Semaglutide Depot in Type 2 Diabetes: Safety, Tolerability, and How It Works

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase I/IIa, open-label dose-escalation study conducted at a single site in Tel Aviv, Israel. Up to 24 adults with type 2 diabetes will receive escalating doses of Semaglutide Depot (2 mg, 4 mg, 6 mg, 8 mg) to evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy. Participants must be on stable weekly semaglutide and have HbA1c under 8% with adequate kidney function. The trial aims to determine whether monthly injections can maintain glycemic control while reducing treatment burden. Key exclusions include certain cardiovascular diseases, insulin or secretagogue use, and other health conditions that could confound results.

Why it matters

Who can join: the full rules

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)

Where it's running

• Mapi pharma Investigational Site ISR001
  Tel Aviv, Israel Recruiting

Study contacts

• Study coordinator: Roy Eldor, Professor
• Email: roye@tlvmc.gov.il
• Phone: 972-36974243

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.