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

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

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)

Conditions2

Interventions4

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