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RECRUITING
NCT07563699
PHASE1/PHASE2

Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus

Sponsor: Mapi Pharma Ltd.

View on ClinicalTrials.gov

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

DRUG

SG Depot 2 mg

2 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

DRUG

SG Depot 4 mg

4 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

DRUG

SG Depot 6 mg

6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

DRUG

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