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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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
Type d'étude
Inscription (Estimé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Coordonnées de l'étude
- Nom: Roy Eldor, Professor
- Numéro de téléphone: 972-36974243
- E-mail: roye@tlvmc.gov.il
Lieux d'étude
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-
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Tel Aviv, Israël, 6423906
- Recrutement
- Mapi pharma Investigational Site ISR001
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation séquentielle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Cohort 1 - SG Depot 2 mg
|
2 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
|
|
Expérimental: Cohort 2 - SG Depot 4 mg
|
4 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
|
|
Expérimental: Cohort 3 - SG Depot 6 mg
|
6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
|
|
Expérimental: Cohort 4 - SG Depot 8 mg
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8 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
The rate of treatment-associated adverse events (AEs)
Délai: Through study completion, up to 28 weeks for each subject
|
Through study completion, up to 28 weeks for each subject
|
|
Plasma concentration of semaglutide
Délai: Through study completion, up to 28 weeks for each subject
|
Through study completion, up to 28 weeks for each subject
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Change in HbA1c
Délai: Baseline (week 0), week 12
|
Baseline (week 0), week 12
|
|
Change in fasting plasma glucose from baseline
Délai: Baseline (week 0), week 12
|
Baseline (week 0), week 12
|
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Change in body weight from baseline
Délai: Baseline (week 0), week 12
|
Baseline (week 0), week 12
|
|
The maximal tolerated dose (MTD) of SG Depot
Délai: Through study completion, up to 28 weeks for each subject
|
Through study completion, up to 28 weeks for each subject
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SG Depot-001
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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