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

NCT07563699 | Not Yet Recruiting Phase 1

• 1 other identifier: SG Depot-001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Diabete Type 2

Keywords

Diabetes; Semaglutide Depot; Long-acting semaglutide; SG Depot; semaglutide LAI

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Change in HbA1c

  Baseline (week 0), week 12

• Change in fasting plasma glucose from baseline

  Baseline (week 0), week 12

• Change in body weight from baseline

  Baseline (week 0), week 12

• The maximal tolerated dose (MTD) of SG Depot

  Through study completion, up to 28 weeks for each subject

Study Arms (4)

Cohort 1 - SG Depot 2 mg

EXPERIMENTAL

Drug: SG Depot 2 mg

Cohort 2 - SG Depot 4 mg

EXPERIMENTAL

Drug: SG Depot 4 mg

Cohort 3 - SG Depot 6 mg

EXPERIMENTAL

Drug: SG Depot 6 mg

Cohort 4 - SG Depot 8 mg

EXPERIMENTAL

Drug: SG Depot 8 mg

Interventions

SG Depot 2 mg DRUG

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

Cohort 1 - SG Depot 2 mg

SG Depot 4 mg DRUG

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

Cohort 2 - SG Depot 4 mg

SG Depot 6 mg DRUG

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

Cohort 3 - SG Depot 6 mg

SG Depot 8 mg DRUG

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

Cohort 4 - SG Depot 8 mg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Participation in another investigational drug clinical study within 3 months
• History of cardiovascular or cerebrovascular disease
• Neuropathy or retinopathy or macular edema necessitating medical treatment
• Type 1 diabetes
• 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)
• Recent immunosuppressive therapy (within 90 days) or chemotherapy for malignancy within 5 years
• Moderate or severe hepatic impairment, (ALT or AST\> 2 x upper limit of normal (ULN)
• Severe hypertriglyceridemia (triglycerides \>500 mg/dl)
• Pregnant or breast feeding
• Any condition that may increase risk or interfere with study participation (per Investigator judgement)

Sponsors & Collaborators

• Mapi Pharma Ltd.: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Roy Eldor, Professor

CONTACT

972-36974243; roye@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will be divided into 4 sequential dose cohorts: 2 mg, 4 mg, 6 mg and 8 mg

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: May 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share