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

Starting soon · Phase 1/Phase 2

Conditions studied: Diabete Type 2

In brief

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.

Key facts

Study ID

NCT07563699

Run by

Mapi Pharma Ltd.

People needed

24

Starts

2026-07-01

Expected to finish

2028-05-01

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults aged 18-64 years with T2DM, BMI 25-35 kg/m2
• On stable Semaglutide 1 mg weekly and for at least 3 months
• HbA1c <8%, eGFR≥60 ml/minute
• For women: either non-childbearing potential or agreement to use acceptable contraception

You may not qualify if…

• Participation in another investigational drug clinical study within 3 months
• History of cardiovascular or cerebrovascular disease
• Neuropathy or retinopathy or macular edema necessitating medical treatment
• Type 1 diabetes
• Unstable weight (> 5% change in the last 3 months)
• Current use of insulin and /or sulfonylureas and/or glinides
• Known contraindications to Semaglutide (per FDA-approved Semaglutide label)
• Recent immunosuppressive therapy (within 90 days) or chemotherapy for malignancy within 5 years
• Moderate or severe hepatic impairment, (ALT or AST> 2 x upper limit of normal (ULN)
• Severe hypertriglyceridemia (triglycerides >500 mg/dl)
• Pregnant or breast feeding
• Any condition that may increase risk or interfere with study participation (per Investigator judgement)

Where it is running

• Mapi pharma Investigational Site ISR001 — Tel Aviv, Israel

Full record on ClinicalTrials.gov

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