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RECRUITING Phase 1 / Phase 2 ClinicalTrials.gov

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

Sponsor: Mapi Pharma Ltd. • ClinicalTrials.gov ID: NCT07563699

Registry updated: 2026-08-20
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Description

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.

Interventions

  • 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

Eligibility criteria

Inclusion Criteria: 1. Adults aged 18-64 years with T2DM, BMI 25-35 kg/m2 2. On stable Semaglutide 1 mg weekly and for at least 3 months 3. HbA1c \<8%, eGFR≥60 ml/minute 4. For women: either non-childbearing potential or agreement to use acceptable contraception Exclusion Criteria: 1. Participation in another investigational drug clinical study within 3 months 2. History of cardiovascular or cerebrovascular disease 3. Neuropathy or retinopathy or macular edema necessitating medical treatment 4. Type 1 diabetes 5. Unstable weight (\> 5% change in the last 3 months) 6. Current use of insulin and /or sulfonylureas and/or glinides 7. Known contraindications to Semaglutide (per FDA-approved Semaglutide label) 8. Recent immunosuppressive therapy (within 90 days) or chemotherapy for malignancy within 5 years 9. Moderate or severe hepatic impairment, (ALT or AST\> 2 x upper limit of normal (ULN) 10. Severe hypertriglyceridemia (triglycerides \>500 mg/dl) 11. Pregnant or breast feeding 12. Any condition that may increase risk or interfere with study participation (per Investigator judgement)

Conditions

Diabete Type 2

Locations

  • Mapi pharma Investigational Site ISR001 — Tel Aviv, Israel
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record