Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus
Recruiting · NCT07563699 · Interventional (participants receive a specific treatment) · Lead sponsor: Mapi Pharma Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
SG Depot 2 mgSG Depot 4 mgSG Depot 6 mgSG Depot 8 mg
What this trial 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.
Who can take part
Age range
18 Years to 64 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed.
- Mapi pharma Investigational Site ISR001 - Tel Aviv, Israel