NCT07563699RecruitingPhase 1/2
Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus
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
Source: ClinicalTrials.gov · Last updated 20 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 24 (estimated)
- First submitted
- 4 Feb 2026
- Start date
- 9 Aug 2026
- Primary completion date
- May 2028
- Lead sponsor
- Mapi Pharma Ltd.
- Diseases
- Type 2 diabetes
- NCT number
- NCT07563699
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 24
- From 9 Aug 2026 to the primary completion date, May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another investigational drug clinical study within 3 months
Other illness
- 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)
Lab values
- Moderate or severe hepatic impairment, (ALT or AST\> 2 x upper limit of normal (ULN)
- Severe hypertriglyceridemia (triglycerides \>500 mg/dl)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Tel Aviv | Israel | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.