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

NCT07563699 · Not yet recruiting

Last updated 2026-05-28

This clinical trial is testing the safety and side effects of a long-acting version of semaglutide, a diabetes medication, in adults with type 2 diabetes.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase1, Phase2

Type Interventional (clinical trial)

Design Non-randomized, open-label (no blinding) treatment study

Participants 24 people Planned (estimated).

Who can join Ages 18–64 · all sexes

Timeline Started 2026-05 · est. completion 2028-05

Where 1 site · Israel

What this study is testing ClinicalTrials.gov NCT07563699 ↗

Description as written by the study sponsor.

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.

Treatments tested

SG Depot 2 mg Drug

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

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

6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
SG Depot 8 mg Drug

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

Main thing measured	The rate of treatment-associated adverse events (AEs)
Sponsor	Mapi Pharma Ltd.
Conditions studied	Diabete Type 2
GLP-1 drugs	semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT07563699 ↗