Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus (NCT07563699) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus
Israel24 participantsStarted 2026-05
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
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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
What they're measuring
1
The rate of treatment-associated adverse events (AEs)
Timeframe: Through study completion, up to 28 weeks for each subject
2
Plasma concentration of semaglutide
Timeframe: Through study completion, up to 28 weeks for each subject