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SPOT-DM
Not yet recruitingPhase 2, PHASE3Semaglutide for the Prevention Of Post-Transplant Diabetes Mellitus
Lead sponsor
Asset
Semaglutide
GLP-1 agonist
Listed sites
2
Recruiting sites
—
Enrollment
74
estimated
Study population
—
Key I/E criteria
•BMI ≥25•HbA1c 5.5-6.4%•eGFR ≥30
Primary endpoint
•Postprandial glucose
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Eligibility
Who can enroll
Inclusion criteria
1. Signed and dated written informed consent.
2. Adult (≥18 years) recipients of a living or deceased donor kidney transplant
3. Between 4- and 12-weeks post kidney transplant
4. Stable kidney function defined as an eGFR > 30 ml/min/1.73m2 (CKD-EPI)
5. At risk for PTDM at the time of transplant based on the following criteria:
1. BMI ≥ 25 kg/m2, or
2. Fasting plasma glucose 6.1-6.9 mmol/L (impaired fasting glucose), or
3. 2hr OGTT plasma glucose 7.8-11.0 (impaired glucose tolerance), or
4. HbA1C 5.5-6.4% (at risk for DM or prediabetes).
Exclusion criteria
1. Established diagnosis of type 1 or type 2 DM as per Diabetes Canada (including the need for glucose-lowering therapy for hyperglycemia at the time of screening)
2. Kidney-Pancreas transplant recipient
3. Acute coronary syndrome, transient ischemic attack or stroke within 30 days prior to screening
4. History of pancreatitis
5. Personal or family history of medullary thyroid cancer or MEN2B
6. Women who are pregnant, nursing or plan on becoming pregnant whilst in the trial
7. Use of GLP1RA in the 30 days prior to screening
8. Contraindication to MRI (applicable only to those undergoing the optional MRI assessments)
9. With known or suspected hypersensitivity to semaglutide or related products
10. Patient not able to understand and comply with study requirements, based on Investigator's judgment.
11. Any other clinical condition that, based on Investigator's judgement, would jeopardize patient safety during trial participation or would affect the study outcom
12. History of glucose-galactose malabsorption syndrome
Endpoints (23)
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
4 endpointsPercentage of body fat
Time frame:24 weeks
Total fat mass
change from baseline, improvement
Change in waist circumference
Time frame:24 weeks
Waist circumference, change
change from baseline, improvement
Change in body weight
Time frame:24 weeks
Body weight, absolute change (kg)
change from baseline, improvement
Percentage of extracellular fluid
Time frame:24 weeks
descriptive
Glycemic / diabetes
5 endpoints2-hour OGTT
Time frame:24 weeks
Postprandial glucose
change from baseline, improvement
Change in fasting blood glucose
Time frame:24 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Urinary glucose excretion
Time frame:24 weeks
descriptive
Change in serum insulin
Time frame:24 weeks
change from baseline, improvement
Change in HbA1c
Time frame:24 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
MASH / liver
3 endpointsChange in liver enzymes
Time frame:24 weeks
change from baseline, improvement
Change in fibrosis level
Time frame:24 weeks
Liver stiffness (VCTE), change
change from baseline, improvement
Change in steatosis level
Time frame:24 weeks
change from baseline, improvement
Renal / kidney
5 endpointsEstimated GFR
Time frame:24 weeks
eGFR, change
change from baseline, improvement
LOINC 98979-8
GFR
Time frame:24 weeks
eGFR, change
change from baseline, improvement
LOINC 98979-8
Albuminuria
Time frame:24 weeks
uACR, change
change from baseline, improvement
LOINC 9318-7
Change in kidney oxygenation (R2*)
Time frame:24 weeks
change from baseline, improvement
Change in kidney fibrosis (ADC)
Time frame:24 weeks
change from baseline, improvement
Cardiometabolic biomarkers
4 endpointsChange in fasting lipid profile
Time frame:24 weeks
change from baseline, improvement
Systolic blood pressure
Time frame:24 weeks
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Diastolic blood pressure
Time frame:24 weeks
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Mean arterial pressure
Time frame:24 weeks
Mean arterial pressure
change from baseline, improvement
Safety / tolerability / PK
1 endpointIncidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame:24 weeks
Treatment-emergent AEs (any)
event count, event
Other (unclassified)
1 endpointNatriuresis
Time frame:24 weeks
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 1, 2026 snapshot.