Um estudo de fase 2b de 16 semanas para examinar a segurança e a eficácia de quatro regimes diferentes de MET-097 uma vez por semana (VESPER-1)
6 de agosto de 2026 atualizado por: Pfizer
Um estudo duplo-cego de fase 2b, multicêntrico, randomizado e controlado por placebo para investigar a segurança e eficácia de 16 semanas de quatro regimes diferentes de MET097 uma vez por semana em participantes com obesidade e sobrepeso
Este estudo foi desenvolvido para testar quão bem o MET097, um medicamento ativo, funciona no tratamento de indivíduos com obesidade ou sobrepeso quando comparado ao placebo.
MET097 ou placebo serão administrados aos indivíduos semanalmente durante 16 semanas.
Se um indivíduo for designado para MET097, ele receberá um dos quatro níveis de dose diferentes.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Este é um estudo multicêntrico, randomizado, duplo-cego e controlado por placebo para investigar a eficácia e segurança de quatro níveis de dose diferentes de MET097 vs. placebo para perda de peso corporal em participantes adultos com obesidade ou sobrepeso (índice de massa corporal [IMC ] 27 a 50 kg/m2, idades entre 18 e 70 anos), com 16 doses uma vez por semana.
Todos os participantes serão acompanhados por 11 semanas (~5 meias-vidas) após a administração da última dose semanal por segurança.
Tipo de estudo
Intervencional
Inscrição (Real)
239
Estágio
- Fase 2
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Critérios de inclusão:
Índice de massa corporal (IMC) na triagem de:
- IMC ≥30 kg/m2 e ≤50,0 kg/m2 (pode ter as comorbidades relacionadas ao peso listadas abaixo)
IMC ≥27,0 kg/m2 a <30,0 kg/m2 com pelo menos uma das seguintes comorbidades relacionadas ao peso:
- Hipertensão: em uso de medicação para baixar a pressão arterial (PA) ou com PA sistólica ≥130 mmHg ou PA diastólica ≥80 mmHg na triagem
- Dislipidemia: em uso de medicação hipolipemiante ou com colesterol de lipoproteína de baixa densidade (LDL-C) ≥160 mg/dL (4,1 mmol/L) ou triglicerídeos ≥150 mg/dL (1,7 mmol/L), ou lipoproteína de alta densidade- colesterol (HDL-C) <40 mg/dL (1,0 mmol/L) para homens ou HDL-C <50 mg/dL (1,3 mmol/L) para mulheres na triagem
Peso corporal estável (aumento ou diminuição ≤5 kg) nos 3 meses anteriores à triagem
Critérios de exclusão:
- Diagnóstico de diabetes (DM1 ou DM2) ou hemoglobina glicada A1c (HbA1c) ≥ 6,5% ou glicemia plasmática em jejum >125 mg/dL.
- Taxa de filtração glomerular estimada (TFGe) <75 mL/min/1,73 m2
- História de pancreatite
- História familiar ou pessoal de carcinoma medular de tireoide (CMT) ou síndrome de neoplasia endócrina múltipla tipo 2 (MEN-2)
- História de transtorno depressivo maior (TDM) ativo ou instável significativo ou outro transtorno psiquiátrico grave nos últimos 2 anos
- Qualquer história de tentativa de suicídio ao longo da vida.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: Placebo
Solução salina estéril a 0,9% (p/v) será usada como tratamento com placebo durante o estudo.
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Solução salina estéril a 0,9% (p/v) será usada como tratamento com placebo durante o estudo.
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Experimental: MET097 Ativo
MET097 será administrado em quatro níveis de dose diferentes por via subcutânea, uma vez por semana, sem titulação.
A fase de extensão inclui regimes posológicos menos frequentes do que semanais.
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MET097 é um análogo de ação ultralonga e totalmente tendencioso do GLP-1 humano.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percent Change From Baseline in Body Weight at Week 28: Part A
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Pfizer CT.gov Call Center, Pfizer
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
9 de outubro de 2024
Conclusão Primária (Real)
3 de julho de 2025
Conclusão do estudo (Real)
30 de abril de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
27 de novembro de 2024
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de novembro de 2024
Primeira postagem (Real)
2 de dezembro de 2024
Atualizações de registro de estudo
Última Atualização Postada (Real)
28 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
6 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VESPER-1 (MET097-24-201)
- C6491004 (Outro identificador: Alias Study Number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
produto fabricado e exportado dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .