Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus

NCT07563699 · tracked via the Priya Life Science Israel tracker

Sponsor

Mapi Pharma Ltd

Phase

Phase 1/2

Started

2026-08-09

Last updated

2026-08-20

Condition(s) studied

Diabete Type 2

Investigational drug(s) / intervention(s)

SG Depot 2 mgSG Depot 4 mgSG Depot 6 mgSG Depot 8 mg

SG Depot 2 mg: 2 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

SG Depot 4 mg: 4 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

SG Depot 6 mg: 6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

SG Depot 8 mg: 8 mg administered subcutaneously (s.c., under the skin) once every 4 weeks

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

64 Years

Healthy volunteers

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)

Primary outcome measure(s)

The rate of treatment-associated adverse events (AEs) — Through study completion, up to 28 weeks for each subject
Plasma concentration of semaglutide — Through study completion, up to 28 weeks for each subject

Trial sites (1)

Facility	City	Region	Status
Mapi pharma Investigational Site ISR001	Tel Aviv	Israel	Recruiting

More Mapi Pharma Ltd. trials in Israel

Pharmacokinetics, Safety, Tolerability and Efficacy of a Subcutaneous Long-Acting Injection of Cariprazine (Cariprazine Depot) in Subjects Eligible for Treatment With Oral Cariprazine Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07563699 on ClinicalTrials.gov ↗ ← All trials in Israel