicepatide via subcutaneous (SC) injection as per the schedule in the protocol.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Incidence and Severity of Adverse Events
Periodo de tiempo: Baseline to Safety Follow-Up (27 weeks)
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Baseline to Safety Follow-Up (27 weeks)
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Number of Participants with Abnormal Clinical Laboratory Parameters as a Shift from Baseline to Maximum Postbaseline Severity Grade
Periodo de tiempo: Baseline to Safety Follow-Up (27 weeks)
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Baseline to Safety Follow-Up (27 weeks)
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Change from Baseline in Pulse Rate
Periodo de tiempo: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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Change from Baseline in Respiratory Rate
Periodo de tiempo: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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Change from Baseline in Systolic Blood Pressure
Periodo de tiempo: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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Change from Baseline in Diastolic Blood Pressure
Periodo de tiempo: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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Change from Baseline in Body Temperature
Periodo de tiempo: At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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At prespecified time points from Baseline to Safety Follow-Up (27 weeks)
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Plasma Concentration of Enicepatide
Periodo de tiempo: At prespecified time points from Day 1 to Day 190
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At prespecified time points from Day 1 to Day 190
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Maximum Plasma Concentration Observed (Cmax) of Enicepatide
Periodo de tiempo: At prespecified time points from Day 1 to Day 190
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At prespecified time points from Day 1 to Day 190
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Time to Cmax (Tmax) of Enicepatide
Periodo de tiempo: At prespecified time points from Day 1 to Day 190
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At prespecified time points from Day 1 to Day 190
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Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUClast) of Enicepatide
Periodo de tiempo: At prespecified time points from Day 1 to Day 190
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At prespecified time points from Day 1 to Day 190
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Percentage of Participants With Treatment Emergent Anti-Drug Antibodies (ADAs) to Enicepatide
Periodo de tiempo: At prespecified time points from Day 1 to Day 190
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At prespecified time points from Day 1 to Day 190
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Absolute Change From Baseline in Body Weight
Periodo de tiempo: Baseline through Week 24
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Baseline through Week 24
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Percent Change From Baseline in Body Weight
Periodo de tiempo: Baseline through Week 24
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Baseline through Week 24
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Clinical Trials, Hoffmann-La Roche
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- YP46402
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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. .