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Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus
Sponsor: Mapi Pharma Ltd.
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 64 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2026-08-09
Completion Date
2028-06
Last Updated
2026-08-20
Healthy Volunteers
No
Conditions
Interventions
SG Depot 2 mg
2 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
SG Depot 4 mg
4 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
SG Depot 6 mg
6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
SG Depot 8 mg
8 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
Locations (1)
Mapi pharma Investigational Site ISR001
Tel Aviv, Israel