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
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
-
Estimated enrollment
24
Study population
Obesity / overweight, Type 2 diabetes
Eligibility highlights
•BMI 25-35•HbA1c ≤8%•eGFR ≥60
Primary endpoints
•Treatment-emergent AEs (any)•Plasma concentration (steady state)
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
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)
Endpoints (6)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointChange in body weight from baseline
Time frame:Baseline (week 0), week 12
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
2 endpointsChange in HbA1c
Time frame:Baseline (week 0), week 12
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in fasting plasma glucose from baseline
Time frame:Baseline (week 0), week 12
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Safety / tolerability / PK
3 endpointsThe rate of treatment-associated adverse events (AEs)
Time frame:Through study completion, up to 28 weeks for each subject
Treatment-emergent AEs (any)
event count, event
Plasma concentration of semaglutide
Time frame:Through study completion, up to 28 weeks for each subject
Plasma concentration (steady state)
concentration, descriptive
The maximal tolerated dose (MTD) of SG Depot
Time frame:Through study completion, up to 28 weeks for each subject
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.