Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus
A Prospective, Multicenter, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is an approved and well-established therapy for type 2 diabetes mellitus (T2DM), providing both robust glycemic control and weight reduction. Semaglutide Depot, is a long-acting formulation of semaglutide, designed for once every four weeks administration, intended to reduce treatment burden, and improve adherence supporting sustained glycemic control over time.
This Phase I/Ila dose escalation study design to evaluate the safety, tolerability, pharmacokinetics and efficacy of Semaglutide Depot in adults with T2DM.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Study Title:
A Prospective, Multicenter, Open-Label, Dose Escalation Phase I/Ila Study to Assess the Safety, Tolerability, and Efficacy of Semaglutide Depot in Subjects with Type 2 Diabetes Mellitus
Background:
Type 2 diabetes mellitus (T2DM) is a chronic condition in which the body cannot properly use insulin, leading to elevated blood glucose levels. It is often associated with overweight or obesity and can lead to serious complications if not well controlled.
Semaglutide, is a GLP 1 receptor agonist, that helps lower blood glucose by increasing insulin secretion, reducing glucagon (a hormone that raises blood glucose), slowing gastric emptying, and reducing appetite. In addition to improving glycemic control, it also supports weight loss and has demonstrated cardiovascular benefits. Semaglutide is already approved in several formulations (examples: Ozempic® for type 2 diabetes and Wegovy® for weight management), but these require once-weekly injections.
Semaglutide Depot (SG Depot) is a new, long-acting formulation developed by Mapi Pharma Ltd. It is designed to be injected once every 4 weeks (once monthly), which may make treatment easier and improve adherence for people with diabetes.
Study Design:
- Type: Phase I/Ila, open label, dose escalation study, prospective study
- Sponsor: Mapi Pharma Ltd., Ness Ziona, Israel
- Sites: Tel Aviv, Israel
- Participants: Up to 24 adults with type 2 diabetes
- Groups: Participants will be divided into 4 sequential dose cohorts: 2 mg, 4 mg, 6 mg and 8 mg
- Dose escalation: will be allowed only after review of safety data
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Contato de estudo
- Nome: Roy Eldor, Professor
- Número de telefone: 972-36974243
- E-mail: roye@tlvmc.gov.il
Locais de estudo
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Tel Aviv, Israel, 6423906
- Recrutamento
- Mapi pharma Investigational Site ISR001
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Adults aged 18-64 years with T2DM, BMI 25-35 kg/m2
- On stable Semaglutide 1 mg weekly and for at least 3 months
- HbA1c <8%, eGFR≥60 ml/minute
- For women: either non-childbearing potential or agreement to use acceptable contraception
Exclusion Criteria:
- Participation in another investigational drug clinical study within 3 months
- History of cardiovascular or cerebrovascular disease
- Neuropathy or retinopathy or macular edema necessitating medical treatment
- Type 1 diabetes
- Unstable weight (> 5% change in the last 3 months)
- Current use of insulin and /or sulfonylureas and/or glinides
- Known contraindications to Semaglutide (per FDA-approved Semaglutide label)
- Recent immunosuppressive therapy (within 90 days) or chemotherapy for malignancy within 5 years
- Moderate or severe hepatic impairment, (ALT or AST> 2 x upper limit of normal (ULN)
- Severe hypertriglyceridemia (triglycerides >500 mg/dl)
- Pregnant or breast feeding
- Any condition that may increase risk or interfere with study participation (per Investigator judgement)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Cohort 1 - SG Depot 2 mg
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2 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
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Experimental: Cohort 2 - SG Depot 4 mg
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4 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
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Experimental: Cohort 3 - SG Depot 6 mg
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6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
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Experimental: Cohort 4 - SG Depot 8 mg
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8 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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The rate of treatment-associated adverse events (AEs)
Prazo: Through study completion, up to 28 weeks for each subject
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Through study completion, up to 28 weeks for each subject
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Plasma concentration of semaglutide
Prazo: Through study completion, up to 28 weeks for each subject
|
Through study completion, up to 28 weeks for each subject
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Change in HbA1c
Prazo: Baseline (week 0), week 12
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Baseline (week 0), week 12
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Change in fasting plasma glucose from baseline
Prazo: Baseline (week 0), week 12
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Baseline (week 0), week 12
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Change in body weight from baseline
Prazo: Baseline (week 0), week 12
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Baseline (week 0), week 12
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The maximal tolerated dose (MTD) of SG Depot
Prazo: Through study completion, up to 28 weeks for each subject
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Through study completion, up to 28 weeks for each subject
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Colaboradores e Investigadores
Patrocinador
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
Outros números de identificação do estudo
- SG Depot-001
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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