Long-acting semaglutide depot for adults with type 2 diabetes
Tests a long-acting form of semaglutide in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus
Key facts
- Where
- Tel Aviv, IsraelSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Source: NCT07563699, who can take part
Where in Israel
- Tel AvivTel Aviv, IsraelTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Mapi Pharma Ltd.
- Trial code
- NCT07563699
- Record updated
- 20 August 2026
- Original description
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.Read full original descriptionShow less
A Prospective, Multicenter, Open Label, Dose Escalation Phase I/IIa Study to Assess the 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, pharmacokinetics and efficacy of Semaglutide Depot in adults with T2DM.
Inclusion: 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: Participation in another investigational drug clinical study within 3 months; History of cardiovascular or cerebrovascular disease; Type 1 diabetes; Recent immunosuppressive therapy (within 90 days) or chemotherapy for malignancy within 5 years; Any condition that may increase risk or interfere with study participation (per Investigator judgement); Moderate or severe hepatic impairment, (ALT or AST> 2 x upper limit of normal (ULN); Severe hypertriglyceridemia (triglycerides >500 mg/dl); Neuropathy or retinopathy or macular edema necessitating medical treatment; 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); Pregnant or breast feeding.