Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes (MARITIME-T2D-3)
A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes
The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Contato de estudo
- Nome: Amgen Call Center
- Número de telefone: 866-572-6436
- E-mail: medinfo@amgen.com
Locais de estudo
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British Columbia
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Vancouver, British Columbia, Canadá, V5Y 3W2
- Recrutamento
- Dr T G Elliott Incorporated - BC Diabetes
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California
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San Diego, California, Estados Unidos, 92120
- Recrutamento
- Acclaim Clinical Research
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Florida
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Miami, Florida, Estados Unidos, 33155
- Recrutamento
- Bioclinical Research Alliance
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Miami Lakes, Florida, Estados Unidos, 33016
- Recrutamento
- Indago Research and Health Center
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Pompano Beach, Florida, Estados Unidos, 33060
- Recrutamento
- Clinical Research Center Of Florida
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Winter Park, Florida, Estados Unidos, 32789
- Recrutamento
- Conquest Research - Winter Park
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Virginia
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Arlington, Virginia, Estados Unidos, 22205
- Recrutamento
- Virginia Nephrology Group
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Washington
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Redmond, Washington, Estados Unidos, 98052
- Recrutamento
- Eastside Research Associates Health Research
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.
- Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization.
- Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m^2) at screening.
Exclusion Criteria:
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Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.
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Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
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Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.
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One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
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History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
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Self-reported change in body weight > 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.
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Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:
- liposuction and/or abdominoplasty that was performed > 1 year before screening.
- laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed > 1 year before screening.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Maridebart cafraglutide
Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner. |
Administered subcutaneously.
Outros nomes:
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Comparador Ativo: Semaglutide
Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner. |
Administered subcutaneously. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
Prazo: Baseline to Week 68
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Baseline to Week 68
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Plasma Concentration of Maridebart Cafraglutide at Week 68
Prazo: Week 68
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Week 68
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Change from Baseline in HbA1c at week 68 [Superiority]
Prazo: Baseline to Week 68
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Baseline to Week 68
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|
Percent Change from Baseline in Body Weight at Week 68
Prazo: Baseline to Week 68
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Baseline to Week 68
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|
Percentage of Participants Achieving HbA1c < 7.0% at Week 68
Prazo: Week 68
|
Week 68
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Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
Prazo: Week 68
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Week 68
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Percentage of Participants Achieving HbA1c < 5.7% at Week 68
Prazo: Week 68
|
Week 68
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Change from Baseline in Fasting Plasma Glucose at Week 68
Prazo: Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68
Prazo: Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68
Prazo: Baseline to Week 68
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Baseline to Week 68
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Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68
Prazo: Baseline to Week 68
|
Baseline to Week 68
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Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68
Prazo: Baseline to Week 68
|
Baseline to Week 68
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Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Prazo: Up To 81 Weeks
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Up To 81 Weeks
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Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes
Prazo: Up To 81 Weeks
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Up To 81 Weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: MD, Amgen
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças do Sistema Endócrino
- Distúrbios Nutricionais
- Doenças Metabólicas
- Supernutrição
- Distúrbios do Metabolismo da Glicose
- Diabetes Mellitus
- Condições Patológicas, Sinais e Sintomas
- Doenças Nutricionais e Metabólicas
- Sinais e sintomas
- Excesso de peso
- Obesidade
- Diabetes Mellitus, Tipo 2
- Peso corporal
- Semaglutide
Outros números de identificação do estudo
- 20230220
- 2025 (Concessão/Contrato do NIH dos EUA)
- 2025-523772-22-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
- CSR
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