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

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…

ClinicalTrials.gov IDNCT07563699

PhasePHASE1, PHASE2

Enrollment24

SponsorMapi Pharma Ltd.

Age18 Years

SexALL

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Conditions studied

Diabete Type 2

About this study

Interventions

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
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

Primary outcomes

The rate of treatment-associated adverse events (AEs) (Through study completion, up to 28 weeks for each subject)
Plasma concentration of semaglutide (Through study completion, up to 28 weeks for each subject)

Eligibility information

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)

Study locations

Mapi pharma Investigational Site ISR001, Tel Aviv, 6423906 Israel

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.