Clinical trial

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

Recruiting now · Phase 1, Phase 2 · 1 countries · Registry ID NCT07563699

Recruiting nowPhase 1, Phase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 64 Years

SexAll

Healthy volunteersNot accepted

ConditionDiabete Type 2

Full registry 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)

Treatments and study arms

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

Primary outcomes

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

Plasma concentration of semaglutideThrough study completion, up to 28 weeks for each subject

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Mapi pharma Investigational Site ISR001🇮🇱 Tel Aviv, Israel

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