Un estudio de fase 2b de 16 semanas para examinar la seguridad y eficacia de cuatro regímenes diferentes de MET-097 una vez a la semana (VESPER-1)
6 de agosto de 2026 actualizado por: Pfizer
Un estudio de fase 2b, multicéntrico, aleatorizado, doble ciego controlado con placebo para investigar la seguridad y eficacia de 16 semanas de cuatro regímenes diferentes de MET097 una vez a la semana en participantes con obesidad y sobrepeso
Este estudio está diseñado para probar qué tan bien funciona MET097, un fármaco activo, para tratar a personas con obesidad o sobrepeso en comparación con un placebo.
Se administrará MET097 o placebo a los individuos semanalmente durante 16 semanas.
Si a un individuo se le asigna MET097, recibirá uno de cuatro niveles de dosis diferentes.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Este es un estudio multicéntrico, aleatorizado, doble ciego y controlado con placebo para investigar la eficacia y seguridad de cuatro niveles de dosis diferentes de MET097 versus placebo para la pérdida de peso corporal en participantes adultos con obesidad o sobrepeso (índice de masa corporal [IMC] ] 27 a 50 kg/m2, de 18 a 70 años), con 16 dosis una vez a la semana.
Todos los participantes serán seguidos durante 11 semanas (~5 vidas medias) después de la administración de la última dosis semanal por seguridad.
Tipo de estudio
Intervencionista
Inscripción (Actual)
239
Fase
- Fase 2
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.
Ubicaciones de estudio
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California
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Anaheim, California, Estados Unidos, 92801
- Anaheim Clinical Trials, LLC
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Florida
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Hollywood, Florida, Estados Unidos, 92801
- Research Centers of America
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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
No
Descripción
Criterios de inclusión:
Índice de masa corporal (IMC) en el cribado de:
- IMC ≥30 kg/m2 y ≤50,0 kg/m2 (puede tener las comorbilidades relacionadas con el peso que se enumeran a continuación)
IMC ≥27,0 kg/m2 a <30,0 kg/m2 con al menos una de las siguientes comorbilidades relacionadas con el peso:
- Hipertensión: tomando medicamentos para reducir la presión arterial (PA) o teniendo PA sistólica ≥130 mmHg o PA diastólica ≥80 mmHg en el momento de la selección.
- Dislipidemia: en tratamiento con medicación hipolipemiante o con colesterol unido a lipoproteínas de baja densidad (LDL-C) ≥160 mg/dL (4,1 mmol/L) o triglicéridos ≥150 mg/dL (1,7 mmol/L), o lipoproteínas de alta densidad. colesterol (HDL-C) <40 mg/dL (1,0 mmol/L) para hombres o HDL-C <50 mg/dL (1,3 mmol/L) para mujeres en el cribado
Peso corporal estable (aumento o disminución ≤5 kg) dentro de los 3 meses anteriores a la selección
Criterios de exclusión:
- Diagnóstico de diabetes (DM1 o DM2) o hemoglobina glucosilada A1c (HbA1c) ≥ 6,5% o glucosa plasmática en ayunas >125 mg/dL.
- Tasa de filtración glomerular estimada (TFGe) <75 ml/min/1,73 m2
- Historia de pancreatitis
- Antecedentes familiares o personales de carcinoma medular de tiroides (MTC) o síndrome de neoplasia endocrina múltiple tipo 2 (MEN-2)
- Historial de trastorno depresivo mayor (TDM) activo o inestable significativo u otro trastorno psiquiátrico grave en los últimos 2 años
- Cualquier historial de por vida de un intento de suicidio.
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: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
Se utilizará solución salina estéril al 0,9% (p/v) como tratamiento placebo durante el estudio.
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Se utilizará solución salina estéril al 0,9% (p/v) como tratamiento placebo durante el estudio.
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Experimental: MET097 Activo
MET097 se administrará en cuatro niveles de dosis diferentes por vía subcutánea una vez a la semana sin titulación.
La fase de extensión incluye regímenes de dosificación que son menos frecuentes que los semanales.
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MET097 es un análogo totalmente sesgado y de acción ultralarga del GLP-1 humano.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent Change From Baseline in Body Weight at Week 28: Part A
Periodo de tiempo: Baseline (last non-missing measurement prior to the first dose), Week 28
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Analysis was performed using mixed model for repeated measures (MMRM) with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance.
The analysis excluded weight measurements after protocol specified intercurrent events (ICEs) including permanent treatment discontinuation, non-compliance to treatment and lifestyle change.
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Baseline (last non-missing measurement prior to the first dose), Week 28
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percent Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169: Part A
Periodo de tiempo: Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169
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Analysis was performed using MMRM with treatment group, visit, and treatment by visit interaction, sex, and baseline body weight as fixed effects using unstructured covariance excluding weight measurements after protocol specified intercurrent ICEs.
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Baseline, Day 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141 and 169
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Number of Participants With Reduction in Body Weight Greater Than or Equal to (>=) 5 Percent (%) From Baseline at Week 28: Part A
Periodo de tiempo: Baseline, Week 28
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Baseline, Week 28
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Number of Participants With Reduction in Body Weight >= 10 % From Baseline at Week 28: Part A
Periodo de tiempo: Baseline, Week 28
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Baseline, Week 28
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Number of Participants With Reduction in Body Weight >= 15 % From Baseline at Week 28: Part A
Periodo de tiempo: Baseline, Week 28
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Baseline, Week 28
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Change From Baseline in Body Weight at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Periodo de tiempo: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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Change From Baseline in Body Mass Index (BMI) at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Periodo de tiempo: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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BMI was derived from body weight in kilograms (kg) and height in meters (m), and it was calculated as weight divided by height^2.
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Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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Change From Baseline in Waist Circumference at Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197: Part A
Periodo de tiempo: Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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Baseline, Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 78, 85, 92, 99, 106, 113, 141, 169 and 197
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Number of Participants With Gastrointestinal (GI) Adverse Event of Clinical Interest (AECI): Part A
Periodo de tiempo: From Day 1 of dosing up to 28 days after last dose for Part A
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An adverse event (AE) was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment.
Gastrointestinal AECIs included nausea, vomiting and diarrhea.
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From Day 1 of dosing up to 28 days after last dose for Part A
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Number of Participants With Treatment Related Gastrointestinal AECIs: Part A
Periodo de tiempo: From Day 1 of dosing up to 28 days after last dose for Part A
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An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment.
Gastrointestinal AECIs included nausea, vomiting and diarrhea.
Treatment related gastrointestinal AECIs were GI AECIs that were related to study drug and relatedness was judged by investigator.
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From Day 1 of dosing up to 28 days after last dose for Part A
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Number of Participants With Gastrointestinal AECI and Treatment Related AECIs by Severity: Part A
Periodo de tiempo: From Day 1 of dosing up to 28 days after last dose for Part A
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An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which did not necessarily have a causal relationship with the treatment.
Gastrointestinal AECIs included nausea, vomiting and diarrhea.
Treatment related GI AECIs were GI AECIs that were related to study drug and relatedness was judged by investigator.
Severity was assessed as mild: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; moderate: minimal, local or non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living and severe: medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living or life-threatening consequences, urgent intervention indicated or death related to an AE.
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From Day 1 of dosing up to 28 days after last dose for Part A
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs: Part A
Periodo de tiempo: Up to Week 37
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An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which does not necessarily have a causal relationship with the treatment.
A TEAE was defined as any AE which on or after exposure to study treatment.
Treatment related TEAEs were TEAEs that were related to study drug and relatedness was judged by investigator.
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Up to Week 37
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Number of Participants With TEAEs and Treatment-Related TEAEs by Severity: Part A
Periodo de tiempo: Up to Week 37
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An AE was defined as any untoward medical occurrence in participant administered an investigational product and which does not necessarily have causal relationship with treatment.
A TEAE was defined as any AE which on or after exposure to study treatment up to 28 days following the last dose.
Treatment related TEAEs were TEAEs that were related to study drug and relatedness was judged by investigator.
Severity: mild: asymptomatic/ mild symptoms, clinical/ diagnostic observations only, intervention not indicated; moderate: minimal, local/ non-invasive intervention indicated, limiting age-appropriate instrumental activities of daily living and severe: medically significant but not immediately life-threatening, hospitalization/ prolongation of hospitalization indicated, disabling, limiting self-care activities of daily living/ life-threatening consequences, urgent intervention indicated/ death related to an AE.
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Up to Week 37
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Number of Participants With Abnormal Clinically Significant Physical Examination: Part A
Periodo de tiempo: From Day 1 of dosing up to post treatment follow up for Part A
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The physical examination included examination of the following body systems (at minimum): head and neck (including complete thyroid exam), cardiovascular, respiratory, gastrointestinal, brief neurological, and general appearance.
Clinical significance will be judged by investigator.
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From Day 1 of dosing up to post treatment follow up for Part A
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Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities: Part A
Periodo de tiempo: From Day 1 of dosing up to post treatment follow up for Part A
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Twelve lead ECGs were measured with the participant in a supine position after at least 5 minutes.
Clinical significance will be judged by investigator.
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From Day 1 of dosing up to post treatment follow up for Part A
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Number of Participants With Potential Clinically Significant Laboratory Values: Part A
Periodo de tiempo: From Day 1 of dosing up to post treatment follow up for Part A
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Laboratory parameters assessed included alanine aminotransferase (ALT) (units per liter [U/L]): greater than (>) 1*upper limit of normal (ULN), >3*ULN and >5*ULN; alkaline phosphatase (ALP) (U/L): >2*ULN; amylase (U/L): >1*ULN and >3*ULN; aspartate aminotransferase (AST): >1*ULN, >3*ULN and >5*ULN; estimated glomerular filtration rate (eGFR) (Ckd-Epi [chronic kidney disease epidemiology collaboration]) (milliliter per minute per 1.73m^2): less than (<) 60 mL/min/1.73m^2,
60-90 mL/min/1.73m^2
and >90 mL/min/1.73m^2;
Lipase: >1*ULN and >3*ULN; neutrophils: <1.5, <0.5, 0.5 to <1, 1 to <1.5 and total bilirubin (milligrams per deciliter): >2* upper limit of normal (ULN).
Potential clinical significance was judged by investigator.
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From Day 1 of dosing up to post treatment follow up for Part A
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Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) Categories: Part A
Periodo de tiempo: From Day 1 of dosing up to post treatment follow up for Part A
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The C-SSRS is a questionnaire designed for the assessment of suicidal ideation and behavior in adolescents and adults.
C-SSRS were evaluated through category 1 to 10. Suicidal ideation score was defined as the maximum suicidal ideation category (i.e., category 1-5), with 0 assigned if no ideation was present.
Suicidal ideation, defined as 'Yes' if 'Yes' was present in any of category 1-5 and suicidal behavior, defined as 'Yes' if 'Yes' was present in any of category 6-10 and suicidal ideation or behavior, defined as 'Yes' if 'Yes' was present in any of Category 1-10.
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From Day 1 of dosing up to post treatment follow up for Part A
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Patient Health Questionnaire-9 (PHQ-9) Total Score: Part A
Periodo de tiempo: From Day 1 of dosing up to post treatment follow up for Part A
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The PHQ-9 is a questionnaire designed to monitor and measure the severity of depression in participants.
The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead".
Each item was scored on scale of "0=not at all", "several days", "more than half the days" to "nearly every day".
The total score ranges from 0 to 27 by adding score for each question (total points) where: Score 1-4: minimal depression; Score 5-9: Mild depression; Score 10-14: moderate depression; Score 15-19 moderately severe depression; Score 20-27: Severe depression.
Higher score indicates greater severity of depression.
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From Day 1 of dosing up to post treatment follow up for Part A
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Number of Participants With Anti Drug Antibodies (ADAs): Part A
Periodo de tiempo: From Day 1 of dosing up to post treatment follow up for Part A
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Number of participants with baseline, positive and negative ADAs are reported in this outcome measure.
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From Day 1 of dosing up to post treatment follow up for Part A
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Minimum Observed Concentration (Cmin) of Berobenatide: Part A
Periodo de tiempo: From pre-dose on Day 1 up to 168 hours post-dose
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From pre-dose on Day 1 up to 168 hours post-dose
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Area Under the Concentration Versus Time Curve During the Dosing Interval (AUC[0-tau]) of Berobenatide: Part A
Periodo de tiempo: From pre-dose on Day 1 up to 168 hours post-dose
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AUCtau was area under the concentration versus time curve during the dosing interval (tau), where, tau=168 hours.
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From pre-dose on Day 1 up to 168 hours post-dose
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Maximum Observed Concentration (Cmax) of Berobenatide: Part A
Periodo de tiempo: From pre-dose on Day 1 up to 168 hours post-dose
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Cmax was observed directly from data.
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From pre-dose on Day 1 up to 168 hours post-dose
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Time to Maximum Concentration (Tmax) of Berobenatide: Part A
Periodo de tiempo: From pre-dose on Day 1 up to 168 hours post-dose
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From pre-dose on Day 1 up to 168 hours post-dose
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Plasma Concentration of Berobenatide: Part A
Periodo de tiempo: From pre-dose on Day 1 up to 168 hours post-dose
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From pre-dose on Day 1 up to 168 hours post-dose
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Percent Change From Baseline in Body Weight: Part B
Periodo de tiempo: Baseline (last available measurement prior to first dose received in Part A), End of study
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Baseline (last available measurement prior to first dose received in Part A), End of study
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Number of Participants With TEAEs: Part B
Periodo de tiempo: From Day 1 of dosing in Part B up to 28 days after last dose for Part B
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An AE was defined as any untoward medical occurrence in a participant administered an investigational product and which does not necessarily have a causal relationship with the treatment.
A TEAE was defined as any AE which on or after exposure to study treatment up to 28 days following the last dose.
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From Day 1 of dosing in Part B up to 28 days after last dose for Part B
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Pfizer CT.gov Call Center, Pfizer
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 (Actual)
9 de octubre de 2024
Finalización primaria (Actual)
3 de julio de 2025
Finalización del estudio (Actual)
30 de abril de 2026
Fechas de registro del estudio
Enviado por primera vez
27 de noviembre de 2024
Primero enviado que cumplió con los criterios de control de calidad
27 de noviembre de 2024
Publicado por primera vez (Actual)
2 de diciembre de 2024
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
28 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
6 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- VESPER-1 (MET097-24-201)
- C6491004 (Otro identificador: Alias Study Number)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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
producto fabricado y exportado desde los 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. .