RecruitingPhase 1Phase 2NCT07563699

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


Sponsor

Mapi Pharma Ltd.

Enrollment

24 participants

Start Date

Aug 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called SG Depot 2 mg, a drug called SG Depot 4 mg, and others for people with diabete type 2. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSG Depot 2 mg

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

DRUGSG Depot 4 mg

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

DRUGSG Depot 6 mg

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

DRUGSG 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

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NCT07563699


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