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

NCT07563699 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

  • Diabete Type 2

Interventions

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

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

Sponsors & Collaborators

  • Mapi Pharma Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2028-04-30
Completion
2028-05-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07563699 on ClinicalTrials.gov