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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Estimado)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Roy Eldor, Professor
- Número de teléfono: 972-36974243
- Correo electrónico: roye@tlvmc.gov.il
Ubicaciones de estudio
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Tel Aviv, Israel, 6423906
- Reclutamiento
- Mapi pharma Investigational Site ISR001
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación Secuencial
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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The rate of treatment-associated adverse events (AEs)
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in HbA1c
Periodo de tiempo: 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
Periodo de tiempo: Baseline (week 0), week 12
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Baseline (week 0), week 12
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Change in body weight from baseline
Periodo de tiempo: 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
Periodo de tiempo: 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
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SG Depot-001
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.
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