Diabete Type 2Phase 1/2NCT07563699
Safety, Tolerability and Efficacy of Semaglutide Depot in Subjects With Type-2 Diabetes Mellitus
A Phase 1/2 study testing SG Depot 2 mg, SG Depot 4 mg and SG Depot 6 mg in people with Diabete Type 2, run by Mapi Pharma Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabete Type 2
- What is being tested?
- SG Depot 2 mg, SG Depot 4 mg and SG Depot 6 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- 9 Aug 2026to Jun 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Mapi pharma Investigational Site ISR001
Tel Aviv, 6423906
About this study
Official title: 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.
Read the detailed description
Study Title:
A Prospective, Multicenter, Open-Label, Dose Escalation Phase I/Ila Study to Assess the Safety, Tolerability, and Efficacy of Semaglutide Depot in Subjects with Type 2 Diabetes Mellitus
Background:
Type 2 diabetes mellitus (T2DM) is a chronic condition in which the body cannot properly use insulin, leading to elevated blood glucose levels. It is often associated with overweight or obesity and can lead to serious complications if not well controlled.
Semaglutide, is a GLP 1 receptor agonist, that helps lower blood glucose by increasing insulin secretion, reducing glucagon (a hormone that raises blood glucose), slowing gastric emptying, and reducing appetite. In addition to improving glycemic control, it also supports weight loss and has demonstrated cardiovascular benefits. Semaglutide is already approved in several formulations (examples: Ozempic® for type 2 diabetes and Wegovy® for weight management), but these require once-weekly injections.
Semaglutide Depot (SG Depot) is a new, long-acting formulation developed by Mapi Pharma Ltd. It is designed to be injected once every 4 weeks (once monthly), which may make treatment easier and improve adherence for people with diabetes.
Study Design:
- Type: Phase I/Ila, open label, dose escalation study, prospective study
- Sponsor: Mapi Pharma Ltd., Ness Ziona, Israel
- Sites: Tel Aviv, Israel
- Participants: Up to 24 adults with type 2 diabetes
- Groups: Participants will be divided into 4 sequential dose cohorts: 2 mg, 4 mg, 6 mg and 8 mg
- Dose escalation: will be allowed only after review of safety data
- Conditions
- Diabete Type 2
- Being tested
- SG Depot 2 mg, SG Depot 4 mg, SG Depot 6 mg, SG Depot 8 mg
- Keywords
- Diabetes, Semaglutide Depot, Long-acting semaglutide, SG Depot, semaglutide LAI
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SG Depot 2 mgDrug
2 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
SG Depot 4 mgDrug
4 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
SG Depot 6 mgDrug
6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
SG Depot 8 mgDrug
8 mg administered subcutaneously (s.c., under the skin) once every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 - SG Depot 2 mg | Experimental | Not described Receives: Drug: SG Depot 2 mg |
| Cohort 2 - SG Depot 4 mg | Experimental | Not described Receives: Drug: SG Depot 4 mg |
| Cohort 3 - SG Depot 6 mg | Experimental | Not described Receives: Drug: SG Depot 6 mg |
| Cohort 4 - SG Depot 8 mg | Experimental | Not described Receives: Drug: SG Depot 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of treatment-associated adverse events (AEs)
Measured: Through study completion, up to 28 weeks for each subject
Plasma concentration of semaglutide
Measured: Through study completion, up to 28 weeks for each subject
Secondary outcomes (4)
Change in HbA1c
Measured: Baseline (week 0), week 12
Change in fasting plasma glucose from baseline
Measured: Baseline (week 0), week 12
Change in body weight from baseline
Measured: Baseline (week 0), week 12
The maximal tolerated dose (MTD) of SG Depot
Measured: Through study completion, up to 28 weeks for each subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start9 Aug 2026
- Primary completionMay 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabete Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Participants will be divided into 4 sequential dose cohorts: 2 mg, 4 mg, 6 mg and 8 mg
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mapi Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563699
- Sponsor's protocol ID
- SG Depot-001
- Status last verified
- Aug 2026
- First submitted
- 4 Feb 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07563699
- Acronym / sponsor ID
- SG Depot-001
- Conditions
- Diabete Type 2
- Keywords
- Diabetes, Semaglutide Depot, Long-acting semaglutide, SG Depot, semaglutide LAI
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mapi Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Aug 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Title:
A Prospective, Multicenter, Open-Label, Dose Escalation Phase I/Ila Study to Assess the Safety, Tolerability, and Efficacy of Semaglutide Depot in Subjects with Type 2 Diabetes Mellitus
Background:
Type 2 diabetes mellitus (T2DM) is a chronic condition in which the body cannot properly use insulin, leading to elevated blood glucose levels. It is often associated with overweight or obesity and can lead to serious complications if not well controlled.
Semaglutide, is a GLP 1 receptor agonist, that helps lower blood glucose by increasing insulin secretion, reducing glucagon (a hormone that raises blood glucose), slowing gastric emptying, and reducing appetite. In addition to improving glycemic control, it also supports weight loss and has demonstrated cardiovascular benefits. Semaglutide is already approved in several formulations (examples: Ozempic® for type 2 diabetes and Wegovy® for weight management), but these require once-weekly injections.
Semaglutide Depot (SG Depot) is a new, long-acting formulation developed by Mapi Pharma Ltd. It is designed to be injected once every 4 weeks (once monthly), which may make treatment easier and improve adherence for people with diabetes.
Study Design:
- Type: Phase I/Ila, open label, dose escalation study, prospective study
- Sponsor: Mapi Pharma Ltd., Ness Ziona, Israel
- Sites: Tel Aviv, Israel
- Participants: Up to 24 adults with type 2 diabetes
- Groups: Participants will be divided into 4 sequential dose cohorts: 2 mg, 4 mg, 6 mg and 8 mg
- Dose escalation: will be allowed only after review of safety data
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants will be divided into 4 sequential dose cohorts: 2 mg, 4 mg, 6 mg and 8 mg
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SG Depot 2 mg2 mg administered subcutaneously (s.c., under the skin) once every 4 weeks | Drug | Cohort 1 - SG Depot 2 mg |
| SG Depot 4 mg4 mg administered subcutaneously (s.c., under the skin) once every 4 weeks | Drug | Cohort 2 - SG Depot 4 mg |
| SG Depot 6 mg6 mg administered subcutaneously (s.c., under the skin) once every 4 weeks | Drug | Cohort 3 - SG Depot 6 mg |
| SG Depot 8 mg8 mg administered subcutaneously (s.c., under the skin) once every 4 weeks | Drug | Cohort 4 - SG Depot 8 mg |
Primary outcome
The rate of treatment-associated adverse events (AEs)
Time frame: Through study completion, up to 28 weeks for each subject
Plasma concentration of semaglutide
Time frame: Through study completion, up to 28 weeks for each subject
4 secondary outcomes
Change in HbA1c
Time frame: Baseline (week 0), week 12
Change in fasting plasma glucose from baseline
Time frame: Baseline (week 0), week 12
Change in body weight from baseline
Time frame: Baseline (week 0), week 12
The maximal tolerated dose (MTD) of SG Depot
Time frame: Through study completion, up to 28 weeks for each subject
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SG Depot 2 mg, SG Depot 4 mg and SG Depot 6 mg in people with Diabete Type 2, run by Mapi Pharma Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roy Eldor, Professor (972-36974243, roye@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of treatment-associated adverse events (AEs) (time frame: Through study completion, up to 28 weeks for each subject). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.